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Job Description Associate Practice Area Director I As a global leader in consulting, engineering, and commissioning services, we specialize in highly technical buildings and the systems that bring them to life. We are currently seeking a performance-driven, highly motivated leader to collaborate with our national life science and Healthcare leadership team with the opportunity to grow into and oversee this practice area in the region (located in the northeast or west region offices). This is an exciting opportunity to leverage our well-established legacy and brand with existing clients and innovative projects. In this high-level role, you will lead the efforts to pursue, win and execute pharmaceutical manufacturing, laboratory, and medical device projects. You will provide management review and oversee our regional life sciences team including the development of business plans, and target pursuits, and execute a wide variety of life science projects, organizational structures, and processes. This role will report to the Region leader of the firm. Our dynamic work environment provides the optimal setting to take your engineering career to the next level. From our supportive culture, diverse workforce, and competitive compensation to our flexible work schedule Monday to Thursday in the office for 9 hours and Friday for 4 hours remotely at home and fun social events, it is everything you will need for an exciting, challenging, and rewarding career. As a management owned private entity, we seek to reward our key leaders with ownership opportunities to drive overall performance and recognition. Job Responsibilities As an Associate Practice Area Director I, you will build a staff, in your region and maintain client satisfaction. You will generate new revenue and increase existing revenue streams. You will stay externally focused on developing and deepening your network of prospective clients and business partners, including architects and PM/CM firms, as well as key general contractors. Track leads for major pursuits, forecast a pipeline of projects and develop winning strategies and teams. Additional responsibilities: • Stay abreast of the market both regionally and nationally and keep key team members at the technical forefront of this practice area, • Develop an appropriate network within the company to facilitate the identification and sharing of relevant information between our national team for staffing and project pursuits, • Focus on ensuring technical excellence of project delivery and providing expert resolution of issues, • Develop, review, and coordinate the regional practice area business plan in conjunction with the national life science and Healthcare plan including coordinating the business plan with other practice areas, geographies, and services, • Coordinate goals with other members of the national team to help execute the business plan, • Develop strategies and tactics to explore and penetrate new clients to increase national sales and higher margin work, • Oversee project financials and interoffice / client reporting structure, • Work towards revenue generation goal of $1 million to $3 million (annual average for two years), • Develop and articulate the firm's value proposition in the market segment to develop a market distinction, • Lead and/or support sales presentations while focusing on selling integrated services, • Be an active leader and problem solver guiding our team and our partners to successfully deliver exceptional Life Science projects, • Write articles, and white papers and speak at industry conferences and events The ideal candidate will possess the necessary leadership skills to oversee all efforts for clients, demonstrating an understanding of owner / client big picture business strategies and revenue goals, as well as the ability to foresee challenges. To succeed in this role, your technical expertise must be complemented by self-motivation, relationship building skills, effective communication skills, and the ability to effectively work in a fast–paced environment. The ideal candidate will be a recognized expert in the Life Science and Healthcare market focus within the industry. Additional requirements: • Bachelor's Degree in Electrical or Mechanical Engineering; exceptional candidates may substitute significant years of experience, • 15+ years of Life Science design experience, preferably a minimum of 5 years in consulting engineering or A/E firm, • Minimum of 7 years of management experience, • 7+ years' experience in developing business for engineering, • Thorough knowledge of MEP systems, • PE registration is highly desired, • Effective team player with the ability to work independently or in a team environment As an Associate Practice Area Director with Syska Hennessy Group, you will be part of a global firm with an amazing history! We are committed to being the best, advancing engineering design practice, and supporting our clients with integrity. To make all of that happen, we rely on the talent, drive, enthusiasm, and total job satisfaction of the great people who work here. As a member of our highly collaborative team, we provide you with a flexible benefits package that reflects our respect for your workplace contributions, professional goals, and personal priorities. The personal benefits program at Syska Hennessy Group includes: • Robust, comprehensive medical, dental, vision, life insurance and supplemental benefit plans, • 401(k) plan with a generous employer matching program, • Training and professional development courses, • Professional development incentive bonuses, • Dynamic Employee Resource Groups, • Competitive Paid Time Off (PTO) policy, • Transit/parking employer stipend Syska Hennessy Group | Integrating the best minds and technology to help clients create exceptional environments The salary range listed below is for this particular job posting. Actual pay range for candidates will be commensurate with candidate's experience, skillsets and competencies and may differ based on the cost of labor in their particular location. California Pay range$110,298—$165,447 USD

Manufacturing Associate I/II — Downstream Location: San Diego, CA Schedule: Full-Time, Onsite Pay Rate: $24/hr - $37/hr Position Summary The Manufacturing Associate I/II, Downstream will support GMP manufacturing operations with a primary focus on downstream processing activities, including purification and related sub-processes, in an onsite biopharmaceutical production environment. This role is best suited for an entry- to mid-level candidate with hands-on chromatography and AKTA experience, UFDF/TFF knowledge, strong GMP documentation habits, and the ability to work effectively in a fast-paced, team-oriented setting. Key Responsibilities • Perform downstream manufacturing operations in accordance with approved SOPs, batch records, and GMP documentation requirements., • Execute purification-related processing steps and support routine manufacturing activities in assigned GMP areas., • Set up, operate, maintain, and clean downstream bioprocessing equipment, including chromatography systems, UF/DF systems, filtration skids, and mixers., • Perform hands-on chromatography work, including AKTA operation., • Support UFDF or TFF processes; manual operation experience is a plus., • Complete batch records, equipment logs, and other GMP documentation accurately and in a timely manner following Good Documentation Practices., • Assist with SOP and batch record revisions as needed., • Perform basic troubleshooting of downstream process equipment and escalate issues appropriately., • Support cleaning, sterilization, setup, and readiness activities in manufacturing areas., • Collaborate with team members to meet production goals and support process improvements. Qualifications • Associate’s or Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific discipline preferred., • Entry- to mid-level experience in pharmaceutical or biotech manufacturing preferred., • Strong downstream processing experience required., • Hands-on experience with chromatography and AKTA systems required., • Experience with UFDF or TFF required; manual operation is strongly preferred., • Understanding of the science behind downstream processing, not just task execution., • Working knowledge of cGMPs, SOPs, batch records, and GMP documentation practices required., • Experience with protein chromatography, TFF, depth filtration, viral filtration, bulk drug substance formulation, final filtration, buffer preparation, and aseptic sampling is highly desirable., • Experience with UNICORN or similar control software is a plus., • Strong communication skills, attention to detail, and the ability to work cross-functionally are important for success in this role. Work Environment / Schedule • Fully onsite, 5 days per week, • Flexible schedule based on production needs, including options such as 8:00 AM - 4:00 PM or 9:00 AM - 5:00 PM, • Earlier or later hours may be needed depending on manufacturing demands, • Some overtime expected, with occasional weekend work and advance notice, • Approximately 70% floor operations and 30% documentation

Associate Director CMC Company Description: Revelation Biosciences, Inc. is a clinical-stage biotech company dedicated to restoring immune balance by targeting inflammation through its proprietary Gemini formulation. The company is advancing a diverse pipeline of programs evaluating Gemini across multiple indications, including the treatment of chronic kidney disease, prevention of post-surgical infections, and management of acute kidney injury. Position Overview The Associate Director of Chemistry, Manufacturing, and Controls (CMC) will lead the strategic development, manufacturing, and regulatory compliance of pharmaceutical products at Revelation Biosciences. They will oversee technical projects, manage CDMO partnerships, and author/review CMC documentation for regulatory submissions (IND, BLA/NDA) to ensure compliance with global health authorities. Duties and Responsibilities CMC Leadership: • Author, review, and manage CMC sections for INDs, CTAs, BLAs, and MAAs, ensuring compliance with ICH/EMA/FDA guidelines., • Act as the CMC regulatory lead across programs, driving timelines, identifying risks, and ensuring proactive mitigation strategies in a resource-constrained, agile environment., • Serve as the primary interface with Contract Development and Manufacturing Organizations (CDMOs). Education and Skills Requirements • Bachelor’s degree (or higher) in Chemistry, Pharmacy or related scientific field., • 5-10+ years in pharmaceutical CMC development, with 3+ years in regulatory affairs or project management., • Experience supporting early-stage and clinical development programs, ideally within small or emerging biotech companies., • Experience preparing and contributing to IND submissions and in regulatory requirements (FDA/EMA) for biologics or small molecules., • Proven ability to lead projects, collaborate cross-functionally and influence in a small team setting., • Strong communication and regulatory writing skills, with attention to detail., • Strong understanding of the drug development lifecycle, especially in early clinical development environments., • Ability to operate both strategically and tactically in a lean organization with evolving priorities.

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization. Reports to: Regional Business Manager / Regional Business Director Biocon – North America – Commercial Position Overview • The Sr. Territory Account Manager (TAM) serves as the primary commercial lead for a defined geography, responsible for driving strategic account growth across priority healthcare settings with emphasis on Oncology, Retina, and Immunology., • The role requires ownership of territory performance through sophisticated account planning, deep understanding of healthcare economics, and effective engagement of complex institutional and community-based stakeholders including health systems, integrated delivery networks, infusion centers, hospital outpatient departments, specialty clinics, and priority community accounts., • The TAM is expected to evaluate each account through clinical, operational, and economic lenses to identify growth opportunities, remove barriers to adoption, and accelerate portfolio performance. Success requires strong business acumen, disciplined execution, and the ability to align internal and external stakeholders to achieve sustainable market growth., • This role partners closely with National Accounts, Market Access, Medical, Marketing, and Sales Leadership to translate enterprise strategy into account-level execution while positioning Biocon for current and future specialty portfolio success. Core Responsibilities Strategic Territory Leadership • Own territory performance and deliver quarterly and annual sales objectives across Oncology, Retina, and Immunology as dictated by business priorities., • Develop and execute integrated territory business plans that prioritize accounts based on business opportunity, patient flow, access dynamics, and competitive potential., • Continuously assess territory performance and adapt strategy based on evolving market conditions, account movement, and portfolio priorities. Institutional Account Management • Lead strategic engagement across complex accounts including health systems, infusion centers, specialty clinics, hospital outpatient departments, and targeted community practices., • Map account stakeholders and decision pathways, including clinical, operational, pharmacy, reimbursement, and administrative influencers., • Build long-term business relationships with key decision-makers including physicians, pharmacy leadership, infusion directors, practice administrators, and reimbursement stakeholders. Business Acumen & Economic Understanding • Evaluate account opportunities through economic drivers including buy-and-bill dynamics, reimbursement confidence, margin sensitivity, formulary impact, and site-of-care economics., • Understand how operational priorities, treatment protocols, contracting environment, and financial considerations influence account decisions., • Translate account economics into actionable strategies that support adoption and long-term utilization. Specialty Portfolio Execution • Prioritize Oncology as the lead specialty focus while building capability and growth across Retina and Immunology., • Deliver specialty-relevant clinical, economic, and value messaging tailored to customer priorities and treatment environments., • Support launch readiness and market development for future specialty portfolio expansion. Cross-Functional Orchestration • Partner closely with National Account Managers to ensure contract pull-through and account progression., • Collaborate with Market Access, Medical, Marketing, and Commercial Excellence to align field execution with enterprise priorities., • Bring forward field insight, customer trends, and competitive intelligence to strengthen organizational decision-making. Opportunity Acceleration & Execution Discipline • Identify barriers to product adoption and lead coordinated plans to advance account progression., • Maintain disciplined CRM documentation in Veeva, including account plans, opportunity tracking, and business intelligence., • Optimize territory investments and resources to maximize return on effort and business impact. Compliance & Corporate Responsibility • Execute all territory activities in compliance with corporate policy, legal requirements, and industry regulations., • Identify and report adverse events (AEs) and product quality complaints (PQCs) according to company procedures and timelines. Background and Experience Required • Bachelor’s degree required; advanced degree preferred., • Minimum 7 years of pharmaceutical, biotech, specialty, or institutional healthcare sales experience preferred., • Demonstrated success managing complex healthcare accounts with multiple stakeholders and long sales cycles., • Strong specialty selling experience in Oncology preferred, with Retina and Immunology highly valued., • Proven understanding of institutional account management across health systems, infusion centers, specialty clinics, and buy-and-bill environments., • Strong understanding of reimbursement models, formulary processes, account economics, and site-of-care decision drivers., • Demonstrated business planning, prioritization, and strategic execution skills., • Strong analytical ability with capability to interpret business drivers and competitive opportunity., • Effective communication skills across clinical, operational, and financial stakeholders., • Proficiency with CRM systems (Veeva preferred), Microsoft Office, and virtual platforms including Microsoft Teams and Zoom., • Proven ability to work independently while collaborating effectively across cross-functional teams., • Strong adaptability, organizational discipline, and execution focus in evolving market environments., • Ability to travel based on territory needs, including occasional evening and weekend work., • Proficiency in speaking, reading, writing, and comprehending English is required.

Position Title: Senior Computer System Validation Consultant (GxP) Work Location: San Diego, CA, 92111 Assignment Duration: 6 Months Work Arrangement: On-site Position Summary: The Quality organization is seeking an exceptional consultant/contracted specialist to join our Quality team in San Diego, CA. This is an on-site role that will lead the enhancement and maintenance of the computer system validation program. As the CSV Quality SME, you will provide critical Quality Assurance oversight and technical validation expertise for computerized systems within the San Diego site and environment. Background & Context: Based in San Diego, the site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. Key Responsibilities: Validation Lifecycle & Governance • Deliverable Management: Author, review, and approve critical validation deliverables, including Validation Plans, Risk Assessments, User Requirements (URS), Configuration Specifications, Test Scripts (IQ/OQ/PQ), and Validation Summary Reports., • Perform requalification of existing computer systems and support periodic reviews of computer systems., • System Development Oversight: Define and oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration., • System Oversight: Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations., • Audit & Inspection Support: Lead or contribute significantly to internal and external audits, assessments, and compliance plans to support future Health Authority inspections (FDA/EMA)., • Risk Management: Apply thorough knowledge of risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to appropriate leadership., • Support evaluation of existing legacy systems for technical integration and tool management., • Perform gap assessments and risk assessments on legacy systems, as required., • Align daily actions with department goals and company culture., • Actively promote teamwork across all functions with focus on our patients being the top priority., • Bachelor’s degree in Life Sciences discipline with the Life Sciences industry (Consulting or Industry) with a focus on CSV and Quality Compliance., • Regulatory Knowledge: Expert understanding of 21 CFR Part 11, GxP (211/820), GAMP 5, and EU Annex 11., • Technical Background: Strong IT/Technical background to understand the complexities of networked programs and infrastructure., • System Tools: Familiarity with laboratory, manufacturing, and quality management systems for GMP operations. Fluency in quality management systems for managing validation and change records., • Soft Skills: Excellent communication, collaborative attitude, and the ability to manage multiple projects in a complex environment., • Complete proficiency in Excel, PowerPoint and Word. Fluency with advanced/expert knowledge in data integrity and computer systems for cell and gene therapy / biotech / pharmaceutical applications., • Demonstrated ability to work independently, within prescribed guidelines, or as a team member., • Strong knowledge and competence in the utilization of core quality systems such as Change Control, Deviations, CAPA management, Document Control, Training, EDMS and LMS systems. Applicant Notices & Disclaimers • For information on benefits, equal opportunity employment, and location-specific applicant notices, click ___ At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.

Title: QA Complaint Intake Specialist / Associate Location: San Diego, CA Duration: 3 Months (12 weeks) No extension Job Description: • The QA Complaint Intake Specialist / QA Complaint Triage Associate is responsible for supporting the intake, triage, documentation, follow-up, and verification of medical device complaints associated with the iovera product line., • This role ensures complaint information is accurately captured within the electronic Quality Management System (eQMS), required information is obtained and documented, and complaint records are prepared for evaluation by the assigned QA Complaint Investigator. Responsibilities: • Receive complaint information from approved intake sources including Customer Support, field personnel, sales representatives, Medical Affairs, email communications, phone calls, and other authorized channels., • Review incoming complaint information and supporting documentation to assess reported events, identify potential complaint criteria, and initiate required follow-up activities., • Accurately document complaint information within the complaint handling module/eQMS, including but not limited to:, • Problem statement and event description, • Device and product configuration information, • Lot, serial, or batch number, • Patient impact and medical intervention details, • Event and awareness dates, • Reporter/contact information, • Returned product status, • Supporting documentation and attachments, • Perform initial complaint triage activities to assess completeness of available information, identify missing or unclear details, and determine the need for additional follow-up or escalation., • Support initial reportability screening activities by collecting and documenting information related to:, • Device malfunction or failure mode, • Seriousness and recurrence of the event, • Patient outcome and medical intervention, • Device availability for evaluation, • Potential regulatory reporting considerations, • Coordinate and document follow-up activities with internal and external stakeholders to obtain missing, incomplete, or clarifying information necessary for complaint assessment and investigation., • Request, track, and document follow-up information including:, • Exact event date and time, • Error codes and system/banner messages, • Treatment status and patient impact, • Troubleshooting activities performed, • Device usage status and return availability, • Photographs, screenshots, log files, and supporting evidence, • Track and document follow-up attempts, stakeholder responses, unresolved information gaps, and escalation activities within the complaint record., • Support verification and record review activities, including:, • Device History Record (DHR) review, • Product identity and configuration verification, • Lot/serial number confirmation, • Shipment and distribution review, • Returned product status tracking, • Functional testing request status, • Field log/logfile availability and retrieval, • Coordinate returned product retrieval and log file collection activities, when applicable, and document device status, location, chain of custody, and evaluation availability., • Create and maintain complete, accurate, and compliant complaint files in accordance with internal procedures, FDA regulations, ISO 13485, EU MDR, and applicable regulatory requirements., • Escalate potentially serious, reportable, recurring, urgent, or incomplete complaint events to QA Management and/or the assigned Complaint Investigator in a timely manner., • Ensure complaint intake, triage, documentation, follow-up, and verification activities are completed within established quality system and regulatory timelines., • Provide complaint intake metrics, aging reports, follow-up status, and triage-related information to support complaint trending, post-market surveillance, management review, audits, inspections, and continuous improvement activities., • Support additional complaint handling, quality system, and post-market surveillance activities as assigned. Education and Experience: • Minimum 1–3 years of relevant experience in Quality Assurance, medical device/pharmaceutical documentation, customer support, or another regulated industry preferred., • Medical device or pharmaceutical experience is preferred., • BS/BA degree in a scientific, technical, healthcare, or quality-related discipline is desirable; equivalent experience may be considered., • Experience with eQMS, complaint handling systems, or regulated documentation is preferred. Knowledge, Skills, and Abilities: The individual should have a basic understanding of medical device and quality system requirements; strong organizational skills; strong attention to detail; ability to accurately review and document information; ability to determine the number of complaint events from emails and supporting communications; ability to identify missing or unclear information; ability to coordinate timely follow-up; good written, verbal, and interpersonal communication skills; ability to work professorially with cross-functionally teams, Complainant, Customer Support, Field Sales, Medical Affairs, QA, Operations, and Complaint Investigators; ability to manage multiple complaint records within required timelines; and working knowledge of Microsoft Word, Excel, Outlook, and eQMS systems. Work Environment: • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job., • Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions., • Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing, and conversation., • The work environment also includes warehouse and manufacturing areas. Physical Demands: • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job., • Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions., • While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop., • Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse.

Job Title: Sr. Analytical Development Scientist / Tech Transfer Project Manager (TTPM) Job Description: Element Staffing is recruiting for a Tech Transfer Specialist with a heavy emphasis on Analytical Method Transfer for a high-growth pharmaceutical company based in San Diego. This is a fantastic opportunity to serve as the critical technical bridge between R&D, Quality Control, and external Contract Manufacturing Organizations (CMOs). The Analytical Lead will ensure that complex analytical methods for sterile injectable products are successfully validated and implemented to support a robust pipeline of life-saving medicines. Local candidates only. • Duties/Responsibilities/Qualifications:Method Transfer Leadership: Lead the technical transfer of analytical methods (HPLC, GC, Particle Matter, Karl Fischer, etc.) from R&D to commercial manufacturing sites., • Specialized Product Oversight: Provide technical expertise for complex dosage forms, including lyophilized products, pre-filled syringes (PFS), and sterile injectables., • Technical Documentation: Author and review Analytical Method Transfer Protocols, Validation/Verification plans, and Quality Risk Assessments., • CMO Management: Act as the primary analytical point of contact for external partners; oversee OOS (Out of Specification) investigations and troubleshoot deviations during transfer phases., • Regulatory Support: Provide technical data and narrative sections for CMC (Chemistry, Manufacturing, and Controls) submissions, including ANDA/NDA filings., • Method Validation: Ensure all methods meet USP/EP compendial testing standards and ICH guidelines., • Troubleshooting: Resolve method discrepancies during site-to-site transfers through detailed data analysis and "detective work." Additional Information: • Years of Experience: 5+ years in the pharmaceutical industry with a focus on Analytical Development or Tech Transfer., • Education: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field., • Shift/Travel: Standard business hours with Hybrid/Remote flexibility based on project needs., • Requirements: Mastery of ICH guidelines; proficiency in LIMS and Chromatography Data Systems (Empower/Chromeleon). Proven experience with Injectables or Lyophilized products is required., • Preferred Skills: Knowledge of Pre-filled Syringes (PFS), E&L (Extractables & Leachables) testing and moisture analysis for freeze-dried products., • Compensation: $48-75/hr DOE, • Location: San Diego, CA

LOCAL CANDIDATES ONLY PLEASE! SUMMARY Under general supervision, the Senior Manufacturing Associate, Downstream, will perform routine manufacturing activities in GMP manufacturing areas including purification and the associated sub-processes/ preparation. Operations will be performed according to Standard Operating Procedures (SOPs) and batch records. Perform manufacturing steps, execute routine batch records, and revise documents such as batch records and SOPs as needed. Drives projects and assignments and provides mentorship to associates. Flexible shift schedule and overtime may be required. JOB RESPONSIBILITIES Technical: Perform moderately complex tasks using defined protocols or procedures which contribute to the achievement of project milestones. Perform GMP manufacturing activities in assigned areas. Set-up, operate, maintain and clean downstream bioprocessing equipment, which includes but is not limited to chromatography systems, UF/DF and Viral filtration skids and mixers. Perform basic troubleshooting of bioprocess equipment. Perform manual cleaning and sterilization of manufacturing areas, parts and components. Compliance: Follow Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), plant safety guidelines and other established procedures during the manufacturing process to produce quality products. Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the manufacturing Good Documentation Practices (GDP). Draft and revise SOPs and batch records. Teamwork and Communication: Participate in regularly scheduled team meetings to discuss ideas, troubleshoot issues, go over lessons learned and identify future projects or tasks. May provide mentoring and coaching to colleagues, team members, or those with similar or less experience Act as Lead when Specialist/Supervisor is unavailable. Address production issues and report any compliance related concerns to supervisor and/or management as soon as possible. Fosters teamwork and is expected to suggest project improvements. JOB REQUIREMENTS Bachelor's degree with 6 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. High School Diploma/GED with 8 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.

Number ICIMS-2026-10237 Job function Manufacturing Job type Temporary Location Werfen - San Diego - WBH - 6260 Sequence Drive San Diego, California 92121 United States Country United States Shift 2nd Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Position Summary: The Cuvettes Production Supervisor is responsible for daily production and inventory management ensuring goals are met, quality, production, efficiency, and timely delivery of existing and new/modified products to stock. The Cuvettes Supervisor is also responsible for leading department staff in support of manufacturing activities. This role will oversee our 2nd shift. Hours: Monday-Friday, 2:00pm-10:30pm. The annual base salary range for this role is currently $80,000 to $90,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. Responsibilities Key Accountabilities Essential Functions: • Execute assigned weekly production plan as per weekly schedule., • Ensure all department work is done in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs)., • Continually work to achieve assigned production goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders., • Manage inventory to insure quality, production, and efficiency., • Maintain adequate staffing needs in support of business objectives; work to avoid overtime hours, achieve assigned production goals, meet unscheduled peaks in workload, ensure timely release of product, and to avoid back orders. Coordinate qualification and validation trials., • In accordance with company policy, process and approve staff work hours in companys time-clock system; approve time off requests ensuring business needs are continually met., • Maintain effective manufacturing and control of products in compliance with all established manufacturing specifications and control procedures., • Identify department training needs and implement appropriate training measures; mentor and train staff to enhance both individual and department performance., • Oversee maintenance of department training records., • Identify and address staffing needs with management., • Continually evaluate performance of direct reports; take appropriate disciplinary action in accordance with company policy as necessary., • Ensure safe working conditions throughout the department at all times ensuring adherence to all safety policies and procedures; work with management to identify and address safety matters and concerns., • Ensure support for the transfer of technology (product) to routine manufacturing; evaluate new technologies and the pilot work that is required to assure minimum problems with initial and subsequent manufacturing., • Manage special projects as assigned by management., • Ensure accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs., • Identify production and manufacturing issues and work to implement corrective action., • Work cross-functionally to coordinate corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints., • Ensure and maintain compliance with the Companys quality system requirements through training and adherence to policies, procedures and processes. Minimum Knowledge & Experience Required for the Position: • High school diploma or equivalent; additional training/education a plus., • Minimum of five (5) years previous related manufacturing experience within a regulated medical device manufacturing or pharmaceutical environment., • Previous lead or supervisory experience, including experience with staffing and time management., • Knowledge of lean manufacturing principles preferred., • Demonstrated ability to support business goals and objectives related to cost and manufacturing processes., • Understanding of coagulation-based manufacturing processes and company products., • Good understanding of GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO., • Working knowledge of Microsoft Office and experience with large Enterprise Resources Planning (ERP) system., • Good written and verbal communication., • Ability to work as part of a team., • Ability to identify and correct problems., • Good leadership abilities. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

Number ICIMS-2026-10349 Job function Other Job type Full-time Location Werfen - San Diego - WBH - 6260 Sequence Drive San Diego, California 92121 United States Country United States Shift 1st Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary The Staff Manufacturing Engineer applies advanced technical insight, hands-on experience, and deep knowledge of electrical systems to support complex Manufacturing Engineering activities focused on instrument electronics and printed circuit board assemblies (PCBAs) in the instrument area. This role is responsible for solving multifaceted issues in new product design transfer, manufacturing process development and optimization for medical diagnostic instruments, electrical integration, sustaining engineering, and daily production operations. The Staff Manufacturing Engineer will lead cross-functional teams on continuous improvement projects, develop and execute validation protocols and final reports, and drive manufacturing activities to ensure high-yield, reliable production of complex electromechanical instruments. The annual base salary range for this role is currently $150,000 to $175,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. Responsibilities Key Accountabilities • Function as a lead team member for design control project teams; ensure design requirements are met and comply with applicable standards., • Work as a lead project team member to complete all activities needed to conclude projects per plans., • Develop and implement process controls for new products and for transfer to manufacturing., • Develop statistically based sampling plans for design verification, design and process validation activities, new/existing product test methods, and incoming inspection to ensure they meet their predetermined requirements., • Oversee validation project teams; prepare agendas, issue meeting minutes, and participate in development of quality plans., • Write, review, and approve validations (installation qualification IQ/operational qualification OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports and final reports) for new products, processes, and equipment; ensure systems, utilities, and processes comply with the Food and Drug Administration (FDA) and industry standards., • Function as an advanced support resource; lead training initiatives of department staff as directed., • Provide statistical analysis of process and test data to support validation reports and continuous improvement., • Ensure all projects/processes are following FDA, Good Manufacturing Practices (GMP), Quality System Requirement (QSR), ISO-13485:2003 and other applicable requirements., • Actively participate in FDA inspections, ISO audits, and internal/customer audits as a subject matter expert on instrument electronics., • Provide cross-functional support by delivering required technical documentation and data to meet compliance needs., • Identify and implement opportunities for continuous improvement in Instrument yield, cycle time, and first-pass quality., • Coordinate activities with cross-functional departments, external CMs/vendors, and customers., • Maintain fiscal responsibility and budget compliance., • Ensure and maintain compliance with the company's quality system requirements through training and adherence to policies, procedures, and processes. Minimum Knowledge & Experience for the position: • Bachelor's degree (Mechanical or Electrical Engineering) or equivalent years of experience; advanced degree a plus. Six Sigma Green Belt or Black Belt methodology a plus. * Strong Electrical Engineering background with deep proficiency in electrical schematics, BOM management, and electromechanical instrument integration. * In-depth knowledge of instrument electronics and PCBA technologies, including sustaining support, integration, and technical oversight of contract manufacturers. * Excellent troubleshooting and root-cause analysis skills for electrical and instrument-level failures in a production/CM environment. * Expertise in writing and performing validations in a GMP and ISO9001 regulated environment. This also includes URS/FAT for new equipment acquisition. * Strong working knowledge of statistical tools including Design of Experiments (DOE), Statistical Process Control (SPC), process capability analysis (Cp/Cpk), and sampling plans to support validation and quality control. * Thorough understanding of FDA 21 CFR Part 820, GMP, ISO 13485, and OSHA regulations, with demonstrated experience supporting regulatory audits. * Excellent communication, organizational, and time management skills; ability to pay close attention to detail. * Excellent technical writing, verbal communication, and cross-functional leadership skills with the ability to clearly convey complex electrical and manufacturing concepts. * Good leadership ability with experience coordinating and providing technical guidance to external CMs/vendors. Travel requirements: Able to travel to visit vendors processes. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

Number ICIMS-2026-10209 Job function QA&RA Job type Full-time Location Werfen - San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 1st Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary The Document Control Supervisor is responsible for overseeing the daily activities of the Document Control group. Oversees all activities associated with change orders, SAP training sessions, quality plan tasks, document and record processing, metrics, artwork for labeling, and other tasks that help to achieve department objectives. Works closely with other Quality & Regulatory teams, other departments, and management to ensure activities effective operations. Resolves procedural and process issues as well as recommends ares for improvement. Manages direct reports to comply with company policies and meet department goals. This position is the subject matter expert in document control processes and procedures. Ensures all work is completed in accordance with Inova Quality Management System. Responsibilities Key Accountabilities The main responsibilities of this role include: • Regulatory Compliance & Quality Management: Maintains a strong understanding of document control requirements within Quality Management Systems (QMS) and ensures compliance with changing regulations. Includes overseeing the document lifecycle and ensuring all Change Orders (CO) meet established requirements for accurate completion and implementation. Responsible for maintaining compliance with relevant regulations and procedures. Supports and represents department during audits and regulatory inspections, collaborating with Regulatory Affairs to ensure submissions meet all requirements., • Document Control Processes: Manages and optimizes document control processes, including efficient handling of Cos to ensure errors, inconsistencies, and delays are minimized. Drafts, updates, and trains staff on Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains expertise in SAP for document-related transactions, including those related to the Material Master. Determines appropriate document types, manages document formats, and provides administrative guidance to ensure accuracy and efficiency of document management across various platforms, including Word, Excel, and PDFs. With stakeholders, manages the creation and maintenance of document control processes related to Product Lifecycle. Overees scheduling and organizing SAP training and Quality related training plans and ensures training records are maintained. Develops, maintains and reports document control and SAP and Quality related training metrics., • Labeling and Translation Processes: Responsible for the product labeling processes to ensure all labeling materials meet regulatory requirements and align with company branding. Collaborates with R&D, Marketing, and Regulatory Affairs to align labeling with product specifications. Provides training and guidance to team members on labeling standards and procedures. Manages timelines and deliverables for labeling requests., • Process Improvement & Technology: Drives process improvements by promoting technological solutions, identifying bottlenecks, and implementing processes to enhance efficiency. With department management, develops and maintains an electronic document strategy, manages metrics, and may participate in or lead Quality Process Programs (QPPs) to ensure continuous improvement. Assesses current processes, implements feedback mechanisms, assess risks, and establishes disaster recovery processes to mitigate document control risks. The goal is to create a streamlined and resilient document control system that adapts to evolving business needs., • Collaboration & Communication: Effective communication and collaboration are critical in this role. Collaborates with internal customers to understand their needs and ensure seamless processes, including other departments and Werfen Technology Centers. Communicates process changes clearly to stakeholders and provides formal training to ensure all departments are aligned. With department leadership, partcipates in discussions regarding transformational strategies to ensure document control processes support broader business objectives, while also prioritizing and addressing urgent or critical issues as they arise., • Administrative Tasks: Responsible for administrative activities including, but not limited to, determining document storage requirements, and overseeing the secure destruction of documents when necessary. Audits internal processes to ensure accuracy, completeness, and adherence to quality standards, ensuring document control activities are thoroughly documented and compliant with both internal and external requirements. Networking/Key Relationships • Quality Teams (Quality Assurance, Quality Engineering, Quality Production Support), • Regulatory Team, • Manufacturing Teams, • Operations and Supply Chain Teams, • Marketing Teams, • Human Resources and Legal, • Research and Development Teams, • Werfen Manufacturing Sites and Affiliates Qualifications Minimum Knowledge & Experience required for the position:Education: • Bachelor's degree in Quality Management, Engineering, Life Sciences, Business Administration, or related discipline required., • At least 5 years of experience in document control, quality management, or related field within the medical device, pharmaceutical, or biotech industries required. Skills & Capabilities • Strong understanding of regulatory requirements such as 21 CFR Part 820, ISO 13485, ISO 15223, ISO 20417, ISO 18113, and IVDR - Language requirements for manufacturers., • Proficiency in document control software and tools, including experience with electronic Document Management Systems (eDMS), SAP (for COs, Material Master, document storage), and general office software (e.g., Microsoft Word, Excel, PDFs, EasyLabel, Codesoft, Automated Labeling System)., • Experience in drafting, updating, and managing SOPs, COs, training records, product item masters, and labeling in a regulatory context., • Familiarity with industry standards for document control, including document formatting, naming conventions, and lifecycle management., • Basic business acumen, including understanding of employment law, administrative policy compliance, expense management and business communications., • Demonstrated ability to supervise operations and direct reports, with a focus on building high-performing teams and fostering a culture of accountability and continuous improvement., • Project management experience, with the ability to participate in and/or lead projects, prioritize tasks, and work efficiently under pressure to meet deadlines. Salary: $70K-$110K If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Salary range $70K-$110K. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit ___ for more information. The Associate Director, HCP Personal Promotion will serve as a key member of the marketing team leading the development and execution of Jazz's HCP Personal Promotion strategy for the Sleep Franchise. This role is responsible for branded and unbranded campaign and messaging asset development, brand story pullthrough, sales team engagement, training strategy, POA leadership, and personal promotion performance measurement. The person in this role will serve as the primary liaison to the Field Sales team and play a pivotal role in ensuring cohesive and highimpact personal promotion execution. Serving as a team player, showing up as a leader, and demonstrating the Jazz corporate values daily will be critical success factors to the role. • Lead HCP branded and unbranded Personal Promotion strategy., • Own personal promotion asset development, incorporating campaign, messaging and brand storytelling to the priority personal promotion resources., • Conduct asset needs assessments and provide inputs to qualitative and quantitative market research and advisory boards., • Serve as the primary liaison to the Field Sales organization., • Lead Field Advisory Board (FAB) strategy, including content development and insight integration., • Develop and execute a Field Sales Engagement strategy and activation plan., • Be the Marketing Lead for New Hire Sales Training, ensuring deep understanding of brand strategy., • Drive ongoing sales team upskilling through advanced training initiatives., • Develop and maintain sales training materials., • Lead crossfunctional POA content development and meeting strategy., • Serve as a consulted partner for field communications planning and messaging alignment., • Assess effectiveness of personal promotion tactics, messages, and field execution., • Deliver actionable insights and recommendations for asset optimization., • Partner closely with Access, Sales, NonPersonal Promotion, Omnichannel, and Scientific Communications teams., • Ensure prioritized alignment of messaging and tactical execution personal promotional channels., • Manage personal promotion budget lines including work orders, accruals, and forecasts., • Oversee SOW creation and tracking., • Bachelor's degree required., • 5+ years of U.S. pharmaceutical HCP marketing experience., • Experience in field sales and/or HCP personal promotion strongly preferred., • Demonstrated success leading crossfunctional initiatives., • Strong communication, analytical, and project management skills., • Exceptional problem solving and decision-making capabilities., • Demonstrated ability to partner effectively with Sales teams., • Ability to manage budgets, timelines, and agency partners., • The position will primarily be home-based, with the expectation to travel for meetings as necessary. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $160,000.00 - $240,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: ___.

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW Syner-G is seeking a Facilities Technician III with 5–10 years of experience to support the operation, maintenance, and repair of GMP and non-GMP facility systems, utilities, and equipment. This role is responsible for performing advanced maintenance activities, troubleshooting complex issues across multiple building systems, and supporting reliability and compliance requirements in laboratory, manufacturing, and utility environments. The Facilities Technician III works with minimal supervision, handles complex technical challenges, and may guide junior staff as needed to ensure safe and efficient facility operations. WORK LOCATION Travel to client sites may be required depending on project demands and client expectations. KEY RESPONSIBILITIES (This list is not exhaustive and may be modified as needed.) • Perform advanced preventive and corrective maintenance activities on mechanical, electrical, HVAC, utility, safety, and building systems across GMP and non-GMP areas., • Receive, prioritize, and execute work order requests from employees, tenants, and internal customers, ensuring timely and efficient response to facility needs., • Troubleshoot and resolve complex technical issues involving HVAC systems, electrical distribution, plumbing, mechanical utilities, generators, environmental controls, and related infrastructure., • Inspect facility systems and equipment to identify maintenance needs, operational risks, or abnormal conditions and escalate issues when required., • Make repairs directly when possible and coordinate specialized contractors or vendors when complex repairs are needed., • Work independently with minimal supervision while handling complex maintenance tasks requiring strong technical judgment., • Maintain accurate maintenance records, including work orders, equipment logs, inventory tracking, and compliance-related documentation., • Support calibration activities and equipment reliability programs as needed., • Ensure compliance with all safety regulations, facility procedures, and applicable GMP or regulatory standards., • Provide technical support, guidance, or mentoring to junior technicians as required., • Collaborate with cross-functional partners including Laboratory Operations, Engineering, Quality, Safety, and other stakeholders to support continuous facility operations., • Identify and recommend improvements, upgrades, or cost-effective solutions that enhance system reliability, energy efficiency, or facility performance. Education • High school diploma required; technical trade school certifications or equivalent field experience considered., • 5–10 years of relevant experience in facility maintenance, utilities support, or mechanical/electrical building systems., • Strong technical skills in HVAC, electrical, plumbing, mechanical systems, and building utilities., • Ability to troubleshoot and resolve complex facilities issues independently., • Proficient in reading schematics, blueprints, technical manuals, loop diagrams, and Pdummyamp;IDs., • Familiarity with Building Management Systems and Computerized Maintenance Management Systems (CMMS)., • Effective communication and customer service skills., • Ability to perform physical labor and work across multiple facility environments. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. The expected salary range for this position is $31 to $45 hourly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job DescriptionJob Title: Cleanroom Production Operator Job Description The Cleanroom Production Operator supports daily production and packaging activities in a regulated manufacturing environment, working in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). This role focuses on achieving production goals, maintaining product quality, and ensuring accurate documentation while operating in a cleanroom setting. Responsibilities • Perform daily production and packaging activities in strict accordance with GMP and all relevant SOPs., • Work consistently to achieve assigned production goals and respond to unscheduled peaks in workload to ensure timely product release and prevent back orders., • Collaborate with the Team Leader and other stakeholders to understand critical raw materials, in-process procedures, and product specifications., • Assist in identifying and implementing corrective actions for technical problems related to raw materials and finished products., • Perform in-process quality checks on sub-assemblies and finished products to ensure compliance with specifications and quality standards., • Identify and troubleshoot line issues and other production problems, and promptly notify the Team Leader or appropriate personnel of required corrective actions., • Maintain accurate, complete, and legible records and documentation in accordance with Good Documentation Practices (GDP) and related SOPs., • Use a computerized Materials Resource Planning (MRP) or Enterprise Resource Planning (ERP) inventory system as required to report lot-controlled ingredients on batch records., • Operate production machinery and equipment safely and efficiently while following all manufacturing procedures., • Support qualification and validation activities as needed, following established protocols and documentation requirements., • Close work orders accurately and on time, ensuring all associated documentation and system entries are complete., • Participate in training and ongoing learning to quickly comprehend and support coagulation-based manufacturing processes., • Follow all cleanroom, safety, and quality procedures, including the correct use of personal protective equipment and adherence to facility rules., • Communicate clearly with supervisors and team members about production status, issues, and improvement opportunities., • Demonstrate reliable attendance and punctuality to prevent bottlenecks in the production process.Essential Skills, • At least two (2) years of previous assembly or packaging experience., • Previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred., • Demonstrated ability to understand and follow SOPs, including the ability to explain how SOPs were used in a prior role to achieve production and quality goals., • Strong understanding of Good Documentation Practices (GDP) and the ability to explain how GDP was applied in previous positions., • Familiarity with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), FDA regulations, and ISO standards., • Ability to quickly comprehend coagulation-based manufacturing processes., • Experience with machine operation in a production environment., • Experience with quality assurance, packaging, inspection, and computer operation in a manufacturing setting., • Working knowledge of Microsoft Office applications., • Experience with large Enterprise Resource Planning (ERP) systems, such as SAP or similar platforms., • Ability to use computerized Materials Resource Planning (MRP) systems to record and track lot-controlled materials., • Strong attention to detail and accuracy in documentation and recordkeeping., • Ability to work flexible hours, including overtime and occasional Saturdays, as required., • Reliable attendance and strong sense of responsibility to support continuous production flow.Additional Skills & Qualifications, • Previous experience in medical device or pharmaceutical manufacturing involving coagulation-based processes., • Knowledge of qualification and validation trials and participation in related activities., • Familiarity with additional manufacturing acronyms and terminology, demonstrating comfort with manufacturing lingo., • Experience closing work orders and documenting production activities in ERP or MRP systems., • Ability to clearly describe machines operated, computer systems used, and prior experience with systems such as SAP., • Comfort working in a regulated cleanroom environment with strict procedural and documentation requirements., • Strong communication skills to effectively interact with team members, supervisors, and cross-functional partners., • Demonstrated ability to learn new processes and reach higher levels of responsibility as an operator.Why Work Here? The organization invests in each employee’s growth and integration into the team, including those in contract roles. Employees are invited to quarterly company events, often featuring catered lunches and shared celebrations that foster a sense of community. Upon conversion to a permanent role, individuals receive a pay increase, reflecting recognition of their contributions and development. The culture emphasizes reliability, teamwork, and ongoing learning, offering opportunities to advance skills, take on additional responsibilities, and build a long-term career in a regulated manufacturing environment. Work Environment This position is based in a cleanroom manufacturing environment on the second shift, typically from 1:30 p.m. to 10:00 p.m. Work is performed on the production floor with exposure to machinery and equipment, and the area can be loud at times; hearing protection and earplugs are provided as needed. The environment follows strict GMP, SOP, and GDP requirements, as well as FDA and ISO guidelines, and involves use of computers, MRP/ERP systems, and production equipment. The dress code requires pants (leggings are not permitted), and no makeup or lipstick may be worn in the cleanroom. If necklaces are worn, they must be tucked into the shirt. Glasses must be used with side shields while on the manufacturing floor. Headphones are not allowed on the floor, and cell phone use is restricted to maintain focus and safety. After an initial training period of approximately six weeks, overtime may be required; some overtime is voluntary and some may be mandatory, with one to two weeks’ notice provided. Flexibility to work overtime, including potential Saturday shifts, is important. Reliability and consistent attendance are critical, as the absence of a single team member can create bottlenecks in the production process. Job Type & Location This is a Contract position based out of San Diego, CA. Pay and Benefits The pay range for this position is $20.35 - $20.35/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program About Aerotek We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

Position Title: Senior Computer System Validation Consultant (GxP) Work Location: San Diego, CA, 92111 Assignment Duration: 6 Months Work Arrangement: On-site Position Summary: The Quality organization is seeking an exceptional consultant/contracted specialist to join our Quality team in San Diego, CA. This is an on-site role that will lead the enhancement and maintenance of the computer system validation program. As the CSV Quality SME, you will provide critical Quality Assurance oversight and technical validation expertise for computerized systems within the San Diego site and environment. Background & Context: Based in San Diego, the site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. Key Responsibilities: Validation Lifecycle & Governance • Deliverable Management: Author, review, and approve critical validation deliverables, including Validation Plans, Risk Assessments, User Requirements (URS), Configuration Specifications, Test Scripts (IQ/OQ/PQ), and Validation Summary Reports., • Perform requalification of existing computer systems and support periodic reviews of computer systems., • System Development Oversight: Define and oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration., • System Oversight: Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations., • Audit & Inspection Support: Lead or contribute significantly to internal and external audits, assessments, and compliance plans to support future Health Authority inspections (FDA/EMA)., • Risk Management: Apply thorough knowledge of risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to appropriate leadership., • Support evaluation of existing legacy systems for technical integration and tool management., • Perform gap assessments and risk assessments on legacy systems, as required., • Align daily actions with department goals and company culture., • Actively promote teamwork across all functions with focus on our patients being the top priority., • Bachelor's degree in Life Sciences discipline with the Life Sciences industry (Consulting or Industry) with a focus on CSV and Quality Compliance., • Regulatory Knowledge: Expert understanding of 21 CFR Part 11, GxP (211/820), GAMP 5, and EU Annex 11., • Technical Background: Strong IT/Technical background to understand the complexities of networked programs and infrastructure., • System Tools: Familiarity with laboratory, manufacturing, and quality management systems for GMP operations. Fluency in quality management systems for managing validation and change records., • Soft Skills: Excellent communication, collaborative attitude, and the ability to manage multiple projects in a complex environment., • Complete proficiency in Excel, PowerPoint and Word. Fluency with advanced/expert knowledge in data integrity and computer systems for cell and gene therapy / biotech / pharmaceutical applications., • Demonstrated ability to work independently, within prescribed guidelines, or as a team member., • Strong knowledge and competence in the utilization of core quality systems such as Change Control, Deviations, CAPA management, Document Control, Training, EDMS and LMS systems.

Position Title: Senior Data Integrity Consultant (GxP) Work Location: San Diego, CA, 92111 Assignment Duration: 6 Months Work Arrangement: On-site Position Summary: The Quality organization is seeking an experienced Senior Data Integrity Consultant to join our team in San Diego, CA. In this on-site contracted role, you will be integral to the deployment and oversight of the site's Data Integrity (DI) program while providing expert Computer System Validation (CSV) leadership. Background & Context: This is for the Poseida location in San Diego, CA. Our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies. Key Responsibilities: Data Integrity Program Leadership • Lead the deployment, enhancement, and effective implementation of the site's Data Integrity program., • Conduct and execute gap assessments of data integrity practices, identifying risks and developing comprehensive site mitigation plans., • Ensure the Quality System satisfies compliance requirements associated with: Data integrity regulations (FDA 21 CFR Part 11/211/820, EU Annex 11, EudraLex Volume 4), Audit trail review and data governance, Data quality, backup, recovery, and security controls., • Act as the primary Quality Assurance voice for DI standards, ensuring strict alignment with global quality expectations., • Provide expert QA oversight during the development of Solution Development Lifecycle (SDLC) documents (URS, Design Specs, Test Plans) to ensure DI and ALCOA+ principles are embedded at the architecture level., • Audit and approve the implementation of engineering controls, including audit trail configurations, restricted user access, and secure data mapping. Validation & Computer Systems Assurance • Author, review, and approve critical validation deliverables, including: Validation Plans, Risk Assessments, and User Requirements (URS), Configuration Specifications, Test Scripts (IQ/OQ/PQ), Validation Summary Reports and Periodic System Reviews., • Perform requalification of existing computer systems and support periodic reviews to maintain a validated state., • Act as the Quality Lead for project teams, guiding the implementation of validation, security, and compliance deliverables throughout the system lifecycle., • Oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release and update., • Support evaluation and gap assessments of legacy systems for technical integration and remediation planning. Operational Compliance & Audit Readiness • Lead and execute: Periodic System Reviews (PSR): Evaluating the ongoing "state of control" and effectiveness of the system's data lifecycle. User Account Reviews (UAR): Ensuring strict segregation of duties and appropriate GxP access levels. Change Control Oversight: Leading Quality impact assessments to ensure changes do not compromise the validated state or data reliability., • Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans., • Apply risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to leadership., • Prepare management reports regarding compliance operations, project progress, and the overall validated state of site systems. Continuous Improvement & Collaboration • Drive the enhancement of Quality Compliance operating procedures to bridge gaps between local manufacturing standards and global quality expectations., • Interface between local site manufacturing quality standards and global standards to ensure a unified compliance posture., • Act as a high-level consultant to technical SMEs, providing the "Quality lens" on complex data flow and system integration challenges., • Align daily actions with department goals and company culture, actively promoting teamwork across all functions with a patient-first mindset. Qualification & Experience: Education & Experience • Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered)., • Minimum of 8+ years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred), with a focus on Data Integrity, Computer System Validation, and Quality Compliance. Regulatory Knowledge • Expert understanding of: FDA 21 CFR Part 11, 210/211, and 820; EU EudraLex Volume 4 (Annex 11 and Chapter 4); GAMP 5 and risk-based validation approaches; ALCOA+ principles and data governance frameworks. Technical Skills • Strong knowledge of Quality Management Systems in a cGxP manufacturing environment., • Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training., • Hands-on experience with Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), and laboratory/manufacturing systems., • Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word). Competencies • Exceptional written and verbal communication skills, with the ability to author and revise SOPs, work instructions, and validation documents., • Strong attention to detail and ability to manage multiple projects simultaneously in a fluid, dynamic, and fast-paced environment., • Proven ability to work independently, within prescribed guidelines, or as part of a collaborative team., • Experience developing training materials and delivering training to employees on DI and CSV topics., • Ability to lift up to 20 pounds as needed. Working Conditions & Physical Demands (If Applicable): Ability to lift up to 20 pounds as needed. Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed.

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future. To strengthen our team in San Diego, we are looking for you as a(n) Director of Business Development - BioPharma. The Director of Business Development, Biopharma - U.S. Market is a senior commercial leader responsible for driving revenue growth, expanding market penetration, and strengthening strategic customer relationships across the United States. This leader will oversee all U.S. commercial activities for Wacker's CDMO offerings, including pDNA, mRNA, and microbialderived protein services across early and latestage programs. This role requires a visionary, resultsdriven leader with deep experience in the U.S. biopharmaceutical ecosystem, strong customer networks, and a proven track record of building and developing highperforming business development, account management, and technical commercial teams. The Head of Business Development will shape and execute regional gotomarket initiatives, foster a culture of excellence and customercentricity, and position Wacker Biopharma as a trusted partner for innovative biologics development and manufacturing. Key Responsibilities • Develop and implement a comprehensive U.S. regional sales strategy aligned with global commercial objectives, focused on revenue growth, market penetration, and profitability across Biopharma CDMO capabilities (pDNA, mRNA, and proteins derived from microbial expression systems)., • Recruit, lead, mentor, and develop a highperforming regional sales organization, including Business Development Managers/Account Managers, and Subject Matter Experts; foster a culture of accountability, continuous improvement, and customer success., • Drive strategic business development initiatives that identify new opportunities, expand the customer base, and strengthen Wacker Biopharma's presence across U.S. biotech and pharmaceutical hubs., • Establish ambitious sales targets, implement robust forecasting methodologies, and manage the regional sales pipeline to consistently meet or exceed revenue goals., • Monitor regional market trends, competitive activity, customer needs, and emerging technologies to inform strategic planning, product development, and marketing programs., • Partner closely with Marketing, Project Management, R&D, Operations, and Legal to ensure seamless gotomarket execution, new offering launches, and differentiated customer experiences., • Manage strategic key account relationships, ensuring exceptional service delivery and identifying opportunities to expand longterm partnerships., • Develop and manage the U.S. regional sales budget, optimizing resource allocation to enhance sales efficiency and commercial ROI., • Oversee the effective use of CRM systems (e.g., Salesforce), ensuring data integrity, reporting accuracy, and continuous refinement of commercial processes., • Perform other duties as assigned Job Qualifications: • Bachelor's degree required; advanced degrees preferred., • Minimum of 10 years of experience within life science commercial or business development organizations., • Proven ability to translate market knowledge into impactful sales strategies and execution plans., • Strong financial competence, including experience with sales forecasting, budgeting, and commercial analytics., • Outstanding leadership, coaching, and teambuilding capabilities across multilayered commercial functions., • Exceptional communication, negotiation, and presentation skills, with the ability to influence at all organizational levels., • Deep understanding of the sales cycle for complex biologics CDMO services and solutions., • Proficiency in CRM software (e.g., Salesforce) and sales analytics platforms., • Ability to excel in a fastpaced, complex, and globally integrated environment., • Demonstrated track record of consistently exceeding sales targets and driving significant revenue growth in a competitive market., • Proven experience leading and developing teams that include Business Development, Account Management, and technical Subject Matter Experts., • Experience with direct sales models and channel partner management., • Ability to travel as required. Key Experience • Strong hunting and prospecting abilities with proven pharma/biotech business development or direct sales experience and a robust network within innovative biopharma communities across North America (and ideally Europe/Asia)., • Strong negotiation and presentation skills, business acumen, and commercial judgment., • Experience using Salesforce or similar CRM systems to manage leads, pipelines, and opportunities., • Excellent interpersonal and communication skills; adaptable, selfmotivated, and capable of working independently., • Strategic and critical thinker with the ability to process market insights, identify opportunities, and design effective commercial strategies., • Highly collaborative, able to operate effectively within a matrix organization and motivate colleagues across global locations., • Foundational understanding of biologics manufacturing and core scientific concepts related to bioprocessing and biotherapeutics (e.g., proteins, antibodies, DNA, gene therapies, cell therapies)., • Foundational understanding of intellectual property considerations across North America/Europe/Asia., • Foundational understanding of the regulatory environment affecting pharma/biotech in North America/Europe/Asia. The anticipated salary range for candidates who will work in San Diego is $205,000-220,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi state employer and this salary range may not reflect positions that work in other states. What do we offer? WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development. • Compensation and Incentive plans, • Medical, Dental, and Vision Insurance effective day 1, • Paid Time Off in addition to personal days and holidays, • Paid parental leave, • Wellbeing fund, • Flexible hybrid work arrangements, • 401(k) with company match, • Education Assistance Program, • Career development and advancement opportunities Wacker is an Equal Opportunity Employer. We actively promote the equality of opportunity for all who are qualified and bring the requisite experience, talent, skill and potential, without regard to age, disability, sex, race, religion or belief, marriage/civil partnership, pregnancy/maternity, sexual orientation, or any other protected characteristics. We welcome all applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

Save time and apply through your LinkedIn account. Click the button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number. We look forward to discovering your talents. POSITION SUMMARY: At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team - we rise by lifting others up and believe in the power of working together for the collective win. That's why we need you-to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive. Join us as a Director, Operational Excellence, and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives. How you will make an impact The Director, Operational Excellence, works with functional leaders and teams to identify opportunities for Halozyme to apply lean principles and continuous improvement tools and techniques to improve the effectiveness and efficiencies of our processes and procedures. The focus can encompass all functions at Halozyme, with the agreement and collaboration of the department leader. Core activities include participating in high-impact project teams and leading operational excellence assessments and discussions aimed at identifying opportunities to improve our operational processes and procedures. The team may also assess approaches to improve speed and clarity of team decision making, and opportunities for operational improvements to increase quality, speed, and cost while assuring we deliver with high quality for our customers and patients. In this role, you'll have the opportunity to: • Apply intensive and diversified knowledge of Operational Excellence (OE) principles and practices to lead a variety of projects aimed at driving operational transformation and improvement across multiple functions., • Challenge the status quo and identify opportunities for improvement, chart the course for improvement actions, and take accountability for rigorous execution and delivery of improvement projects., • Collaborate and lead constructive debates with teams to prioritize opportunities, manage on-going projects, discuss challenging issues, and solve problems., • Develop and contribute to the advancement of the overall OE strategy and implementation of tools and systems that support continuous process improvement, enhance daily management systems, and drive culture change., • Provide training, mentoring, and day-to-day OE coaching to personnel to achieve expected business results., • Design and publish performance management reports and OE updates for multiple audiences, including executive level updates, team communications, and broad program updates for all Halozyme staff., • Cultivate and maintain strong cross-functional relationships and contribute to our positive environment while influencing teams across the corporation to adopt a continuous improvement mindset., • Build/improve business processes related to Operational Excellence., • Author Standard Operating Procedures (SOPs) describing essential functions., • Comply with established company policies and procedures, objectives, quality assurance program, and safety and environmental standards, and current Good Manufacturing Practices To succeed in this role, you'll need: • Bachelor's degree in a technical, life sciences, or related field; Master's degree preferred., • 12+ years of experience in Operational Excellence with extensive knowledge of LEAN, Six Sigma, and other Operational Excellence tools, • An equivalent combination of experience and education may be considered, • Six Sigma Black Belt preferred., • Experience in Medical Device and Pharmaceutical industry preferred., • Proficiency in project management tools and MS Office., • Strong leadership, communication, and problem-solving skills., • Ability to influence and manage in a matrixed environment., • Familiarity with GMP, FDA guidelines, and regulatory requirements preferred., • Experience quantifying business benefit on operational excellence initiatives., • Leadership: Demonstrates ability to inspire, guide, and develop teams to achieve continuous improvement and organizational goals., • Strategic Thinking: Applies long-term vision and planning to align OE projects with business objectives and prepare the organization for future growth., • Risk Identification & Mitigation: Proactively identifies potential risks and implements effective mitigation strategies to ensure project success. In return, we offer you: • Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching., • Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement., • A collaborative, innovative team that works as one to amplify your impact-on your career, the work you do and patients' lives. The most likely base pay range for this position is $180K - $252K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards. Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Accessibility and Reasonable Accommodations: Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at ___. To view all our open positions, please visit our ___. Additionally, our benefit offerings can be found ___.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This role provides clinical pharmacology and pharmacometrics leadership for assigned development programs and may be based in San Diego, CA or Madison, WI. The position is responsible for contributing to clinical trial design, authoring key protocol and regulatory sections, and performing hands-on PK/PD analyses to guide dose selection and program strategy. It oversees the preparation and authorization of PK analysis reports, CSR content, and clinical pharmacology components of global regulatory submissions Responsibilities • Provide Clinical Pharmacology and pharmacometrics leadership for designated programs, contribute to design of clinical trial protocols and relevant sections in Investigational Brochure (IB), conduct hands-on analysis of clinical or translational PKPD data, support dosing strategies and clinical pharmacology planning. Authorize clinical PK analysis reports and relevant sections in the Clinical Study Report (CSR)., • Provide high quality documentation of clinical pharmacology analysis compatible with global regulatory submission requirements. Authorize clinical pharmacology modules of CTD to support global filings of marketing application., • Provide timely communication of analysis results and interpretation with drug development teams., • PhD or PharmD in the field of pharmacokinetics, pharmacology or pharmaceutical science,, • 3 years of pharmaceutical industry experience in clinical-stage drug development., • Good understanding of FDA/EMA/ICH guidance related to clinical pharmacology, • Established experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin with familiarity of authorizing PK study report., • PBPK/PD modeling California pay range $120,000—$170,000 USD Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job DescriptionDescription: Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as an approved drug for the treatment of cancers and immune-mediated inflammatory diseases. We are currently seeking a highly motivated, creative CMC drug substance professional to join our CMC team in San Diego. This candidate will report to the executive director and head of CMC. This candidate is expected to work closely with Kumquat internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. This is a position with responsibility for synthetic route design and scouting, process development and manufacturing. The ideal candidate will have an in-depth understanding in all aspects of modern synthetic chemistry, process development, and non-GMP/GMP manufacturing. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will have the opportunity to work on multiple programs within the company’s pipeline which comprises potentially first-in-class approaches & novel-novel targets. Role responsibilities • Evaluate available candidate synthetic routes and develop stage appropriate route modification and process optimization strategies., • Select external CRO/CDMO partners based on project needs and the external parties’ technical capabilities, quality system, and track records., • Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget., • Plan and oversee drug substance process optimization, GMP manufacturing, and stability evaluation., • Track process development/validation history and manage CMC drug substance related documents in support of life cycle of quality improvement and regulatory filing/updates., • Work closely with a cross-functional team within and outside of the CMC department to align with key stakeholders (CMC, clinical, quality assurance and regulatory, etc.)., • Author and review CMC drug substance related sections for regulatory filing and annual updates., • Stay current on industry trends and regulatory requirements to ensure delivery of quality products under non-GMP and GMP environments., • Prepare and communicate research results in both oral and written format., • Supervise junior CMC Drug Substance team members., • Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence.Requirements:, • Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 10 years of related experience (title for this position will be commensurate with the candidate’s experience and qualifications), • Strong synthetic organic chemistry knowledge and problem-solving skills., • In-depth knowledge of industry practices in drug substance manufacturing and supply., • Desire and ability to maintain constructive working relationship with the CMC analytical development team and the CMC drug product team., • In-depth knowledge of cGMP regulations and compliance., • Track record of accomplishment in managing CMC drug substance projects at early and late development stages., • Direct experience with small molecule API NDA filing is preferred., • Ability to enable external CRO/CDMO to achieve project goals on time and under budget., • Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment. Salary Description: $170k - $275k

Job DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: Reporting to the Senior Manager, Biomarker Operations, the Manager, Biomarker Operations is responsible for managing operational aspects of the clinical biomarker projects. This position will be responsible for managing the biomarker operation of Artivas clinical studies by coordinating sample-related operations with Clinical Operations, contract executions, and communication between the Translational Science group with external contract research organizations (CRO) and internal lab personnel. The successful candidate will have strong communication and project management skills. Understanding and experience with drug development and clinical trial process is a prerequisite for this position. Duties/Responsibilities: • Oversee day-to-day biomarker operations of Artivas clinical trials including but not limited to execution of biomarker operations with external vendors, ensuring CROs meet all key deliverables and timelines, • Working closely with the translational leads, manages documentation and performance of biomarker assays conducted at CROs, ensures timely delivery of high-quality biomarker data, and supports CRO audits, • Ensures timely collection kit preparation and sample testing database builds including review of required documentation, • Works with Clinical Operations and CRO to prepare for site activations including preparation of training materials, • Manages collection kit logistics, sample inventory, and sample testing at CROs; tracks and follows up on discrepancies and missing information, • Coordinates shipping and testing scheduling with central lab or 3rd party vendors, • Contributes to data transfer specifications review and implementation, • Assist the internal biomarker laboratory with sample shipping and receiving, • Contributes to translational logistics meetings Requirements: Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, and efficient. Excellent communication, project management and interpersonal skills. Able to develop important relationships with key internal stakeholders and external entities. • Bachelors or Master's degree in biology, immunology, or related fields and/or project management experience is required with a minimum of 6 - 8 years experience within the biotechnology or pharmaceutical industry, • Demonstrated experience of managing biomarker sample operation of clinical trials, working with CROs to execute biomarker study plan., • Excellent communication skills, verbal and written, • Understanding and experience with drug development and clinical trial process Competencies • Time Management, • Risk Management, • Operations Management, • Finance, • Business Planning, • Implementing Plans, • Analysis and Reporting, • Negotiation Attributes • Honesty/Integrity, • Communication skills, • Self-starter, • Forward thinking, • Creative/imaginative, • Confident, • Self-controlled, • Intuitive, • Positive, • Committed, • Ambitious/driven, • Agile, • Collaborative, • Transparent In addition to a great culture, we offer: • A beautiful facility, • An entrepreneurial, highly collaborative, and innovative environment, • Comprehensive benefits, including:, • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $130,000 - $142,000. Exact compensation may vary based on skills and experience.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Senior Director of Quality provides strategic and operational leadership for all quality activities supporting Capricor’s clinical-stage and advancing commercial-stage organization. This role has full accountability for the design, execution, and continuous improvement of the Quality Management System (QMS) to ensure sustained regulatory compliance, inspection readiness, and robust quality oversight across development, manufacturing (including cell therapy production), and potential commercialization of Deramiocel and StealthX™-based programs. The Senior Director partners closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to enable late-stage development, BLA submissions and responses (including addressing any quality-related aspects of the Deramiocel pathway), commercial readiness, and scalable growth while embedding a proactive, risk-based quality culture across the enterprise.Responsibilities The Senior Director, Quality will provide strategic vision and operational direction for the Quality organization to ensure all programs meet the highest standards of safety, efficacy, and regulatory compliance. Quality Strategy & Leadership • Define and execute the enterprise quality strategy aligned with late-stage clinical development, BLA/regulatory submissions, potential commercial launch, and post-approval lifecycle management for cell and exosome-based therapies., • Serve as the senior Quality leader and strategic advisor to executive and operations management on compliance matters, inspection readiness, quality risk management, and GxP expectations in a biotech environment., • Establish and reinforce a strong quality culture emphasizing accountability, data integrity, continuous improvement, and risk-based decision-making throughout the organization. Enterprise Quality Systems, • Own and continuously enhance the enterprise QMS to support clinical, manufacturing, and commercial operations, including Document Control and Change Management, Deviations/Investigations/CAPA, Training and Qualification, Data Integrity and Records Management, and other core quality processes., • Ensure quality systems are phase-appropriate, scalable, efficient, and fully aligned with FDA GMP regulations (21 CFR Parts 210/211, 820, and biologics-specific guidance), ICH guidelines, ISO standards, and global expectations for advanced therapies., • Lead QMS readiness and optimization for commercialization, pre-approval inspections (PAIs), post-approval commitments, and lifecycle management of Deramiocel and future products. Regulatory Compliance & Inspection Readiness, • Ensure ongoing compliance with FDA, GMP, and applicable global regulations for clinical trials, manufacturing, and potential commercial activities, including cell therapy and exosome platforms., • Lead preparation for, management of, and response to regulatory inspections (including PAIs), partner audits, and health authority interactions; act as the primary Quality representative during agency engagements and inspections., • Support quality-related aspects of regulatory submissions, responses to information requests, and commitments (e.g., contributing to BLA updates addressing any quality/CMC items). Clinical, Manufacturing & Commercial Quality Oversight, • Provide comprehensive quality oversight for clinical quality assurance, including GCP compliance and support for ongoing trials such as HOPE-3 extensions or related activities., • Oversee quality support for manufacturing, testing, process validation, technology transfer, comparability studies, and supply chain activities for late-stage and commercial products (e.g., Deramiocel cell therapy production)., • Ensure timely and effective resolution of quality events, deviations, CAPAs, complaints, and out-of-specification results, with appropriate escalation, root cause analysis, and management visibility., • Support commercial readiness activities, including product release processes, distribution oversight, post-market quality monitoring, and pharmacovigilance integration as applicable. Cross-Functional Partnership, • Collaborate closely with Clinical, Regulatory Affairs, CMC/Process Development, Manufacturing, Supply Chain, Quality Control, and Commercial teams to integrate quality principles throughout the product lifecycle and enable efficient, compliant decision-making., • Provide risk-based quality guidance to support regulatory submissions, responses, and commitments while balancing compliance with operational agility in a fast-paced biotech setting. Quality Metrics & Continuous Improvement, • Establish, monitor, and report quality KPIs, trends, risk indicators, and compliance metrics to senior leadership and the Quality Management Review., • Drive continuous improvement initiatives, including process optimizations, lessons learned from inspections/audits, and enhancements to strengthen compliance maturity, operational efficiency, and inspection outcomes., • Use data analytics and trending to proactively identify, assess, and mitigate quality risks across the portfolio. People Leadership, • Build, lead, and mentor a high-performing QA and Quality Systems organization; develop talent, succession plans, and training programs to support organizational scaling and commercialization milestones., • Foster a collaborative, accountable, and inspection-ready mindset across the quality team and broader company.Requirements, • Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred., • 12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments, with significant focus on biologics, cell therapies, or advanced therapy medicinal products., • 7+ years of senior leadership experience with direct ownership and oversight of enterprise Quality Management Systems in a growing organization., • Hands-on experience supporting late-stage clinical programs, BLA submissions, pre-approval inspections (PAIs), and commercial readiness/launch activities for regenerative medicine or biologics products., • Deep knowledge of FDA regulations (including 21 CFR Parts 210/211, 820, biologics-specific guidance), GMP, ICH guidelines (Q8-Q12, etc.), and global standards relevant to cell and exosome therapies., • Demonstrated success leading regulatory inspections (PAIs, routine GMP inspections), responding to findings, and maintaining inspection readiness in dynamic settings., • Proven ability to scale QMS and quality organizations in a rapidly growing biotech company preparing for commercialization., • Strong executive presence with the ability to influence, collaborate with, and advise cross-functional teams and senior leadership., • Excellent communication, problem-solving, decision-making, and strategic thinking skills.Work Environment / Physical Demands, • Office-based with routine presence in GMP manufacturing and laboratory environments to support oversight, audits, inspections, and quality activities., • Extended periods of computer use for documentation review, data analysis, metrics reporting, and quality system management., • Occasional lifting of office or light materials up to 10 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Supply Chain Manager Location: Onsite - Atlanta, or San Diego Salary Range: $80,000 - $120,000 Job Overview The Supply Chain Manager oversees supply chain and logistics operations to ensure efficiency, productivity, and compliance within the pharmaceutical manufacturing industry. This role involves developing strategies, monitoring performance, and implementing policies to optimize processes, reduce costs, and align supply chain activities with company objectives and regulatory standards. Key Responsibilities • Strategic Planning: Design and implement supply chain strategies to meet company goals, forecast demand, and adapt to market changes., • Operations Management: Oversee procurement, production, warehousing, and distribution, ensuring seamless operations and optimized workflows., • Vendor Relations: Manage supplier relationships, negotiate contracts, and evaluate performance for quality and cost-effectiveness., • Inventory & Demand: Maintain optimal inventory levels, implement control techniques, and align production with customer trends., • Logistics: Coordinate transportation and work with third-party logistics (3PL) providers to ensure timely deliveries., • Cost Management: Monitor costs, create budgets, and implement savings strategies while maintaining quality standards., • Data Analysis: Analyze supply chain performance metrics and recommend process improvements., • Risk Management: Identify risks, ensure regulatory compliance, and enforce health and safety policies. Education & Experience: • Bachelor’s degree in Supply Chain, Logistics, Business, or related field., • Strong knowledge of supply chain processes, logistics, compliance, and quality assurance., • Proficiency in ERP and supply chain software (e.g., SAP, Oracle)., • Excellent organizational, project management, and leadership abilities., • Advanced Education & Certifications: Master’s degree or certifications such as CPIM, CSCP, or CLTD., • Industry & Regulatory Knowledge: Familiarity with FDA, GMP, and ISO 13485 regulations. Experience in global logistics and applying lean supply chain principles., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job Description On-site: Poseida location in San Diego, CA. About Us • Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases., • Our goal is to deliver potential single-treatment cures for patients in need. Position Summary • The Quality organization is seeking an experienced Senior Data Integrity Consultant to join our team in San Diego, CA. In this on-site contracted role, you will be integral to the deployment and oversight of the site's Data Integrity (DI) program while providing expert Computer System Validation (CSV) leadership., • Reporting directly to the Site Quality Head, you will provide independent Quality oversight for all computerized systems, the Quality Management System (QMS), and associated paper-based systems., • This role focuses on Quality Governance—ensuring that all data generated within laboratory, manufacturing, and quality environments is protected, attributable, accurate, and compliant with global regulatory expectations., • You will act as the primary Quality voice for Data Integrity, ensuring technical and procedural controls are not only in place but are functioning effectively to meet company and international standards. Key Responsibilities • Data Integrity Program Leadership, • Lead the deployment, enhancement, and effective implementation of the site's Data Integrity program., • Conduct and execute gap assessments of data integrity practices, identifying risks and developing comprehensive site mitigation plans., • Ensure the Quality System satisfies compliance requirements associated with:, • Data integrity regulations (FDA 21 CFR Part 11/211/820, EU Annex 11, EudraLex Volume 4), • Audit trail review and data governance, • Data quality, backup, recovery, and security controls, • Act as the primary Quality Assurance voice for DI standards, ensuring strict alignment with global quality expectations, • Provide expert QA oversight during the development of Solution Development Lifecycle (SDLC) documents (URS, Design Specs, Test Plans) to ensure DI and ALCOA+ principles are embedded at the architecture level., • Audit and approve the implementation of engineering controls, including audit trail configurations, restricted user access, and secure data mapping., • Validation & Computer Systems Assurance, • Author, review, and approve critical validation deliverables, including:, • Validation Plans, Risk Assessments, and User Requirements (URS), • Configuration Specifications, Test Scripts (IQ/OQ/PQ), • Validation Summary Reports and Periodic System Reviews, • Perform requalification of existing computer systems and support periodic reviews to maintain a validated state., • Act as the Quality Lead for project teams, guiding the implementation of validation, security, and compliance deliverables throughout the system lifecycle., • Oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release and update., • Support evaluation and gap assessments of legacy systems for technical integration and remediation planning., • Operational Compliance & Audit Readiness, • Lead and execute:, • Periodic System Reviews (PSR): Evaluating the ongoing "state of control" and effectiveness of the system's data lifecycle., • User Account Reviews (UAR): Ensuring strict segregation of duties and appropriate GxP access levels., • Change Control Oversight:, • Leading Quality impact assessments to ensure changes do not compromise the validated state or data reliability., • Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans., • Apply risk management processes to identify, mitigate, and escalate critical compliance findings or security risks to leadership., • Prepare management reports regarding compliance operations, project progress, and the overall validated state of site systems., • Continuous Improvement & Collaboration, • Drive the enhancement of Quality Compliance operating procedures to bridge gaps between local manufacturing standards and global quality expectations., • Interface between local site manufacturing quality standards and global standards to ensure a unified compliance posture., • Act as a high-level consultant to technical SMEs, providing the "Quality lens" on complex data flow and system integration challenges., • Align daily actions with department goals and company culture, actively promoting teamwork across all functions with a patient-first mindset. Qualifications • Education & Experience, • Education: Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered). Experience: • Minimum of 8+ years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred), with a focus on Data Integrity, Computer System Validation, and Quality Compliance. Regulatory Knowledge • Expert understanding of:, • FDA 21 CFR Part 11, 210/211, and 820, • EU EudraLex Volume 4 (Annex 11 and Chapter 4), • GAMP 5 and risk-based validation approaches, • ALCOA+ principles and data governance frameworks Technical Skills • Strong knowledge of Quality Management Systems in a cGxP manufacturing environment., • Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training., • Hands-on experience with Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), and laboratory/manufacturing systems., • Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word). Competencies • Exceptional written and verbal communication skills, with the ability to author and revise SOPs, work instructions, and validation documents., • Strong attention to detail and ability to manage multiple projects simultaneously in a fluid, dynamic, and fast-paced environment., • Proven ability to work independently, within prescribed guidelines, or as part of a collaborative team., • Experience developing training materials and delivering training to employees on DI and CSV topics., • Ability to lift up to 20 pounds as needed. The hiring range for this position is $85 to $92.20 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class. #ZR

Job DescriptionAbout the role: The Quality Assurance (QA) Specialist is responsible for supporting quality planning and ensuring compliance across production and operational processes within a regulated environment. This role works closely with manufacturing, engineering, and cross-functional teams to establish and maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. The QA Specialist oversees quality processes throughout the product lifecycle, including reviewing and approving validation and quality documentation, managing deviations, CAPAs, and change controls, and ensuring that production activities meet defined quality standards. The role also supports internal and external audits, participates in vendor qualification activities, and helps maintain compliance with regulatory and industry requirements. In addition, the position contributes to continuous improvement initiatives by monitoring quality metrics, supporting LEAN initiatives, and providing guidance and training on quality processes and compliance. The ideal candidate is detail-oriented, collaborative, and experienced in quality assurance within regulated manufacturing or life sciences environments, with a strong ability to ensure quality is built into planning, production, and operational workflows. Key Responsibilities: • Ensure compliance with applicable standards and regulations (ISO 9001, GAMP 5, EU GMP Annex 11, 21 CFR Part 11)., • Review and approve validation documentation (e.g., URS, FRS, test protocols, test scripts)., • Conduct and support internal and external audits, including regulatory inspections., • Develop, implement, and maintain QA policies, procedures, and SOPs., • Perform risk assessments and support risk-based decision-making., • Monitor and report on quality metrics and KPIs., • Provide training and guidance on quality and compliance topics to cross-functional teams., • Manage deviations, CAPAs, change controls, and other quality records., • Participate in vendor qualification and software supplier audits., • Stay current with regulatory developments and industry best practices., • Minimum 5 years of experience in QA within a regulated software development environment., • Experience working with LEAN, • Strong knowledge of ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11., • Experience with validation of computerized systems and software quality assurance., • Excellent understanding of SDLC and software testing methodologies., • Strong analytical, problem-solving, and communication skills., • Ability to work independently and collaboratively in a fast-paced environment., • Bachelor’s or master’s degree in Life Sciences, Computer Science, Engineering, or related field., • Experience with electronic quality management systems (eQMS)., • Familiarity with Agile and DevOps environments., • Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) is a plus. Biosero provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. In addition, Biosero complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Biosero is committed to diversity and inclusion. We seek individuals from all backgrounds and appreciate and celebrate the diversity of our growing team. Powered by JazzHR 30K9e5ebwk

Job DescriptionDescription: SUMMARY Under general supervision, the Senior Manufacturing Associate, Downstream, will perform routine manufacturing activities in GMP manufacturing areas including purification and the associated sub-processes/ preparation. Operations will be performed according to Standard Operating Procedures (SOPs) and batch records. Perform manufacturing steps, execute routine batch records, and revise documents such as batch records and SOPs as needed. Drives projects and assignments and provides mentorship to associates. Flexible shift schedule and overtime may be required. JOB RESPONSIBILITIES Technical: ? Perform moderately complex tasks using defined protocols or procedures which contribute to the achievement of project milestones. ? Perform GMP manufacturing activities in assigned areas. ? Set-up, operate, maintain and clean downstream bioprocessing equipment, which includes but is not limited to chromatography systems, UF/DF and Viral filtration skids and mixers. ? Perform basic troubleshooting of bioprocess equipment. ? Perform manual cleaning and sterilization of manufacturing areas, parts and components. Compliance: ? Follow Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), plant safety guidelines and other established procedures during the manufacturing process to produce quality products. ? Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the manufacturing Good Documentation Practices (GDP). ? Draft and revise SOPs and batch records. Teamwork and Communication: ? Participate in regularly scheduled team meetings to discuss ideas, troubleshoot issues, go over lessons learned and identify future projects or tasks. ? May provide mentoring and coaching to colleagues, team members, or those with similar or less experience ? Act as Lead when Specialist/Supervisor is unavailable. ? Address production issues and report any compliance related concerns to supervisor and/or management as soon as possible. ? Fosters teamwork and is expected to suggest project improvements. JOB REQUIREMENTS Education and Experience ? Advanced degree in life sciences or related discipline with 3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. ? Bachelor's degree with 6 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. ? High School Diploma/GED with 8 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. Knowledge, Skills and Abilities: ? Downstream/Purification experience and skills in Protein Chromatography, TFF, Depth Filtration, Viral Filtration, Bulk Drug Substance Formulation, and Final Filtration. Aseptic Sampling of process pools and buffers. Buffer Preparation, Tubing assemblies and Autoclaving Operations. ? Knowledge of UNICORN and Common Control Platform (CCP) Software is preferred. ? Fundamental knowledge of current biologics regulations and cGMP for drug substance operation. ? Proficient with Microsoft Word and Excel. ? Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions. ? Demonstrated ability to follow and document activities in written procedures and/or logbooks. ? Detail-oriented, strong team player. ? Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders. Requirements:

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Quality Control Associate II, Controls will support the development, qualification, and lifecycle management of analytical control materials used in QC assays. This role will be responsible for generating and maintaining positive and negative controls, performing analytical studies to evaluate assay performance, and supporting troubleshooting and optimization of analytical methods used in QC testing. This position plays an important role in ensuring the reliability and consistency of QC assays by supporting the generation, characterization, and maintenance of assay controls. The individual will work closely with QC scientists and cross-functional teams to support assay performance monitoring and continuous improvement of analytical methods used across Capricor’s therapeutic programs. Responsibilities • Generate, prepare, and maintain positive and negative control materials used in QC analytical assays., • Support the qualification and characterization of control materials to ensure suitability for routine QC testing., • Execute analytical assays to support control evaluation, assay troubleshooting, and assay optimization studies., • Perform laboratory activities related to control generation, characterization, and assay performance evaluation., • Maintain inventory, traceability, and documentation of assay control materials used across QC testing programs., • Analyze experimental data, summarize results, and document findings in accordance with GMP and data integrity requirements., • Document all laboratory work in GMP-compliant systems including laboratory notebooks, controlled forms, and electronic records., • Support preparation and maintenance of technical documentation including study protocols, reports, SOP updates, and control qualification records., • Assist with investigations related to assay performance including deviations, OOS/OOT events, and atypical assay results., • Collaborate with QC scientists and cross-functional teams including Analytical Development, Process Development, Manufacturing, and Quality to support assay readiness and continuous improvement initiatives., • Manage multiple laboratory assignments and testing priorities to meet project timelines and QC operational needs., • Perform additional QC duties as assigned. Required Qualifications (Must‑Haves), • Bachelor’s degree in Biological Sciences, Biochemistry, Molecular Biology, or a related discipline., • 2+ years of laboratory experience in biotechnology, pharmaceutical, or GMP-regulated environments., • Hands-on experience performing analytical assays such as ELISA, PCR/qPCR, flow cytometry, or other biochemical or cell-based assays., • Experience preparing or maintaining assay controls or reference materials., • Strong laboratory documentation practices and familiarity with GMP and data integrity expectations., • Ability to analyze data and communicate findings clearly., • Ability to work independently and manage multiple assignments in a laboratory environment., • Strong organizational and time management skills. Preferred Qualifications (Nice‑to‑Haves), • Experience supporting analytical studies related to assay performance or assay optimization., • Experience working with mammalian cell culture or cell-based assays., • Experience supporting method qualification or assay performance monitoring activities., • Experience supporting deviations, investigations, or technical reports in regulated environments., • Experience working with cell therapy, biologics, or exosome-based products. Work Environment & Physical Requirements, • Laboratory-based role requiring routine bench work., • Work involves analytical instrumentation, laboratory documentation, and computer-based data analysis., • Ability to lift up to 20 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCompany Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to , and follow us on X or LinkedIn. Reporting to the Senior Vice President of Quality, the Sr. Director of Quality will lead provide quality oversight of clinical development and manufacturing programs. This individual will lead the Chemistry, Manufacturing, and Controls (CMC) QA team and provide end-to-end development to manufacturing support for clinical stage programs and will develop systems to commercialize late-stage assets. This position will design, develop, and implement clinical and commercial quality strategies to ensure appropriate compliance to applicable regulatory regulations. The successful candidate will work closely with Technical Operations, Regulatory Affairs, and third-party Contract Development and Manufacturing Organizations (CDMOs) and will be responsible for all levels of studies, ranging from simple to complex and requires an in-depth understanding of GMPs, global Health Authority requirements, program management, quality systems, validation, and data integrity. Strong cross-functional team leadership and project management skills are essential requirements of the role. Job Description • Ensure compliance with all applicable local and global drug regulations., • Oversee Quality CMC functions with oversight and authority over batch disposition, manufacturing, packaging, labeling and testing activities to ensure product quality and timely release of materials and products., • Provide hands-on leadership to effectively facilitate quality functions related to batch disposition, investigations, process and analytical data review, supply distribution and risk management., • Serve as a point of contact for complex or high-risk quality issues and decisions., • Identify and manage quality risks across the product life cycle, recommend and support mitigation strategies., • Operate closely with ORIC technical operations team, Contract Manufacturing Organizations (CMOs), contract testing laboratories, and distribution sites to facilitate quality review of process/analytical data and reports, ensuring technical rigor and phase appropriate compliance to support program decisions., • Work cross-functionally with Regulatory Affairs to ensure timely and accurate review of submissions., • Operates closely with clinical program teams and serves as an active participant in clinical development meetings ensuring continuous quality support., • Develop performance-based quality metrics and trend analyses to drive continuous improvement., • Perform and present Annual Product Reviews for late-stage programs., • Lead, mentor and develop a high-performing Quality team effectively scaling the team to support clinical into commercial programs., • Serve as Chair or primary Quality member in various governance committees including ORIC’s Stability Review Board, Material Review Board and Change Review Board, • Represent ORIC Quality in CDMO meetings, regulatory authority interactions, strategic leadership meetings as needed., • Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies, workflows, and priorities in response to changing business needs, technologies, and stakeholder expectations., • Develop new functional, late phase, commercial ready SOPs, Policies/Plans as necessary.Qualifications, • Bachelor’s or Master’s degree in Chemistry, Biology, or a related scientific discipline, • 15+ years of relevant experience in Quality Assurance and/or Quality Control in the pharmaceutical industry., • 7+ years of prior senior leadership experience., • Deep hands-on knowledge in ICH, GMP, and regulatory guidance relevant to new drug development and commercialization. Experience with preparing for commercial stage operations and regulatory interactions preferred., • Experience over a broad set of Quality Assurance functions with extensive knowledge of industry best practices and trends., • Ability to understand business objectives and how they translate into quality priorities., • Demonstrated ability to develop a vision for Quality functions as it transitions through the phases of drug development to commercialization., • Demonstrated success in working with and managing CDMOs and external partners using succinct and thorough communication skills., • Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work., • Demonstrated initiative, ownership, problem identification, problem solving, and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met., • Results driven, collaborative leader with proven ability to perform in a fast-paced environment with a high attention to detail and demonstrated ability to manage and prioritize multiple competing tasks, • Excellent verbal and written communication skills, with the ability to build productive long-term team relationships at all levels of supplier organizations, including with senior executives, • Skilled at managing autonomous, high-performing professionals who value flexibility, while ensuring alignment, collaboration, and delivery of results. Additional Information The anticipated salary range for candidates who will work on-site at our San Diego location is between $220,000-$270,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead is seeking an experienced Senior Contracts Analyst or Contracts Manager to join its legal team in Pasadena, CA. Reporting to the Assistant General Counsel, the Senior Contracts Analyst/Contracts Manager will evaluate, draft and negotiate company contracts on behalf of Arrowhead. The ideal candidate will have excellent writing and negotiating skills, and will be detail oriented, responsive, tech savvy, quick to think on their feet, and be comfortable with making decisions independently based on an analysis of risk. The ideal candidate should be able to see their function within the big picture of Arrowhead's business, and must be comfortable working in a fast-paced environment where contracts need to be negotiated quickly and efficiently. Candidates should have 3+ (for Senior Contracts Analyst) or 5+ (for Contracts Manager) years of contract negotiation experience, preferably within the biotech or pharmaceutical industry, and should have a firm understanding of contract documents with an ability to identify and quickly analyze the importance and potential risks involved with negotiated terms. This role is full time onsite, 5 days a week in San Diego, CA. Responsibilities • Draft, negotiate and review appropriate contract documents to ensure their reasonableness and accuracy, and to ensure they include sufficient timeframes and deliverables; identify and resolve clauses adverse to Arrowhead's interests, • Assist in the management of Arrowhead's contracting system, including ensuring that contract requests and assignments are properly entered and tracked in the system, • Negotiate contract terms while ensuring that projects remain within established corporate parameters, • Communicate with internal and external stakeholders regarding contracts, • Write and/or edit contract communications and notices, • Assist with other general legal matters, as appropriate, • Be able to integrate and balance big-picture concerns with day-to-day activities, • Minimum of 3 years (for Senior Contract Analyst) or 5 years (for Contracts Manager) prior experience negotiating a large volume of contracts., • Possesses superior negotiation skills, • Excellent written and oral communication skills, with a keen eye for details and nuances, • Strong analytical ability, critical and strategic thinking skills with the ability to apply information to other related or similar situations, and project management skills to ensure appropriate execution of corporate goals, • Experience coordinating with internal clients to understand and help them meet their needs, • Bachelor's degree in a business or biotechnology-related field or equivalent relevant experience, • Pharmaceutical or biotech experience, • Experience with clinical trial agreements, • Senior Analyst: $110,000 - $125,000 Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Director, Quality Assurance & Quality Systems will lead and support quality assurance and quality systems activities for Capricor's clinical and commercial-stage biotechnology operations. The role advances the company's Quality Management System, drives inspection readiness, and ensures quality processes are scalable, compliant, and aligned with late-stage development and commercial launch. The ideal candidate brings hands-on QA and Quality Systems experience, deep knowledge of GMP and FDA requirements, and a proven ability to partner cross-functionally to build a proactive, risk-based quality culture. Responsibilities Quality Assurance & Quality Systems Leadership • Lead and manage the QA/QS team, ensuring alignment with company objectives and regulatory standards, • Develop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other relevant regulatory bodies, • Oversee the entire quality systems infrastructure, including Standard Operating Procedures (SOPs), batch records, specifications, and validation protocols, • Manage document lifecycle management ensuring version control, approval workflows, and archival in compliance with regulatory requirements, • Establish and enforce quality assurance policies and procedures across all operational departments, • Support the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirements, • Ensure timely resolution of quality-related issues, including non-conformances, deviations, and CAPA (Corrective and Preventive Actions), • Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs, supply chain, etc.) to ensure product quality throughout the entire lifecycle, • Partner with Regulatory Affairs to support CMC sections of regulatory submissions (IND, BLA, NDA), • Lead continuous improvement initiatives leveraging methodologies to enhance product quality, manufacturing processes, and operational efficiency, • Provide leadership in Quality Risk Management (QRM), including identification, assessment, and mitigation of quality risks using ICH Q9 principles, • Prepare and present quality performance metrics, trending analysis, and reports to senior management and board of directors, • Bachelor's degree in Life Sciences, Engineering, or a related field (Master's degree preferred), • 10+ years of progressive experience in Quality Assurance and Quality Systems, with at least 5 years in a leadership role within a regulated industry (pharmaceutical, biotechnology, or medical devices), • Strong knowledge of regulatory requirements, including FDA, GMP, ICH guidelines, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, and 1271, • Demonstrated expertise in Quality Management Systems (QMS) design, implementation, and maintenance, • Proven experience with electronic quality systems (eQMS) platforms (e.g., Veeva, MasterControl, TrackWise, or similar), • Proven experience leading quality assurance and quality systems teams and managing cross-functional collaborations, • Demonstrated ability to drive process improvements and manage complex quality systems in dynamic environments, • Excellent problem-solving, analytical, and decision-making skills, • Strong written and verbal communication skills, with the ability to interact with senior leadership, regulatory agencies, and external stakeholders, • Experience in preparing and presenting reports and metrics to senior management and board members, • Strong leadership and interpersonal skills, with the ability to mentor and guide teams towards excellence, • Ability to work effectively in a fast-paced, entrepreneurial environment with changing priorities Work Environment / Physical Demands, • Primarily office-based with required time in GMP spaces addressing quality management and audits., • Requires prolonged periods of computer use for documentation, data analysis, and report generation related to quality processes., • May involve lifting office materials or equipment up to 10 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director, Operations Network and Strategy is a member of a team charged with ownership of end-to-end supply chain for Arrowhead products. This individual develops and implements strategies for Arrowhead's operational network, focusing on areas like supply chain, distribution, or pathways to support a growing clinical pipeline and commercial market portfolio. This role may lead cross-functional teams to ensure operational efficiency, analyze performance data, set goals, and manage budgets to align with the overall business strategy. This position works closely with other departments to mitigate risks within global operations, identify process improvements, and facilitate network expansion opportunities. This role is based in onsite with an expectation to be in the office five days a week. Responsibilities Network Strategy & Design • Lead development of end-to-end operations network strategy aligned with enterprise growth objectives., • Design and optimize manufacturing, distribution, and supply network footprint (internal and external)., • Conduct scenario modeling to evaluate capacity expansion, site selection, outsourcing, nearshoring, and risk mitigation strategies., • Build and maintain advanced network models to support demand growth, product lifecycle changes, and geographic expansion., • Evaluate trade-offs across cost, service, resilience, sustainability, and risk., • Lead cross-functional S&OP/S&OE inputs related to network capacity and constraints., • Identify and lead high-impact cost, productivity, and service improvement initiatives., • Support make-vs-buy decisions and strategic supplier partnerships., • Drive network resilience planning, including dual sourcing, inventory strategy, and contingency planning., • Develop business cases for capital investments, site expansions, and strategic initiatives., • Quantify financial impact of network decisions (NPV, IRR, cost-to-serve analysis)., • Serve as a trusted advisor to senior leadership on operations strategy., • Present recommendations to executive leadership and Board-level stakeholders (as applicable)., • BS in Business Administration, Supply Chain/Logistics, Engineering, or other field related to the essential duties of this role., • 10+ years of relevant industry experience (7+ years in fast paced cGMP environments; 5+ years in a supply chain leadership role within the pharmaceutical industry.), • Exhibits excellent interpersonal communication, project management, collaboration, and analytical skills., • Strong MS Excel, PowerPoint, and Word skills., • Experience using Smartsheet or other work management software., • Proficient generating and presenting operational and financial metrics/KPI's., • Thorough understanding of and experience with some aspect of technical operations or CMC., • Demonstrated ability to effectively lead and influence cross-functional teams not under direct organizational reporting lines to communicate challenging goals and achieve objectives., • Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges., • Able to lead and coordinate large, complex strategy projects, with minimal direction Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MSdummyamp;T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance. We are actively seeking qualified candidates to join our talent pipeline for future client engagements. WORK LOCATION: Travel to client sites may be required up to 100% based on project phase and client needs. KEY RESPONSIBILITIES: (This list is not exhaustive and may be adjusted as needed.) • Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure., • Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews., • Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines., • Conduct field walkdowns, verify installation details, and ensure alignment with drawings, Pdummyamp;IDs, and GMP requirements., • Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection., • Partner with Operations and MSdummyamp;T to troubleshoot and resolve technical issues., • Collaborate with Maintenance and Reliability teams to address equipment performance gaps., • Support continuous improvement and process optimization initiatives., • Partner with QA, Validation, and MSdummyamp;T to maintain validated state of aseptic manufacturing processes., • Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1., • Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring., • Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports., • Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages., • Develop and execute commissioning and qualification protocols., • Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus., • Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines, • Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution., • Participate in project planning, scheduling, risk assessments, and milestone tracking. Education • Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing., • Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience., • Experience supporting commercial manufacturing operations in a regulated environment., • Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment., • Strong documentation and technical writing skills., • Ability to manage multiple priorities in a fast-paced environment., • Strong communication, analytical, and problem-solving skills. Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job Description Quality Manager - Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below. Immediate opening for a Quality Manager in San Diego, CA who possess: • Bachelor's Degree in a Scientific Discipline, • 5+ years of experience of direct pharmaceutical experience within QA & QC, • 2+ years of experience in a quality management role, • Familiarity with MasterControl and other relevant quality software Email resumes to and call 858.427.3668. FULL DESCRIPTION: The Site Quality Manager for the San Diego office is responsible for overseeing all aspects of quality related matters to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the Company's policies. The position requires a strong background in Quality Assurance (QA), chemistry, or microbiology, and experience in aseptic manufacturing. In addition to ensuring compliance with industry standards this role is responsible for leading quality improvement initiatives at the site and assuring that the site is capable of supplying products of high quality and value in a timely manner. The selected candidate will be responsible for: Quality Oversight: • Direct oversight of the Quality Assurance and Quality Control groups., • Manage all product release activities, ensuring compliance with regulatory standards., • Oversee the site supplier qualification and auditing program., • Ensure all aspects of the handling, manufacturing, and distribution of products at the site comply with the requirements of the corporate quality manual, relevant quality agreements or policies, and meet all relevant GMP regulatory and legislative requirements., • Provide General Management oversight for Quality at the site as directed by the Vice President, Quality, US., • Ensure local quality system and standard operating procedures are in place and that compliance with cGMP is maintained through training and audit., • Ensure high product quality through qualification and validation based on quality risk analysis., • Lead and report on various quality improvement projects within the quality, laboratory, and manufacturing areas., • Facilitate regulatory agency inspections (e.g. FDA) and customer audits., • Lead quality investigations on an as needed basis, providing expert analysis and resolution., • Author the Annual Product Quality Review (APQR) for the site., • Provide necessary QA oversight is provided during site media fills., • Offer input and support for site validation activities., • Assist in developing and monitoring of the site QA/QC financial budgets., • Ensure all components, drug product containers, closures, in-process materials, packaging material, labels, and drug products are released in accordance with the registered specifications., • Train and develop staff within QA and QC groups., • Provider leadership, direction, and support to QA department personnel, ensuring they are qualified, achieve a high level of competence, are motivated, and carry out their duties safely. The selected candidate will also possess: Education Requirements • Minimum of 5 years of direct pharmaceutical experience within QA, chemistry, or microbiology; with preference to aseptic manufacturing experience., • Proven leadership experience in a quality management role., • Proficient in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint, Access, Project)., • Familiarity with Adobe Acrobat., • Knowledge of QlikView, Master Control, MODA, and LIMS software programs. Salary Range: $125-130k/year For immediate and confidential consideration, please email your resume to and call 858.427.3668. More information can be found at Company DescriptionSimply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Job DescriptionCompany Description Eurofins Scientific is a network of independent companies providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With more than 20 U.S. locations, Eurofins Built Environment Testing offers Industrial Hygiene (IH) and Indoor Air Quality (IAQ) services to protect health in built environments. Clients include consultants, industry, real estate, healthcare, government, and homeowners. Services cover a wide range of tests, including asbestos (PLM/TEM), mold, bacteria, VOCs, allergens, Legionella, radon, lead, silica, and more. Job Description Eurofins Built Environment Testing is searching for an Mold/Asbestos Analyst in San Diego, CA. Eurofins invests in training our new hires and this position may require overnight travel for training. The Analyst primarily performs analysis of bulk samples using PLM for asbestos, and analysis of non-culturable surface and air samples for fungi. Analyst prepares and analyzes environmental samples according to scientific methodology in compliance with company Quality Assurance programs and SOP’s, and must be knowledgeable of both job-specific routine and complex analyses. The analyst validates and reviews data for accuracy, and enters laboratory data into the LIMS that ultimately generates required reports to clients. Schedules sample workload according to due dates and sample hold times, and must be knowledgeable of the job-specific laboratory testing equipment, requiring the exercise of discretion and judgment in its operation. Mold/Asbestos Analyst responsibilities include, but are not limited to, the following: • Prepare and analyze aerobiological and environmental samples for asbestos and fungi., • Accurately enters and reports analytical data using the LIMS, • Performs independent data reviews for other analysts’ work, • Performs analysis of reference materials, proficiency samples and other quality control samples as needed, • Maintains client service and provides technical support as needed, • Assists the QA manager in development, implementation and data collection of QA processes for the different analytical tests, • Performs confirmation of lab results as needed by client services personnel, • Performs and completes all analytical testing and Quality Assurance related tasks as needed, • Assists in pursuing, receiving and maintaining necessary laboratory accreditations, • Maintains and updates all necessary Training and QA documents onsite as necessary, • Coordinates and manages projects according to their rush status and due time for timely delivery, • Assists co-workers on analytical questions, as necessary, • Participates in Lean initiatives as needed, • Follows company policies and procedures and ensures that coworkers are doing the same, • Manages and maintains the inventory of re-sale supply items and laboratory consumables and takes necessary steps to re-order supplies as needed, • Manages and disposes analyzed samples as needed, • Provides training support for relevant analytical services (i.e. mycology, bacteriology, asbestos, ect) as needed, • Recommends and coordinates sample transfer as necessary, • Establishes and maintains laboratory stock culture and reference samples, • Performs root cause analysis and implements corrective actions for errors and issues as necessary, • Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory, as needed, • Routinely communicates available capacity to Regional Manager, • Supports other departments within the lab (mycology, asbestos, bacteriology, and other) when appropriate and as needed, • Other responsibilities as deemed necessary by the Supervisor/ManagerQualifications Basic Minimum Qualifications: • 1+ years of industry experience performing asbestos microscopy and/or performing spore trap and fungal direct exam and culture analysis highly preferred, • Bachelor’s degree in microbiology, biology, geology or a closely related science, • Authorization to work in the United States indefinitely without restriction or sponsorship, • Professional working proficiency in English is a requirement, including the ability to read, write and speak in English, • Academic and/or professional optical microscope experience, • 8 units of Microbiology courses preferred, • General regulatory requirements, • Knowledge of computers, spreadsheets, and databases, • Strong computer, scientific, and organizational skills Additional Information Compensation range: $22 - $27 per hour depending on experience and qualifications. Position is full-time, Monday - Friday, 8:00am - 4:30pm shift with overtime and possible weekends as needed. Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! At Eurofins, we believe sustainability is at the heart of everything we do. Guided by our vision to be the Global Leader in “Testing for Life,” our mission to contribute to a healthier and safer world, and our core values, we are building a strong foundation for Environmental, Social, and Governance (ESG) initiatives. Eurofins’ commitment to sustainability begins within our own companies through a shared responsibility to people and the planet. With climate change posing an imminent threat, Eurofins and its many companies recognize their duty to proactively reduce or offset the environmental impact of essential operations while also helping our clients do the same—serving as a true ESG Enabler. Find out more in our career page: Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2025, Eurofins generated total revenues of EUR 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Post-Marketing Product Quality Compliance Manager will oversee post-market product quality activities in compliance with FDA regulations and internal Quality System requirements. This role leads and develops a team responsible for product quality complaints, post-distribution quality monitoring, and the execution of quality-driven field actions, including recalls and market withdrawals. The manager provides strategic direction, coaching, and performance management to ensure timely, compliant, and effective execution of post-market quality processes while fostering a culture of quality and continuous improvement.Responsibilities * Post-Market Surveillance & Data Analysis • Manage the end-to-end product quality complaint process from intake through closure., • Assess complaints for product quality impact, GMP compliance risk, and field action triggers., • Trend and analyze post-market quality data to identify recurring or systemic issues., • Provide Quality oversight of vendors supporting complaint intake or triage., • Ensure accurate, complete, and timely complaint documentation., • Perform initial Quality assessments and ensure appropriate complaint classification., • Escalate potential adverse events to Pharmacovigilance per established procedures., • Escalate critical or high-risk quality issues in a timely manner., • Identify and assess potential recalls, market withdrawals, or corrections., • Lead quality-driven recalls, including regulatory notifications, documentation, and effectiveness checks., • Drive CAPAs resulting from post-market quality issues and verify effectiveness., • Maintain and improve SOPs related to complaints, post-market monitoring, recalls, and vendor oversight., • Oversee Internal Audit program and Inspection Readiness., • Act as a Quality SME during FDA inspections and audits., • Support preparation of inspection responses and supporting documentation related to post-market quality activities.Requirements, • Education: Bachelor’s degree in Life Sciences, Engineering, or a related field (Master’s preferred)., • Professional Experience: Minimum 7 years of experience in Quality within a regulated pharmaceutical, biologics, or cell therapy environment., • Leadership: 2 years of people management experience., • SME Knowledge: Hands-on experience with product complaints, post-market quality surveillance, and recalls or field actions., • External Oversight: Experience overseeing external vendors in a regulated Quality environment., • Regulatory Foundation: Strong knowledge of FDA Quality System and post-market requirements. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionDescription: Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as an approved drug for the treatment of cancers and immune-mediated inflammatory diseases. We are currently seeking a highly motivated, creative CMC formulation professional at associate director or director level to join our CMC team in San Diego. This candidate will report to the Executive Director and Head of CMC. This candidate is expected to work closely with Kumquat internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. This is a position with responsibility for formulation strategy design, process development and manufacturing. The ideal candidate will have an in-depth understanding in all aspects of oral solid dosage formulations and injectable formulations. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will have the opportunity to work on multiple programs within the company’s pipeline which comprises potentially first-in-class approaches & novel-novel targets. Role responsibilities • Understand the development candidate’s physicochemical properties and target product profile to evaluate formulation options and design phase appropriate formulations at different development stages., • Select external CRO/CDMO partners based on project needs and the external parties’ technical capabilities, quality system, and track records., • Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget., • Plan and oversee drug product process optimization, GMP manufacturing, packaging, labeling, stability testing activities., • Track process development/validation history and manage CMC drug product related documents in support of life cycle of quality improvement and regulatory filing/updates., • Work closely with a cross-functional team within and outside of the CMC department to align with key stakeholders (CMC, Clinical, Quality Assurance and Regulatory)., • Author and review CMC drug product related sections for regulatory filing and annual updates., • Stay current on industry trends and regulatory requirements to ensure delivery of quality products under cGMP environment., • Prepare and communicate research results in both oral and written format., • Supervise junior CMC Drug product team members., • Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence. Requirements:, • Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 10 years of industry experience (title for this position will be commensurate with the candidate’s experience and qualifications), • Highly familiar with current formulation principles and industry practices., • Extensive process development/ optimization, scale-up and process validation expertise, with emphasis on solid oral dosage forms., • Experience with injectable formulations and modern enabling technologies is a plus., • Track record of accomplishment in managing CMC drug product projects at early and late development stages., • Ability to enable external CRO/CDMO to achieve project goals on time and under budget., • Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment. Salary Description: $170k - $275k

Job DescriptionSummary A leading value-added mechanical contractor is seeking an experienced HVAC Estimator to support preconstruction and bidding efforts for complex commercial and industrial projects across Southern California. This role is responsible for producing accurate, competitive estimates from early design through fully developed documents and working closely with internal project teams and design partners. This position is best suited for someone who understands mechanical construction bidding, can work from incomplete documents, and is comfortable supporting design-build and design-assist work. Key Responsibilities * Review bid documents, drawings, specifications, and addenda * Attend pre-bid meetings and interface directly with clients and design teams * Perform quantity takeoffs, material pricing, equipment pricing, and subcontractor analysis * Size and lay out HVAC and plumbing systems from incomplete design documents * Prepare detailed estimates and proposals using Autobid or similar estimating software * Support design-assist and design-build efforts by working with engineers to meet budget targets * Coordinate with project management and CAD detailing teams during preconstruction * Evaluate safety, insurance, bonding, and labor considerations as part of bid strategy * Maintain organized estimating files, data, and historical pricing Project Experience Preferred * Healthcare and HCAI-regulated facilities * Hotels and hospitality * Student housing and higher education * Laboratories and clean rooms * Manufacturing, power plants, and cogeneration facilities * Pharmaceutical, microelectronics, and cGMP environments Qualifications * 3–5+ years of mechanical construction estimating experience * Strong knowledge of HVAC and plumbing systems * Ability to produce complete estimates from incomplete or conceptual documents * Proficient in MS Word, Excel, Outlook, Bluebeam * Experience with Autobid or similar on-screen estimating software preferred * Strong communication, organization, and time management skills * Ability to work independently with minimal supervision Compensation & Benefits * Competitive benefits package * Long-term opportunity with a stable and growing mechanical contractor

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. In this role, you will oversee the daily operations, maintenance, and repair of pharmaceutical and R&D manufacturing and facility systems, ensuring they operate in a validated state of control. You will manage programs and personnel, drive continuous improvements, and maintain compliance with GMP and regulatory standards while ensuring safe, reliable, and cost-effective facility operations. RESPONSIBILITIES * Maintain facilities and process equipment supporting Commercial and Clinical manufacturing, Research and Development, and related services. * Manage staff to support 24/7 operations, ensuring safe, reliable, and cost-effective usage. * Coach, guide, and direct the facility team, monitoring and assessing performance of maintenance personnel and contractors. * Leverage prior GMP knowledge and experience to present to FDA or other regulatory agencies. * Collaborate with teams to identify and implement continuous improvement opportunities for systems and processes. * Specify and recommend equipment modifications to enhance safety, reliability, and operability. * Communicate regularly with customers, partners, and stakeholders to share key developments, opportunities, and risks. * Manage operating status and outages for systems, facilities, and utilities to maximize uptime. * Develop and implement corrective action plans for facility system repairs, replacements, and modifications. * Ensure timely completion of maintenance work orders. * Track facilities expenditures and prepare the annual budget. * Foster a culture of inclusion, prioritizing safety and injury prevention. * Maintain compliance by updating maintenance and operations SOPs for improved scheduling and equipment uptime. * Perform additional assigned duties as needed. REQUIREMENTS * High School Diploma/GED or local equivalent required; Bachelor’s degree in a relevant field preferred. * 5-8 years of relevant maintenance experience required. * 2-4 years of managerial experience in pharmaceuticals, biotech, food processing, high-tech, or other heavily regulated industries required. * 2+ years of experience managing facilities under GMP regulatory compliance required. * Comprehensive knowledge of maintenance practices for equipment such as boilers, chillers, air handlers, HVAC systems, cooling towers, pure steam generators, Water for Injection systems, autoclaves, heat exchangers, security systems, electrical distribution, fire protection, clean-in-place systems, classified air systems, RODI systems, emergency generators, and fume exhaust systems. * Familiarity with pharmaceutical manufacturing equipment, including liquid filling machines, stoppering machines, capping machines, vial washers, and dehydrogenation ovens. * Ability to manage multiple responsibilities with strong self-motivation. * Capability to work independently and collaboratively in a team-oriented environment. * Trained in cGMP operations for pharmaceutical, biotechnology, or medical device manufacturing. * Knowledge of aseptic gowning and cleaning techniques. * Proficiency in managing after-hours responses and extended shifts to support planned or unplanned events. * Strong analytical, problem-solving, and communication skills. * Leadership skills to guide and coach teams effectively. Work Environment / Physical Demands: * Primarily facility-based, involving oversight of manufacturing and R&D systems, with tasks including maintenance, inspections, and documentation. * Requires accessing small spaces to assess mechanical issues and standing or walking for extended periods. * Involves prolonged periods of computer use for tracking expenditures, preparing budgets, and updating SOPs. * May require lifting up to 50 pounds. * May involve after-hours responses and extended shifts to support facility operations. * Occasional travel may be required for regulatory presentations or vendor interactions. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough. Come Work With Us!At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Locations: Boston, MA North Chicago, IL San Diego, CA This role will require regular on-site presence (3 - 4 days / week) at client site(s) About Zifo: Zifo is a leading global scientific informatics and digital solutions provider focused on transforming research and development for life sciences organizations. We partner with pharmaceutical, biotech, and agritech companies to drive R&D efficiency, ensure data integrity, and enable scientific innovation through process excellence and technology enablement. Position Overview: Zifo North America is seeking a Senior Scientific Business Systems Analyst (Senior BSA) to support strategic R&D initiatives for pharmaceutical, biotech, and related life sciences customers. This role is responsible for independently leading low-to-medium-complexity business analysis engagements while collaborating closely with customer stakeholders and Zifo’s global delivery teams. The Senior BSA plays a critical role in driving project success by translating scientific and business needs into actionable requirements, guiding informatics and data-driven solutions, and ensuring high-quality delivery across complex R&D environments. This position requires strong scientific domain expertise, consulting acumen, and hands-on experience delivering informatics and data projects in regulated and non-regulated research settings. Key Responsibilities Consulting & Business Analysis • Lead and execute business analysis activities across R&D-focused projects with minimal supervision., • Review and analyze existing business processes, systems, and data flows to identify gaps, risks, and improvement opportunities., • Conduct voice-of-the-customer sessions, stakeholder interviews, and workshops to elicit and prioritize requirements., • Perform gap analysis and define future-state process workflows, data models, and system interactions., • Develop and review core deliverables including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), workflows, implementation roadmaps, gap analysis reports, and training materials., • Evaluate industry trends and leading practices in scientific informatics to recommend optimized future-state solutions., • Support vendor evaluations and contribute to implementation strategies for small to mid-size life sciences organizations., • Manage one or more small projects or modules within larger programs, ensuring delivery on scope, schedule, and quality., • Perform project management activities including effort estimation, task planning, scheduling, and risk assessment., • Identify, track, and mitigate project risks; proactively address issues and escalate concerns when appropriate., • Monitor project progress and communicate clear, timely status updates to internal teams and customers., • Support and mentor junior Business Analysts by guiding deliverable development, planning, and execution., • Serve as a key point of contact with customers for delivery on assigned engagements, managing expectations related to process, quality, timelines, and outcomes., • Build strong working relationships with customer stakeholders, including manager-level contacts., • Proactively sense and address customer concerns before they escalate; collaborate with Solution and Delivery Managers on corrective actions., • Plan, track, and report billable effort accurately and on time., • Identify opportunities for Zifo to add value within customer organizations and surface potential follow-on engagements., • Demonstrate continuous learning in scientific domains, informatics platforms, and consulting methodologies., • Assist with internal training development and knowledge-sharing initiatives., • Mentor other analysts within global team, fostering collaboration and high performance. Qualifications: • Bachelor’s or Master’s degree in a relevant scientific discipline such as biology, chemistry, chem/bioinformatics among others, • 3-5 years of experience as a Business Analyst or similar role within an R&D organization., • Experience with informatics solution projects (e.g., ELN, LIMS implementations), • Familiarity with scientific workflows (e.g., bioanalysis, compound management, medicinal chemistry)and key data concepts within the life sciences industry and relevance to operational activities and enabling decision-making. CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The QC Specialist, Analytical supports the quality and compliance of cell therapy programs through a focus on data review, investigations, and quality systems. This role plays a key part in ensuring that QC methods, analytical data, and documentation meet cGMP requirements and regulatory expectations for clinical and commercial manufacturing. Working cross-functionally with Quality Assurance, Analytical Development, and Manufacturing, this position emphasizes technical writing, data analysis, and product quality oversight. While maintaining a strong understanding of laboratory operations, the role is not primarily focused on routine bench work. Responsibilities • Lead and support investigations related to deviations, OOS/OOT/invalid results, and CAPAs, ensuring thorough root cause analysis and clear documentation., • Review QC data, laboratory records, and analytical results to assess product impact and ensure compliance with cGMP standards., • Author and review SOPs, test methods, validation protocols/reports, and investigation summaries., • Perform data trending and analysis to identify variability, shifts, or emerging risks in QC and product quality data., • Support method lifecycle activities including qualification, validation, transfer, and periodic review in collaboration with Analytical Development., • Provide technical oversight of QC methods to ensure they remain scientifically sound and fit for purpose., • Contribute to change control activities and assess potential impact to product quality and method performance., • Support maintenance of product specifications, including acceptance criteria and scientific justification., • Participate in stability program activities, including data review and trending to support shelf-life determinations., • Ensure accurate, complete, and compliant GMP documentation in alignment with data integrity (ALCOA+) principles., • Support audits and regulatory inspections by preparing and reviewing technical documentation., • Collaborate cross-functionally with QA, Manufacturing, and external partners to support product quality objectives., • Contribute to quality risk assessments (ICH Q9), continuous improvement initiatives, and quality system enhancements.Required Qualifications (Must‑Haves), • Bachelor’s degree in Life Sciences, Biotechnology, or related field (advanced degree preferred)., • ~5–8+ years of experience in GMP Quality Control, Quality Assurance, or related function within biotech or pharmaceutical industry., • Strong knowledge of cGMP, FDA/EMA regulations, and ICH guidelines., • Experience with deviation investigations, OOS/OOT, CAPAs, and change control processes., • Strong technical writing, data analysis, and problem-solving skills., • Working knowledge of analytical methods such as flow cytometry, PCR, ELISA, and bioassays., • Excellent communication skills and ability to collaborate in a cross-functional environment., • High attention to detail and commitment to quality and compliance.Work Environment & Physical Requirements, • Primarily office-based with occasional presence in laboratory or manufacturing areas as needed., • Ability to sit or stand for extended periods and move throughout the facility., • Ability to gown and enter classified areas when required. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety. As an External Quality Operations Manager (EQOM), you’ll play a pivotal role in overseeing the quality performance of external manufacturing partners. Acting as the primary point of contact for these suppliers, you’ll ensure that every batch produced meets GMP/GDP requirements, aligns with Quality Technical Agreements, and upholds Sobi’s global quality standards. You’ll be the bridge between Sobi and its external network, driving compliance, collaboration, and continuous improvement to support reliable product supply and Sobi’s fast‑growing global footprint. This role offers the opportunity to work cross‑functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening Sobi’s commitment to delivering high‑quality medicines to patients worldwide. Key responsibilities: * Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO) * Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement. * Support release products to Markets * Support the External Service Provider (CMO) Qualification * Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier * Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product Quality performance * Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA. Assess the performance of the product and the process as per Sobi requirement * Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement * Ensure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements * Support that Quality Audits of the CMO are performed according to Sobi requirement and the QTA * Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization * Lead or act as Quality representative in projects related to CMO eg Tech Transfer, Launch * Assess and ensure CMO for Health Authorities (HAs) inspection readiness * Support HA inspections/audits of Sobi * Responsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy * Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally * Ensure the batch release as required Qualifications Required: * High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science * More than 5 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP) * More than 1 years of managing external quality oversight of CMOs * Curriculum is requested for evaluating the batch release qualification requirement * Fluently spoken and written English Desired: * More than 2 years of working in global operation environment with English as a main language * Proven experience of leading Quality KPI assessment and improvement at CMOs * Proven track record with FDA; EMEA or other Health Authorities * Strong understanding of risk assessment and risk management fundamentals / tools What You’ll Bring To thrive in this role, you’ll combine deep knowledge of GMP and GDP regulations with proven experience in quality oversight of Contract Manufacturing Organizations (CMOs). You’re confident operating in a global, fast‑moving environment, using your leadership and interpersonal skills to influence external partners and drive collaborative decisions. You naturally build strong relationships — both within Sobi and with CMOs — and you know how to balance compliance with practical solutions that keep supply moving. Highly organized and skilled in planning and prioritization, you coordinate multiple deliverables with precision. As a leader, you take pride in coaching and developing others, fostering a culture of accountability and high performance across the quality network. Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. The base salary range for this role is $130,000-$153,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to Know Your Rights

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Operations Associate II/III supports the execution of operational readiness activities across key functions, including Facilities and cross-functional operational programs. This role helps ensure day-to-day operations run smoothly by coordinating documentation, supporting operational projects, maintaining organized records, and assisting with employee onboarding and workplace logistics. The position partners closely with Operations, Facilities, IT, QA, Manufacturing, and EHS to support structured systems and processes that enable both GMP and non-GMP operations, as well as overall facility readiness. Responsibilities Operational Support • Support daily operational activities across Facilities and Operational Readiness programs, including vendor coordination and workplace operations., • Track operational tasks, action items, and project deliverables using project management tools (Smartsheet, SharePoint, etc.)., • Assist with coordination of operational meetings, vendor visits, and facility activities and escalate issues as needed., • Maintain organized operational documentation and records., • Assist in execution of capital projects, expansions, and buildouts., • Support organization of operational files, including safety documentation and compliance records., • Prepare reports or summaries related to operational activities when requested., • Assist with ad-hoc general operational projects and improvement initiatives as needed.Requirements, • Bachelor’s degree in industrial engineering, Operations Management, Business Administration, or related field preferred or equivalent combination of education and relevant operational experience., • 2+ years of experience supporting operations, facilities, EHS, or project coordination., • Strong organizational and documentation management skills, • Ability to coordinate multiple operational activities simultaneously, • Experience with project tracking tools (Smartsheet, Excel, SharePoint), • Strong communication and coordination skills, • Detail oriented with strong recordkeeping practices, • Ability to work cross-functionally with multiple departments, • Organization and process management, • Accountability and follow-through, • Operational coordination, • Communication and teamwork, • Problem solving and proactive supportPreferred Qualifications (Nice‑to‑Haves), • Biotech, pharmaceutical, or laboratory operations environment, • Experience supporting facility operations or infrastructure projects, • Familiarity with document control systems and audit readinessWork Environment & Physical Requirements, • Prolonged periods of desk work, including computer use and administrative tasks, • Frequent walking throughout office and facility spaces, including during project coordination and site activities, • Ability to lift and move items up to 20 pounds (e.g., office equipment, supplies, or materials), • Ability to bend, reach, and carry items as needed to support workplace setup and operational activities Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionFate Therapeutics is currently seeking a strategic and results-driven Senior Director, Supply Chain to lead end-to-end supply chain operations for our clinical programs. This role will oversee planning, procurement, warehousing and logistics, and global distribution, ensuring critical therapies reach patients on time. The successful candidate will drive cross-functional collaboration, process improvement, and data-driven solutions while leading a high-performing team. The ideal candidate has deep experience in GMP-regulated supply chains, a track record of strategic leadership, and a passion for optimizing operations in a fast-paced biotech environment. This is a full-time, exempt position located at our corporate headquarters in San Diego, California. Responsibilities * Lead end-to-end supply chain strategy and operations for Fate’s clinical assets, including planning, procurement, warehousing, and logistics. * Oversee day-to-day management of company’s supply chain, logistics and inventory levels to ensure continuity of supply while optimizing cost, quality, and delivery for internal and external stakeholder satisfaction. * Strong knowledge and experience with cGMP operations for pharmaceutical products, end- to-end supply chain forecasting and supporting global product launches * Lead and develop a high-performing procurement and supply chain team, driving effective supplier management, contract negotiations, procurement operations, and compliance with GxP and company policies. * Oversee forecasting, demand planning, supply strategy, packaging, labeling, and global distribution for clinical programs Phases 1–4. * Ensure availability of raw materials, consumables and materials to support GMP production and R&D activities and timelines. * Proactively identify and mitigate supply chain risks; ensure robust scenario planning and contingencies, and drive rapid resolution of supply disruptions, capacity constraints, or logistics challenges. * Collaborate with site leadership to drive outcomes as assigned and drive cross-functional triage, escalation, and problem-solving to unplanned events during supply chain processes. * Ensure supply chain procedures and teams are inspection and audit ready; can serve as the SME during audits. * Lead SOP development and governance for consistency, quality, and scalability. * Drive standardization and end-to-end process mapping to support scalability and operational maturity and to optimize speed and accuracy. * Champion digital transformation, continuous improvement, and data-driven initiatives, including shipment tracking, forecasting tools, supply visibility platforms, automation, and analytics. * Develop and implement standard planning processes, tools, and best practices for supply & demand modeling, and risk identification scenario planning. * Stay current on industry trends and developments in supply chain management, and make recommendations for incorporating new technologies and processes. * Foster a culture of continuous improvement through effective project management and identification of opportunities to drive efficiencies. * Develop industry standard data flows from demand development to production release supporting forecasting and budgeting efforts. * Establish and monitor Key Performance Indicators (KPIs) to focus the team on key priorities and oversee continuous improvement. * Oversee international shipments requiring customs paperwork for worldwide shipment of investigational products (IP) and ancillary supplies. Coordinate with international Qualified Person for release of IP for use. Qualifications * Bachelor’s or master’s degree with – 12+ years of relevant supply chain planning and management experience in biotech or pharmaceutical industry, including global experience. * Demonstrated success in clinical and commercial drug supply chain management. * Deep understanding of regulatory and technical influences and ability to assess business and financial implications of decisions. * Proven leadership experience building and developing high performing teams and guiding organizations during phases of rapid growth or transformation. * Proficiency in ERP software, specializing in end-to-end Planning, Purchasing, and Inventory Management processes * In-depth technical operations and quality knowledge as well as applied expertise in GMP and GDP regulated facilities. * Exemplary problem solving, interpersonal, and project management skills. * Experience managing external suppliers such as 3PL and logistics providers. * Proven record of meeting tight timelines and prioritizing workload within a dynamic organization. * Extensive knowledge of managing and shipping cold-chain products; knowledge of cryopreserved products a plus. * Self-motivated, collaborative leader who thrives in dynamic environments and is comfortable navigating complexity and ambiguity. Working Conditions & physical requirements * Travel may be required up to 20%. * Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. * May require lifting and/or moving up to 50 pounds. * May require working with hazardous materials. * Will require work in controlled and cGMP Manufacturing environments requiring special gowning. Compensation • The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location., • Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. ⚠️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud:- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.- We will only ask for personal information when applying for a position via our Careers page or thereafter.- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionDescription: The Director of Process Validation provides strategic and technical oversight of validation activities performed by external drug substance and drug product (injectables and solid oral dosage forms) manufacturing and testing partners. Operating within a virtual pharmaceutical model, this role ensures that all contract development and manufacturing organizations (CDMOs/CMOs) maintain compliant processes, equipment, utilities, cleaning procedures, and computerized systems in accordance with global cGMP requirements. This position focuses on governance, review, approval, and lifecycle management of validation deliverables rather than direct execution. The Director collaborates cross functionally with Quality, Analytical Chemistry, Supply Chain, External Manufacturing, and Regulatory Affairs to support technology transfers, commercial readiness, deviation management, and regulatory inspections. Essential Duties and Responsibilities The main responsibilities of this role include: • Provide technical oversight of process, equipment, utility, shipping and cleaning validation executed by external partners., • Review and approve validation master plans (VMPs), protocols, reports, and lifecycle documents generated by CDMOs., • Ensure outsourced activities meet internal standards, ICH guidelines, and global regulatory expectations (FDA, EMA, MHRA, etc.)., • Lead and/or evaluate validation risk assessments (FMEA, risk ranking, etc.) in collaboration with CDMOs., • Define validation acceptance criteria and critical parameters in alignment with QbD principles., • Ensure CDMOs apply sound scientific rationale, statistical approaches, and data integrity standards., • Oversee process validation activities performed at contract manufacturing sites., • Ensure CPPs and CQAs remain in a state of control throughout commercial production., • Support technology transfers to new manufacturing or testing sites, ensuring validation readiness., • Review and approve commissioning/qualification documents (URS, FAT/SAT summaries, IQ/OQ/PQ) produced by CDMOs., • Assess validation strategies for critical utilities (WFI/PW, HVAC, compressed gases) including sampling plans and qualification data., • Evaluate cleaning validation strategies, worst-case assessments, and verification data provided by the external site., • Ensure CDMOs follow GAMP 5 and Annex 11 for systems impacting product quality, batch documentation, or data integrity., • Review and approve documents including risk assessments, data integrity assessments, and validation reports., • Review validation deviations, atypical results, and investigations from manufacturing partners; provide technical justification and ensure CAPA effectiveness., • Evaluate validation impact assessments as part of change control initiated by CDMOs., • Perform periodic reviews of validation documentation to ensure ongoing cGMP compliance., • Participate in audits of contract manufacturers, labs, and service providers, as applicable, focused on validation and technical operations., • Prepare validation related content for regulatory submissions and inspections., • Help external partners address observations and implement sustainable remediation., • Serve as the technical operations validation SME in meetings with CDMOs, QA, Supply Chain, and Regulatory., • Support vendor governance processes, business reviews, and performance monitoring., • Other duties as assigned. Requirements: Education and Experience • Bachelor’s or Master’s degree in chemical or biomedical engineering, or other related life sciences discipline., • 10 years in validation within pharmaceuticals, biotech, or advanced therapies. Knowledge and Skills • Experience working with or inside CDMOs is strongly preferred., • Strong understanding of virtual manufacturing models and global CDMO oversight frameworks., • Demonstrated ability to influence without authority in outsourced environments., • Experience in aseptic/sterile manufacturing and tableting, of therapeutic peptides, small molecules, biologics, or high potency APIs., • Knowledge of validation-related processes, Six Sigma, Lean, etc., • Experience authoring regulatory submissions (e.g., Module 3 validation sections)., • Expertise in ICH Q7/Q8/Q9/Q10, EU Annex 11/15, FDA 21 CFR 210/211., • Understanding of QbD, risk-based validation, and CPV., • Capability to evaluate statistical approaches (e.g., process capability, sampling rationale)., • Strong communication and diplomatic negotiation skills with external partners., • Ability to analyze complex technical data and summarize risks clearly., • Highly organized, with the ability to manage multiple CDMO interfaces simultaneously. Travel Requirements Approximate travel: less than 20% of the time VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Salary Description $180,000.00 - $215,000.00 annual salary

Job DescriptionDescription: The Associate Director, Formulation Development, assists in the design and development of drug delivery systems, specifically for oral dosage forms and injectables to advance Viking Therapeutics’ pipeline. This role partners closely with internal discovery and development teams and with external CRO/CDMO organizations to drive programs from early development through late-stage clinical development and, as needed, toward commercialization readiness. The Associate Director will translate physicochemical properties and target product profiles into phase-appropriate formulation strategies, evaluating options and designing robust formulations across development stages. This position has responsibility for formulation strategy, process development, and manufacturing support, with an emphasis on oral solid dosage forms and injectable drug products (including subcutaneous presentations). The role will contribute to programs spanning Viking’s portfolio, including small molecule therapies and peptide-based therapies, and will apply life-cycle management principles to enable scalable, reliable, and patient-appropriate dosage forms. Essential Duties and Responsibilities The main responsibilities of this role include: • Lead governance of external CRO/CDMO partners for formulation and drug product development based on modality fit, technical capability, quality systems, and delivery performance., • Develop RFPs/SOWs and evaluate technical proposals to ensure alignment with target product profile (TPP), CQA/CPP strategy, timelines, and budget., • Define and execute formulation development and process optimization activities (e.g., preformulation, prototype development, DoE/QbD) to enable scale-up, GMP manufacture, packaging/labeling, and stability programs., • Own drug product development history and CMC documentation (development reports, control strategy, specifications, tech transfer packages) to support IND-enabling work, clinical supply, and lifecycle improvements., • Partner cross-functionally (CMC, Analytical, Nonclinical, Clinical Ops, QA, Regulatory, and Supply Chain) to align formulation strategy, risk mitigation, and stage-appropriate deliverables., • Author, review, and approve drug product CMC sections for IND/CTA submissions and amendments (e.g., 3.2.P), including comparability, change controls, and regulatory responses., • Maintain current knowledge of regulatory requirements, USP/ICH/FDA expectations, and cGMP requirements to ensure compliant, robust, and scalable drug product processes., • Communicate data-driven recommendations through protocols, reports, and presentations; present development strategy, risks, and tradeoffs to technical and executive stakeholders., • Drive execution in a fast-paced biotech environment, emphasizing scientific rigor, collaboration, and continuous improvement to advance programs to the clinic., • Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline, • At least 10 years of industry experience (title for this position will be commensurate with the candidate’s experience and qualifications) Knowledge and Skills • Highly familiar with current formulation principles and industry practices., • Extensive process development/ optimization, scale-up and process validation expertise, with emphasis on solid oral dosage forms., • Experience with injectable formulations and modern enabling technologies is a plus., • Track record of accomplishment in managing CMC drug product projects at early and late development stages., • Experience enabling external CRO/CDMO to achieve project goals on time and under budget. Approximate travel: less than 10% of the time VIKING THERAPEUTICS Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Salary Description $175,000.00 - $195,000.00 annual salary

Job Description Direct Counsel is seeking a Corporate Associate Attorney (Licensing) to join a leading Am Law 100 firm in its San Diego office. This is an outstanding opportunity for an associate attorney interested in sophisticated licensing, commercial contracting, and technology transactions within the life sciences, biotechnology, pharmaceutical, medical device, and software sectors. About the Role The Licensing & Technology Transactions team works closely with cutting-edge companies developing groundbreaking technologies and therapeutics. As a Corporate Associate Attorney, you will draft and negotiate complex commercial agreements, support strategic corporate transactions, and advise clients on intellectual property, regulatory considerations, and deal structures across all stages of the product and company lifecycle. This role offers substantial client contact, the ability to interact with scientists and business leaders, and meaningful responsibility on impactful transactions. What You’ll Do * Draft, review, and negotiate a broad range of commercial agreements, including: * Licensing, collaboration, development, and research agreements * Clinical trial, manufacturing, supply, and service agreements * Patent license agreements and IP assignments * Material transfer agreements, NDAs, and distribution agreements * Strategic alliance and commercialization arrangements * Advise clients on contract interpretation, risk assessment, and compliance issues * Conduct due diligence on IP assets and contractual obligations in corporate transactions * Review high-volume commercial documents such as confidentiality agreements and terms and conditions * Collaborate with scientists, executives, and cross-functional business teams to align legal strategies with operational and commercial goals * Stay current on regulatory and legal developments affecting life sciences and technology transactions What We’re Looking For * A highly skilled Associate Attorney with 3+ years of experience drafting and negotiating commercial contracts for life sciences or technology clients * Strong understanding of intellectual property issues, including patents, trademarks, trade secrets, and copyrights * Experience with software licensing, SaaS agreements, and technology transactions preferred * Familiarity with data privacy considerations and emerging issues involving AI * Excellent negotiation, communication, and problem-solving skills * Ability to manage competing priorities, meet deadlines, and maintain exceptional attention to detail * A collaborative mindset and professionalism when working with clients, colleagues, and cross-disciplinary teams Qualifications * JD or LLM from an ABA-accredited law school * Admission to practice in California (or eligibility to sit for/admit via reciprocity) * Background in biology, immunology, biochemistry, or a related scientific field strongly preferred * Experience supporting biotechnology, pharmaceutical, medical device, digital health, or related technology clients Compensation & Benefits The annualized salary range for this Associate Attorney position is $260,000 – $310,000, depending on experience and other permitted job-related factors. Attorneys are bonus-eligible and receive access to a comprehensive benefits package.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The In‑House Legal Counsel provides broad commercial and corporate legal support for Capricor’s growing operations, with a focus on contract negotiation, vendor management, commercialization readiness, and day‑to‑day legal advisory work across the business. Reporting to the General Counsel, EVP, this role partners closely with Commercial, Clinical, CMC, Quality, Regulatory, Operations, and Finance to ensure Capricor’s activities align with applicable legal, contractual, and industry standards. The ideal candidate is a motivated junior–mid level attorney with strong law‑firm training and experience supporting pharmaceutical or biotech clients, particularly in commercial contracting and product‑launch environments.Responsibilities • responsibilities include but are not limited to Commercial & Corporate Contracting, • Draft, review, and negotiate a wide variety of commercial agreements, including master service agreements (MSAs), CRO/vendor agreements, confidentiality agreements, supply and manufacturing agreements, consulting agreements, quality agreements, and technology-related contracts., • Provide day-to-day contract management, including issue spotting, risk assessments, and coordination with internal stakeholders., • Maintain and improve contract templates and contracting processes to support scalability and compliance., • Support contract lifecycle management systems and ensure timely routing, review, and execution. Commercialization & Pre-Launch Legal Support, • Provide legal guidance for commercialization planning including distribution, supply, marketing operations, and patient support programs., • Review commercial and vendor-related materials to ensure compliance with relevant industry standards and applicable laws. Vendor & Cross-Functional Support, • Provide legal support to ensure vendor obligations are contractually clear and aligned with operational needs. Corporate, Operational, & Compliance Support, • Provide legal support for internal reviews, investigations, and compliance initiatives in collaboration with the General Counsel and Compliance teams., • Support audit readiness and respond to legal document needs related to inspections or third-party assessments. General Legal Advisory, • Monitor relevant legal developments in pharma/biotech, including commercial, contracting, privacy, and healthcare law trends, and communicate implications to stakeholders., • Support special projects and new initiatives as Capricor scales toward commercial launch.Requirements, • J.D. from an accredited law school; active license to practice in California., • 5+ years of experience working in both a law firm and in‑house, supporting pharmaceutical and/or biotechnology companies., • Experience negotiating and reviewing contracts common to the life sciences sector (e.g., MSAs, CRO/vendor agreements, supply and manufacturing agreements, consulting agreements)., • Familiarity with commercialization activities in the pharmaceutical or biotech industry, including pre-launch and launch-stage considerations., • Ability to translate complex legal issues into practical, business-oriented guidance., • Strong communication, collaboration, and organizational skills. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description About Tr1X Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit . Position Summary The Senior Scientist, LNP Platform & Process Development (Scientist) is an experienced hands-on, lab-based, individual contributor that leads the design, development, and optimization of lipid nanoparticle (LNP) formulation and process development efforts supporting the Tr1X in vivo CAR-Treg platform. This individual plays a central role in developing and advancing the targeted lipid nanoparticle (tLNP) delivery systems from early research optimization through scalable, IND-enabling development. This is a high-impact, foundational role within the company. The Scientist helps design and implement the LNP backbone of the platform and influence both short-term program execution and long-term manufacturability strategy. The Scientist brings deep hands-on expertise in LNP formulation and process development, strong analytical rigor, and the ability to thrive in a fast-paced startup environment. Key Responsibilities • Contribute to the design, development, and optimization of LNP formulations for mRNA delivery, including targeted LNP systems incorporating conjugated or functionalized lipids., • Evaluate lipid composition, formulation parameters, and mixing conditions to optimize particle size, polydispersity, encapsulation efficiency, stability, release characteristics, and biological performance., • Develop scalable, GMP-compatible manufacturing processes to support program advancement., • Apply Quality by Design (QbD) principles and Design of Experiment (DoE) studies to study design and execution., • Lead the development and optimization of analytical characterization methods (both in-house and at the external CDMO), including but not limited to DLS, fluorescence-based assays such as Ribogreen, HPLC/UPLC methods (CAD, UV, IP-RP, SEC, IEX), LC-MS, and endotoxin testing., • Interpret analytical and stability data to establish meaningful correlations between physicochemical properties and biological function., • Collaborate closely with platform biology teams to support in vitro and in vivo studies, prepare development reports and technical documentation, and contribute to technology transfer activities with external CDMO partners., • Spearhead IND-enabling documentation and contribute to defining the long-term strategy for scalable LNP platform development., • Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a related field with a minimum 4 years of relevant industry experience; or M.S. with 8+ years; or B.S. with 10+ years., • Demonstrated in-depth expertise in LNP formulation and process development, including hands-on experience with microfluidic or scalable mixing technologies and downstream purification strategies such as TFF., • Strong experience with analytical characterization of LNP systems and application of statistical design tools for process optimization., • Highly organized, scientifically rigorous, and capable of independently driving projects while collaborating effectively in a multidisciplinary startup environment., • Experience with mRNA therapeutics or nucleic acid delivery systems., • Prior exposure to immunotherapy or cell therapy platforms preferred., • Familiarity with regulatory expectations for CMC development and experience supporting technology transfer to external manufacturing partners preferred., • Excellent written and oral communication skills., • Strong analytical and problem-solving skills; great attention to detail and the ability to drive timely and fact-based decision making., • Ability to function in a rapidly changing environment and handle multiple priorities., • Demonstrated ability to partner, build trust, and cultivate positive working relationships with CDMOs., • Experience with mRNA production and analytical quality control preferred., • Effectively communicate changes and resolve issues with CDMOs., • Lead and/or participate in cross functional development and manufacturing projects to ensure company objectives are met and exceeded., • Legally authorized to work for any employer in the U.S., • Position is on site in San Diego Working at Tr1X At Tr1X, our team is united by a singular shared mission: to transform patients' lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured. Base Pay Range Anticipated: $145,000 - $160,000 Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position. Compensation and Benefits Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays. Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at . Notice to Employment Agencies The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.