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Manufacturing Associate / Technician Location: Onsite – San Diego, CA Relocation assistance is not provided for this role. Candidates must be able to work from the listed location without relocation support. Type: Full-Time - Direct Hire Shift: Training on first shift with a transition to supporting 2nd shift operations Industry: Pharmaceutical / Biotech (GMP) Role Overview NCC Talent Solutions is partnering with a Contract Manufacturing Organization in San Diego to scale up their manufacturing team to support a growing GMP operation. We are seeking multiple Manufacturing Technicians and Associates (level based on experience) to support sterile drug product manufacturing within a GMP-regulated cleanroom environment. This role is responsible for executing aseptic fill & finish operations, supporting cleanroom maintenance, and ensuring all production activities meet the highest standards of quality and compliance. This is an excellent opportunity for a technician who has prior experience in an aseptic processing facility. How you will make an impact: • Execute batch production records and follow all SOPs for sterile manufacturing operations, • Perform aseptic fill & finish activities in a GMP cleanroom environment, • Operate and maintain filling and production equipment, • Perform filter integrity testing and in-process checks, • Conduct visual inspection of filled vials for quality and compliance, • Perform environmental monitoring (viable and non-viable), • Support stocking and inventory of cleanroom and production supplies, • Assist with cleanroom and equipment validation activities, • Accurately complete all GMP documentation and batch records, • Participate in media fills and aseptic process qualifications, • Assist in drafting and updating SOPs and Master Batch Records, • Provide input for CAPA investigations related to deviations, sterility failures, and non-conforming materials The experience you will bring: • Bachelor’s degree in Life Science. Experience will be considered in luie of education., • Typically requires 3–7+ years of experience in GMP-regulated pharmaceutical or biotech environments with experience executing activities in an aseptic manufacturing environments. Experience in drug product/drug substance manufacturing preferred., • Hands-on experience with aseptic processing and cleanroom gowning, • Strong ability to read, interpret, and execute batch records and SOPs, • Ability to interpret technical instructions, including diagrams and procedures, • Ability to lift up to 50 pounds, • Requires normal near visual acuity and the ability to distinguish colors, with or without corrective lenses., • Ability to wear cleanroom PPE and gowning (including goggles, face shields, respirators, gloves) for extended periods (up to 4 hours at a time), • Comfortable working in a controlled cleanroom environment for the majority of the workday

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Instrument Verification and Validation Engineer to support our Instrument Systems team. This role provides Instrument Verification and Validation (V & V) support for new products, assay / instrumentation integration, technology transfer and other instrument V & V activities. Integrates engineering theory and practice within the areas of new product development, manufacturing, and marketing support. This position will be onsite full-time working out of San Diego, CA - Summers Ridge, HQ. Note: This position is not currently eligible for visa sponsorship. The Responsibilities • Participates on design teams, understands project goals and timelines, and provides support to ensure product launch success., • Communicates project status, challenges, and concerns to area management pro-actively., • Writes instrument design control documentation and executes associated test and risk management activities., • Works with R&D on instrument V & V approaches to develop, automate, optimize, and integrate diagnostic assays with instrumentation., • Maintains project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process., • Supports the Instrument Systems product vision on project teams., • Provides instrument software provision in the development and implementation of functional strategies to support corporate goals and objectives., • Carries out duties in compliance with established business policies., • Test Automation setup and development., • Perform other work-related duties as assigned. The Individual Required: • Bachelor's or master's degree in computer science, Mechanical Engineering, Electrical Engineering, System Engineering or any other related fields required., • From 1 to 5 years of experience required, preferably in a pharmaceutical or medical device environment., • An understanding of IEC 62304 (Medical Device Software - Lifecycle process) or equivalent FDA software development requirements., • Good analytical and problem-solving skills., • Good organizational skills, and the ability to manage multiple tasks., • Experience in product development and experimental design., • Ability to work within cross functional teams., • Strong communication skills, written and verbal., • Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation., • Working knowledge of relevant analytical tools., • Ability to participate in planning and managing projects., • Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management)., • Knowledge of related quality systems regulations and processes., • Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)., • Must have some knowledge of basic Programing, Scripting, setting up an Automation Environment and Test Automation development., • Knowledge of Application life cycle management (Agile method preferred)., • Know and understand the software test cycle., • Ability to write test plans, test cases and test reports., • Ability to travel up to 5% Preferred: • Instrument V&V Theory & Application., • ISO 13485, ISO / EN ISO 14971 and FDA QSR experience. The Key Working Relationships Project Managers and R&D Directors to address problems, identify solutions, resolve timelines issues, and communicate conflicting project goals. Contract product development teams to ensure products meet Quidel requirements and quality standards and are documented in accordance with ISO and FDA requirements. Provides updates to Management and to Project Teams, when participating in cross-functional teams. Ensures all issues related to the success of the product launch are communicated to the Manager Quality Assurance. The Work Environment The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples. Position requires ability to lift to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted. Occasional travel required. Travel includes airplane, automobile travel and overnight hotel. Physical Demands No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $85,000 to $95,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-TO1

Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID:26-08555 Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: • Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable)., • Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions., • Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules., • Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts., • Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle., • Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively., • Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed., • Foster a collaborative, innovative, and compliant culture within program teams., • Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management., • Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action., • Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals, • Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required., • Ensure compliance with quality management systems and regulatory requirements, where applicable., • Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data., • Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines, • Drive design control discipline throughout product development, ensuring compliance, • Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance., • Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification., • Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing., • Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification., • Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.)., • Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs., • Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target Key Requirements and Technology Experience: • Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent., • 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment., • Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval)., • Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR)., • Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software., • Project Management Professional (PMP) certification not required but is preferred, • Scrum Master and SAFE Agile certification is preferred., • Experience in medical device industries required, including experience in FDA or other regulated environments., • Knowledge of the medical device industries beneficial integrating science and technology into business processes., • Technical background in electrical, mechanical, or biomedical engineering, • Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones., • Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines, • Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures., • Drive for accountability within self and others., • Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations, • Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements., • Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality., • Direct experience with major test labs and certification bodies for medical electrical equipment standards., • Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus), • Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification., • Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements., • Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations. Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy ___.

Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR Consulting has offices in Canada, USA, and Australia. This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. This role is for CQV Engineer role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The work will require working out of the client’s facilities in San Diego, California. Responsibilities • Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, centrifuges, etc., • Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant., • Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met., • Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports., • Experience with C&Q of process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset., • Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates., • Engage other departments, as required, for design reviews and decisions., • Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs)., • Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases., • Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc., • Visit construction and installation sites following all site safety requirements., • 3-6+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry., • Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline., • Excellent written and spoken English is required including the preparation of technical documents in English, • Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation., • Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required., • Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required, • Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset., • Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset., • Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports., • Ability to lift 50 lbs., • Ability to handle multiple projects and work in a fast-paced environment., • Strong multi-tasking skills Salary range: 80,000$ -120,000$ based on experience. Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Job Description Role Overview PrideStaff is seeking an experienced Manufacturing Technician to support sterile fill and finish operations in a GMP-regulated clean room environment. This role is responsible for executing batch records, performing aseptic processing, and supporting quality-driven pharmaceutical manufacturing operations. Key Responsibilities • Execute batch production records in compliance with GMP standards, • Perform sterile fill and finish operations, • Operate filling and processing equipment, • Conduct visual inspections and filter integrity testing, • Perform environmental monitoring (viable and non-viable), • Support clean room maintenance and validation activities, • Collaborate with Operations and Quality Assurance teams Qualifications • 3–5 years of experience in a GMP clean room or aseptic processing environment preferred, • Bachelors Degree in life sciences preferred; equivalent experience considered, • Experience with sterile gowning and clean room procedures, • Ability to accurately execute batch records and follow SOPs, • Strong attention to detail and documentation skills, • Ability to lift up to 50 pounds, • Ability to wear protective clean room equipment for extended periods Company DescriptionPrideStaff is a national staffing organization, delivering innovative solutions to the challenges employers face every day. Over the years, PrideStaff has been a consistent industry leader, developing technology and service processes that allow our organization to deliver superior performance. With locations across the United States, we're well positioned to partner with clients and candidates to ensure a successful match of employee talent with customer needs. When it comes to your success, we leave nothing to chance! Our Mission: Consistently provide client experiences focused on what they value most.PrideStaff is a national staffing organization, delivering innovative solutions to the challenges employers face every day. Over the years, PrideStaff has been a consistent industry leader, developing technology and service processes that allow our organization to deliver superior performance. With locations across the United States, we're well positioned to partner with clients and candidates to ensure a successful match of employee talent with customer needs. When it comes to your success, we leave nothing to chance! \r\n\r\nOur Mission: Consistently provide client experiences focused on what they value most.

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 ___.

Number ICIMS-2026-9916 Job function Admin/Office Support Job type Temporary Location Werfen - San Diego - WBH - 6260 Sequence Drive San Diego, California 92121 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 Quality Records Coordinator is responsible for the review and audit of Manufacturing and Quality Control (QC) related records associated with the release of products in manufacturing, primarily product Device History Records (DHRs). The Quality Records Coordinator oversees the review of DHRs in order to complete the final release of accepted sub-components and finished good products. Responsibilities Key Accountabilities: • Review DHRs for assigned products; as appropriate, approve product release through the Enterprise Resource Planning system (ERP)., • Audit DHRs to ensure accuracy, legibility, and traceability, • Continually work to achieve assigned review time goals; meet unscheduled in workload as necessary to ensure timely release of product., • Responsible to scan/archive completed DHRs, • Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve ques- tions, inconsistencies, or missing data issues., • Remain current with all specifications and requirements on which quality records are based., • Remain up to date with current Good Manufacturing Processes (cGMP), as well as with manufacturing's mate- rial/product process flow., • Provide data and metrics related to accuracy, completeness and cycle times for records being reviewed., • Ensure priority to urgent matters., • Provide additional administrative support as directed., • Participate in regulatory audits as needed., • Ensure and maintain compliance with the company's quality system requirements through training and adher- ence to policies, procedures, and processes., • Other duties as assigned., • Carries out duties in compliance with established business policies., • Interface with all functions and levels of management as needed., • DHR Review and Release, • Deviation process (Affected DHRs), • Nonconformance process, • Quality Control, • Planning, • Engineering Minimum Knowledge & Experience Required for the Position: • High school diploma; Bachelor's degree (Life Sciences) a plus., • Knowledge of cGMP, GDP, FDA, and ISO preferred., • Working knowledge of Microsoft Office., • Experience with large enterprise resource planning (ERP) system and accounting software packages preferred., • Previous regulatory audit experience a plus., • Technical writing background/experience a plus, • Must be self-motivated and could work with minimal supervision; must also be able to work as part of a team., • Good communication, organizational, and time management skills; ability to pay close attention to detail., • Ability to work as part of a team., • None 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.

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. We are seeking a driven and detail-oriented Facilities Associate II / III to support and lead GMP facility operations. This individual will be responsible for independently managing equipment calibration and maintenance programs, coordinating complex vendor activities, and contributing to continuous improvement initiatives across facilities and compliance systems. The ideal candidate brings hands-on GMP experience, demonstrates sound judgment in a regulated environment, and takes initiative in solving operational issues. This role is based at our headquarters in San Diego, CA.RESPONSIBILITIES • Own and manage the calibration and preventive maintenance program for GMP-critical equipment, ensuring accuracy, compliance, and timely execution., • Lead the induction of new controlled assets into the inventory and maintenance tracking systems., • Independently execute and improve daily, weekly, and monthly facilities operations to support manufacturing and laboratory readiness., • Develop, revise, and optimize calibration and preventive maintenance schedules in alignment with operational needs and regulatory standards., • Create and maintain accurate equipment documentation, including maintenance logs, procedures, and records., • Schedule and coordinate maintenance and calibration work with external vendors and internal teams, ensuring minimal disruption to production and lab activities., • Drive vendor qualification processes in partnership with Quality Assurance, including documentation review and audit support., • Collaborate with Quality Engineering to ensure timely completion and closure of equipment work orders, deviations, and change controls., • Act as a key contact for troubleshooting and resolving equipment issues, coordinating repairs and root cause analysis with vendors., • Initiate and support quality records, including deviations, CAPAs, and change controls that impact GMP operations and facilities infrastructure., • Identify and recommend process improvements to enhance facility efficiency, compliance, and reliability.REQUIREMENTS, • Bachelor’s degree in Engineering, Life Sciences, or related field preferred; equivalent hands-on experience in GMP environments will be considered., • 3–5+ years of experience in a GMP-regulated facilities or equipment maintenance role, ideally in biotech or pharmaceutical manufacturing., • Strong understanding of GMP compliance, calibration standards, and equipment lifecycle management., • Demonstrated ability to manage vendors, prioritize competing tasks, and work independently with minimal supervision., • Proficiency in equipment tracking and maintenance systems; experience with CMMS or QMS software a plus., • Excellent written and verbal communication skills for clear documentation and cross-functional collaboration., • Exceptional organizational skills and attention to detail, with a proactive and solutions-oriented mindset.Work Environment / Physical Demands:, • Must be able to sit and stand for extended periods. 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.

Be visionary Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins. Job Description JOB SUMMARY The Senior Buyer is responsible for sourcing and procuring goods and services-such as raw materials, tools, and electronic components-to support manufacturing operations. This role involves planning purchases, resolving part shortages, negotiating vendor contracts, and driving cost and vendor reductions. The position supports engineering during product development and manages procurement through ERP systems, particularly Microsoft AX. Candidates should have experience in a manufacturing environment, strong communication skills, and familiarity with kanban systems and commodity agreements. RESPONSIBLILITIES \n • Manage Suppliers in all aspects of Supply Chain including quality, on time delivery, scheduling, inventory management, and contract negotiation.\n, • Measure and manage the vendor and supplier cost, quality, and delivery performance.\n, • Work closely with the production team to align procurement activities with production schedules and ensure the timely availability of necessary raw materials.\n, • Proactively resolve production part shortages to maintain uninterrupted manufacturing operations.\n, • Identify, evaluate, and select suppliers who can provide the necessary commodities at the best quality, price, and delivery terms.\n, • Negotiate with suppliers and find ways to reduce costs without jeopardizing the quality and delivery of the components.\n, • Identify and implement cost reduction opportunities through negotiation, sourcing strategies, and efficiency improvements.\n, • Responsible for various reporting and follow up including Open Purchase Orders, Late Purchase Orders, Delivery Schedules, Inventory Coverage, and Supplier On Time Performance.\n, • Propose continuous improvement changes and processes when required.\n, • Work individually, and as part of a team in a fast-paced environment.\n, • Perform duties in accordance with policies and procedures.\n, • Other duties as assigned.\n\n QUALIFICATION & SKILL: \n • Bachelor's degree prefers with a minimum of 7-10 years of sourcing experience.\n, • Proficient in ERP/MRP systems; experience with Microsoft AX is a strong plus.\n, • Skilled at multitasking and meeting tight deadlines under pressure.\n, • Ability to read and understand BOMs and drawings.\n, • Ability to interact with a diverse team at all organization levels.\n, • Experience with Electronic components and/or PCBA's preferred.\n, • Experienced in managing kanban purchase orders and long-term purchase agreements.\n, • Assist with the continuous improvement of procurement and compliance related policies, forms, and training materials.\n, • Excellent verbal and written communication skills.\n, • Strong team player with demonstrated initiative and leadership potential.\n, • Mentor and provide guidance and support to junior members of the purchasing team.\n, • Strong knowledge of Microsoft Excel, Word, PowerPoint, Teams required.\n\n PHYSICAL & TRAVEL REQUIREMENTS \n • The physical requirements of the position require the ability to sit at a computer workstation for an extended period of time with repetitive utilization of a computer, keyboard, mouse, and desk phone.\n, • The position will require the ability to stand, walk, reach, push, pull, bend, and lift no more than 20 lbs.\n, • The position will require up to 20% travel, potentially including international travel, for supplier visits and other business-related support activities.\n\n Salary Range: $62,800.00-$83,700.000 Pay Transparency The anticipated salary range listed for this role is only an estimate. Actual compensation for successful candidates is carefully determined based on several factors including, but not limited to, location, education/training, work experience, key skills, and type of position. Teledyne conducts background checks on qualified applicants who receive a conditional offer of employment in accordance with applicable laws, regulations and ordinances. Background checks may include, but are not limited to, education verification, employment history and verification, criminal convictions, Motor Vehicle Report (MVR & driving history), reference check, credit checks/credit history and drug testing. All qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions. Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 Join our People Services & Culture team as a Talent Acquisition Partner at Arrowhead Pharmaceuticals in San Diego, CA, and play a vital role in building our high-performing team. In this dynamic role, you will lead full-cycle recruitment, including sourcing, screening, scheduling, interviewing, and offer management, ensuring a seamless and engaging candidate experience. You will collaborate with hiring managers across multiple locations—Pasadena, CA, San Diego, CA, Madison, WI and Verona, WI—to attract top talent and drive hiring strategies. As a strategic and detail-oriented recruiter, you'll leverage your relationship-building to connect great people with great opportunities. Reporting to the Manager, Talent Acquisition, this role offers the chance to make a meaningful impact on Arrowhead's growth, culture, and success. This position is fully onsite, 5 days a week based from our Corporate Headquarters in San Diego, CA. This position is a 6 month contract. Responsibilities • Full-Cycle Recruitment: Manage the end-to-end hiring process, from building job descriptions, sourcing and screening candidates to interviewing, and extending offers, • Candidate Experience: Ensure a smooth, engaging, and professional candidate journey throughout the recruitment process., • Scheduling & Coordination: Partner with hiring managers to coordinate interviews, manage calendars, and facilitate efficient scheduling., • Stakeholder Collaboration: Work closely with hiring managers, People Services & Culture, and business leaders to understand talent needs and help implement recruitment strategies., • Talent Sourcing: Leverage job boards, networking, referrals, and direct outreach to identify and attract top talent., • Applicant Tracking: Maintain accurate and up-to-date records in the Applicant Tracking System (ATS) to ensure compliance and reporting accuracy., • Employer Branding: Represent the company at career events, networking functions, and industry forums to enhance employer brand presence., • Market Insights: Stay informed on hiring trends, compensation benchmarks, and recruitment best practices to advise hiring managers effectively., • Recruitment Operations: updating and organizing key resources such as the organizational chart and other hiring-related documentation., • Bachelor's degree in Science, Human Resources, Business Administration, or a related field., • 3+ years of full-cycle, high volume recruitment experience in a corporate or agency setting, • Strong experience in scheduling, interviewing, extending offers, and salary negotiations., • Ability to build strong relationships with hiring managers, candidates, and People Services & Culture site partners., • Excellent communication, organization, and time management skills., • Proficiency in Applicant Tracking Systems (ATS) and recruitment tools., • Enjoys working on a computer and in an office setting, • Self-starter who is motivated to complete and prioritize tasks, • Recruiting experience for pharmaceutical, biotech or other R&D organizations All applicants must have authorization to work in the US for a company. 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: The Region Head is an experienced and strategic senior leader responsible for the West Region (San Diego and San Francisco areas) within Syner-G's Technical Operations business. This leader will direct a team of engineering consultants who deliver high‑quality technical operations support to clients in the life sciences sector, including biotech, pharmaceutical, and medical device organizations. The support provided to our clients is typically inclusive of complex, highly technical, and demanding projects. The Region Head holds full accountability for regional P&L performance, financial planning, client growth, and operational execution, while ensuring a high level of employee engagement and client satisfaction. This role will partner closely with the Commercial team to expand existing accounts, identify new opportunities, and grow the company's footprint within the region. Establishing and developing teams with a strong client focus and culture of delivery excellence is essential to the success of the West Region. WORK LOCATION: This role is expected to reside within the West Region. Travel to existing client sites, future client sites, and the Syner-G San Diego office will be required based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) Regional Leadership & Operations • Provide strategic and operational leadership for all activities within the West Region., • Oversee regional business performance, including P&L management, budgeting, forecasting, and financial reporting., • Ensure consistent delivery excellence across all client engagements, aligned to company standards and industry best practices., • Lead, coach, and inspire a team of engineering professionals across multiple projects.., • Build an engaged and motivated workforce through effective talent development, performance management, and career pathing., • Serve as the senior point of escalation and strategic advisor for key clients in the region., • Partner with the Commercial team to expand existing accounts and identify new business opportunities., • Engage in business development activities including client meetings, capability presentations, and proposal development., • Build strong relationships with industry stakeholders, understanding evolving client needs and market trends., • Develop and maintains relationships with local A/E (architectural/engineering), MEP, and construction firms to build a trusted network of partners for facility design, build, and expansion projects., • Ensure all consulting services adhere to relevant life sciences regulations, industry standards, and best practices., • Promote continuous improvement in methodologies, tools, and technical frameworks., • Build productive relationships with Commercial, Marketing, and other internal Syner-G functions (HR, Finance, Talent Acquisition) to support delivery of services to the customer and minimize risk to the business., • Update leadership team on strategic account plans and accomplishments, opportunities/risks and financial results while forecasting anticipated impacts to plan., • Partner with other service delivery groups to identify and pursue cross-sell opportunities outside of Technical Operations., • Develop annual operating budgets and periodic forecasts, manages regional P&L to meet regional and company goals., • Consistent year‑over‑year revenue and margin growth in the West Region., • High levels of team engagement, retention, and professional development., • Expansion of existing client relationships and successful acquisition of new clients., • Delivery of high-quality consulting services., • Strong collaboration with Commercial, HR, Operations, and Leadership teams. QUALIFICATIONS AND REQUIREMENTS Education: • 15 or more years of experience in project delivery, engineering, operations or technical program management., • 8 or more years of leadership in GMP manufacturing facility design, construction, startup, engineering, and/or operations., • Demonstrated business development success, with the ability to sell services and expand client relationships in a competitive environment, • Deep experience in one or more of the following areas: Capital Projects, Facilities Engineering, Process, Automation, CQV, and/or Project Management, • Ability to build, develop, and motivate high-performing teams to support and deliver multiple projects under demanding timelines, • Proven track record of project delivery for laboratory and/or manufacturing facilities and operations in regulated industries such as biotech, pharmaceuticals, or advanced therapeutics., • Exceptional senior customer relationship and client management skills, • Visionary thinker with ability to create strategies for growth within established and new accounts, • Excellent communication, leadership, and organizational 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 or hybrid work options for some roles. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Additionally, our Technical Operations team regularly work at physical client sites. 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 Title: Sr. Packaging Specialist Location: San Diego, CA 92121 Duration: 03 Months Onsite Position - Shift - Mon-Fri 8AM - 4:30PM Description: The Sr. Packaging Specialist must be able to work in a team environment to offer quality packaging and labeling of customer’s clinical trials. This position is expected to lead production rooms and ensure quality product is outputted from production batch records. Additionally, this role will have responsibilities for label control and training of new staff. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time. Essential Functions: • Lead production rooms and runs from pre-line, execution, to post-line activities, • Perform production EBR review, • Responsibilities for label control including label printing, creation of master blinding forms, and initial/final inspection of labels, • Fastchain Productions and Management of 3-day Turnaround Time, • JDE SME for production activities, • Responsible and perform OJT for production team members, • Shared responsibilities with the Production Manager on maintaining the production schedule and management of staff in rooms on a day-to-day basis, • May be responsible for assisting investigations related to any deviations or customer complaints from the result of operational processes, • Inspect blister cavities for missing products, burnt product, holes in foil, print registration, missing print, crushed blisters and seal integrity., • Fill tablet, bottle, desiccant and closure hoppers. Hand count product using counting trays., • Manufacturing responsibilities include de-inking product, tablet breaking, product placement into oversized capsules and capsule inspection., • Inspect bottles for misalign closures, print registration and missing print copy., • Inspect seal integrity of pouch, print registration and missing print copy., • Inspect blister units and place them into properly assigned card locations for multi-fill operations., • Responsible for cleaning machine equipment and production rooms as stated in cleaning SOP’s., • Fill in all appropriate information in the cleaning logbooks., • Responsible for cleaning product contact parts., • When working on look-alike products you are only allowed to work with your assigned product. Multi-fill projects require that employees do not touch or help other employees that are assigned different products., • Responsible for cleaning production rooms with three bucket sponge mop cleaning system which includes ceilings, walls and floors., • All clinical labels must be inspected and require 100% accountability. Clinical labels can be either manually or automatically applied., • Sealed clinical cards must be inspected for missing copy, poor seal, smudges and dirt, misalign blister units and burnt product., • Inspection required for vials, ampoules and syringes utilizing black and white light boxes., • Cold storage packaging will also be required working with cold products, both outside and inside refrigeration conditions., • Assembly work required, which may include utilizing barcode scanning equipment and computers., • Other duties as assigned. Position Requirements: Education or Experience: • Bachelor’s degree preferred., • Minimum of 6 years of relevant industry experience in a cGMP environment, or comparable pharmaceutical or clinical knowledge and experience., • Minimum of 4 years of operating and maintaining packaging equipment (blistering, bottling, carding) or relevant packaging equipment experience.

GMP quality assurance in the pharmaceutical industry with at least 2 years in a managerial/leadership capacity. Manager/ Associate Director of GMP Quality Assurance will be responsible for quality oversight for GMP activities to support third party manufacturing, packaging, testing, and supply of dr

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 Description ADDRESS - 8926 WARE COURT, SAN DIEGO, CA 92121 SHIFT - MON-FRI 8AM - 4:30PM The Sr. Packaging Specialist must be able to work in a team environment to offer quality packaging and labeling of customer’s clinical trials. This position is expected to lead production rooms and ensure quality product is outputted from production batch records. Additionally, this role will have responsibilities for label control and training of new staff. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time. Essential Functions: • Lead production rooms and runs from pre-line, execution, to post-line activities, • Perform production EBR review, • Responsibilities for label control including label printing, creation of master blinding forms, and initial/final inspection of labels, • Fastchain Productions and Management of 3-day Turnaround Time, • JDE SME for production activities, • Responsible and perform OJT for production team members, • Shared responsibilities with the Production Manager on maintaining the production schedule and management of staff in rooms on a day-to-day basis, • May be responsible for assisting investigations related to any deviations or customer complaints from the result of operational processes, • Inspect blister cavities for missing products, burnt product, holes in foil, print registration, missing print, crushed blisters and seal integrity., • Fill tablet, bottle, desiccant and closure hoppers. Hand count product using counting trays., • Manufacturing responsibilities include de-inking product, tablet breaking, product placement into oversized capsules and capsule inspection., • Inspect bottles for misalign closures, print registration and missing print copy., • Inspect seal integrity of pouch, print registration and missing print copy., • Inspect blister units and place them into properly assigned card locations for multi-fill operations., • Responsible for cleaning machine equipment and production rooms as stated in cleaning, • Fill in all appropriate information in the cleaning logbooks., • Responsible for cleaning product contact parts., • When working on look-alike products you are only allowed to work with your assigned product. Multi-fill projects require that employees do not touch or help other employees that are assigned different products., • Responsible for cleaning production rooms with three bucket sponge mop cleaning system which includes ceilings, walls and floors., • All clinical labels must be inspected and require 100% accountability. Clinical labels can be either manually or automatically applied., • Sealed clinical cards must be inspected for missing copy, poor seal, smudges and dirt, misalign blister units and burnt product., • Inspection required for vials, ampoules and syringes utilizing black and white light boxes., • Cold storage packaging will also be required working with cold products, both outside and inside refrigeration conditions., • Assembly work required, which may include utilizing barcode scanning equipment and computers., • Minimum of 6 years of relevant industry experience in a cGMP environment, or comparable pharmaceutical or clinical knowledge and experience., • Minimum of 4 years of operating and maintaining packaging equipment (blistering, bottling, carding) or relevant packaging equipment experience. Company DescriptionAbout company - Since its founded in 1996, CTC has grown into a trusted global partner in AI & ML, Enterprise Applications, Digital Services, Managed Services, and Business Services. With headquarters in Detroit, Michigan, CTC has a team of over 2,000 experts worldwide. We empower more than 100 organizations to tackle complex challenges and transform them into sustainable competitive strengths--driving innovation, efficiency, and growth every step of the way. Our strengths have always been Commitment to Customer, Commitment to Colleagues, and Commitment to Community (CTC).About company - Since its founded in 1996, CTC has grown into a trusted global partner in AI & ML, Enterprise Applications, Digital Services, Managed Services, and Business Services. With headquarters in Detroit, Michigan, CTC has a team of over 2,000 experts worldwide. We empower more than 100 organizations to tackle complex challenges and transform them into sustainable competitive strengths--driving innovation, efficiency, and growth every step of the way. Our strengths have always been Commitment to Customer, Commitment to Colleagues, and Commitment to Community (CTC).

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 DescriptionCompany Description CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. Job Description The Mechanical Engineer IV focuses on the design and engineering of HVAC and mechanical utilities for buildings. The individual possesses demonstrated ability to manage multiple complex tasks, establish priorities and direct the work of others. This position is responsible for overseeing the Mechanical discipline scope of work and managing the discipline budget on all project phases, sizes and levels of complexity, and coordinating with internal and external architects and engineers, as well as clients, construction managers, subcontractors, vendors and manufacturers. Typical tasks and deliverables that are executed by or under the supervision of the Mechanical Engineer IV include site selection, master planning, commissioning and startup, load calculations, utility assessments, energy modeling, design reports, code evaluations, plans, P&IDs, schedules, HAZOP reviews, installation details, equipment and system selection and specification, and coordination with manufacturers and trade partners. Project work includes directing design activities for all levels of design such as studies, conceptual and schematic design, design development, construction documentation and construction administration. The Mechanical Engineer IV understands the development and field implementation of documents through all project phases, sizes and levels of complexity. Within this role there are multiple positions, and their focuses are described below. Core Activities • Interfaces with client and external partners., • Works closely with other architects, engineers and designers, as well as other internal and external team members to ensure a coordinated, constructible and complete design., • Works with a Project Manager on proposal development, designs task identification, man-hour planning and project scheduling for the mechanical scope of work on projects., • Conducts and leads field surveys of existing conditions and support of field reporting., • Identifies and resolves intermediate non-compliant existing conditions during site walks and construction field surveys., • Develops narratives, reports and construction drawing packages and writes construction specifications on large projects of advanced complexity with no oversight., • Provides lead and advanced support of construction activities such as RFI responses, submittal reviews, punch list development and construction progress reports., • Conducts quality checking of documents for intermediate complex projects (e.g., technical verification of design calculations and documentation) and drives overall project quality., • Utilizes various platforms to execute work, such as Microsoft Office products and available BIM software., • Provides mentorship to less experienced Mechanical Engineers and/or Designers., • Leads advanced project system design programming and master planning with support from Senior Engineer., • Leads a team of mechanical staff in the execution of advanced projects discipline design and engineeringQualifications, • ABET-accredited Bachelor’s degree in Mechanical Engineering or Architectural Engineering (with a mechanical focus), • Minimum of 10 years of experience, • Professional Engineer registration in good standing, • Advanced experience with performing engineering calculations, and developing and implementing HVAC, mechanical utility and piping systems designs, • Life Sciences (Pharmaceutical, Biotech, Laboratory) or Food & Beverage industry experience, • Advanced knowledge of GMP manufacturing environments, • Proficiency in Revit and AutoCAD, • Proficiency in Microsoft Office suite, • LEED, WELL or other sustainable design accredited professional or, experience with sustainable design, • Intermediate experience with using and applying other applicable industry standards (ASHRAE, SMACNA, ISPE, FDA, ISO, NFPA, OSHA, etc.), • Advanced experience conducting and leading field surveys of existing conditions and support of field reporting, • Advanced experience in plumbing design, • Basic experience using Revit plugins such as Enscape and Unifi, • Basic experience building parametric workflows using Dynamo, Grasshopper, and/or Rhino within Revit, • Proficient with advanced internal and external cross-discipline project team coordination, • Proficient with advanced coordination with construction trade partners, vendors and manufacturers, • Intermediate experience with troubleshooting issues with mechanical systems, • Ability to develop intermediate internal mechanical design and engineering training presentations, • Ability to travel for client development and project execution, and internal and external training opportunities Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 All applicants must have authorization to work in the US for a company. 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 Validation Engineer with 4–7 years of experience to support the development, execution, and management of validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes. This role is responsible for ensuring compliance with internal quality standards and regulatory requirements by generating, executing, and maintaining validation lifecycle documentation. The Validation Engineer will play a key role in supporting operational readiness, tech transfer, and continuous improvement initiatives. KEY RESPONSIBILITIES (This list is not exhaustive and may be supplemented or adjusted as needed.) • Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets., • Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports., • Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures., • Prepare summary reports for validation, verification, commissioning, and requalification activities., • Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions., • Perform P&ID walkdowns to verify installation and system readiness., • Conduct thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes., • Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation. Education • 4–7 years of experience in the biotech, pharmaceutical, or medical device industry., • Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles., • Hands‑on validation experience in equipment, computerized systems (CSV), analytical methods, and process validation., • Experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation., • Strong verbal and written communication skills, with the ability to explain technical concepts to non‑technical stakeholders., • Detail‑oriented with strong organizational and documentation skills., • Ability to work independently and collaboratively in a fast‑paced, regulated environment. 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. COMPENSATION: The expected salary range for this position is $110,000 to $130,000 yearly. 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 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 MSAT Associate 2 supports cGMP manufacturing operations through technical writing, investigation management, and process-focused scientific problem solving. This role requires a strong understanding of cell therapy or biologics manufacturing and a demonstrated ability to analyze data, manage quality events, and provide real-time support to production activities. In this position you will act as a Subject Matter Expert (SME) across manufacturing processes, supporting technology transfer, continuous improvement, deviation investigations, and the development and revision of controlled documentation. This position partners closely with Manufacturing, QA, Process Development, and Supplier Quality to ensure compliant, efficient, and well‑documented operations. Responsibilities • Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments., • Management of deviations and other quality records, performing root cause investigations (6M, 5-Why’s, etc) to determine causal factors and evaluate product impact., • Training on the cell therapy and/or exosome platforms quickly to assist in product impact assessments, and compiling scientific data relating to the manufacturing processes., • Assisting with tech transfers into cGMP Manufacturing, ensuring the transfer is controlled and executed within GMP regulatory guidelines., • Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use., • Assisting on revising (as needed) and reviewing process-related manufacturing documentation (batch records, SOPs, bills of material, process flow diagrams) to assure all clinical products meet the requirements for quality, safety and efficacy., • Providing in-person and real-time manufacturing production support as needed., • Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances., • Identifying continuous improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance in cross functional collaborations., • Working closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations., • Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, and an error prevention/continuous improvement mindset., • Performing such other duties as may be assigned to you from time to time.Requirements, • Bachelor’s degree and 2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience., • A minimum of 1 year experience in adherent cell culture. Additional experience with cells in suspension is a plus., • Experience with writing/revising technical documents is required (SOPs, Forms, Batch Records, etc)., • Previous experience with, or knowledge/understanding of, various quality events is required (Deviations, CAPAs, Change Controls etc)., • Deep understanding of cell culture and ability to troubleshoot common processing issues., • Experience with scale-up of cell therapy processes and closed manufacturing systems preferred., • Ability to collect and assist in the analyzation/trending of data and information to determine paths for process improvement and potential root cause., • Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles and collaboration with others., • Must have full working knowledge of cGMP regulations., • Exceptional communication, presentation, and interpersonal skills., • Strong Microsoft Word and Excel skills., • Ability to work in a dynamic environment, multi-task, and meet aggressive deadlines., • Ability to work independently, as well as work on larger cross-department projects as a team. Work Environment & Physical Demands, • Professional GMP facility environment with controlled conditions., • Ability to sit or stand for extended periods during training and operations., • Occasional lifting of materials or equipment up to 40 pounds., • Willingness to work inside an ISO7 cleanroom when supporting manufacturing operations. 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 GENALYTE At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, an automated decentralized lab featuring our novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities. WHY WORK FOR US We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career. POSITION SUMMARY The Supervisor, Clinical and Systems V&V is responsible for overseeing Research Scientists and Phlebotomists in day to day activities in the Phlebotomy and Validation team. The Supervisor will take a supportive role in activities relating to method feasibility, verification, validation, and transfer including oversight of change controls, protocol/Work Instruction generation, sample preparation and data evaluations. This position will work closely with the various product development teams to coordinate V&V activities and ensure planning activities are completed prior to initiation of V&V studies. As manager within the Clinical Affairs team, they will execute clinical studies in accordance with IVD clinical guidelines, applicable regulatory requirements, company SOPs, and study protocols. They will participate in the management of budgets and timelines, as well as all the tasks of clinical study and ongoing process of improvement of clinical standard operation procedures, work instructions and tools. A Manager of Clinical Affairs works for all the IVD product lines, including Immunoassay, Hematology and Clinical Chemistry. The Supervisor will interact with Project Managers, Assay Development, Quality and Regulatory to address problems, identify solutions, resolve timelines issues, and communicate conflicting project goals. Works with Manufacturing to set up and optimize production, communicate product manufacturing strategies, new processes, and new competency requirements. Works within our team to optimize downstream testing and to streamline with clinical as appropriate. Provides updates to Management and to Project Teams, when participating in cross-functional teams. Ensures all issues related to the success of the product launch are communicated to the Manager Quality Assurance. ESSENTIAL FUNCTIONS & RESPONSIBILITIES These may include but are not limited to: • Oversee laboratory inventory management, • Actively participates on design teams, understands project goals and timelines, and provides leadership to ensure product launch success, • Actively communicates project status, challenges, concerns, and resource constraints to area management, • Writes design control documentation and executes/oversees associated test and risk management activities, • Maintains project documentation in accordance with internal Genalyte and external regulatory requirements as part of the design control process, • Provides guidance to V&V, R&D or other functions as needed, • Carries out duties in compliance with established business practices and policies, • Provides support and guidance for troubleshooting method issues, • Resolves complex technical problems through teamwork, communication, and application of technical expertise, • Supports improvement verifications, validations, and transfers, • Develops, reviews, or approves execution protocols and group generated data, • Oversee studies, reviews protocol execution, and approves summary reports, • Effectively communicates with support groups across the company, • Maintains high levels of communication with other laboratory teams to support the coordination of shared resources, • Performs evaluations and action-item assignments related to change controls, • Reviews and approves document changes for SOPs and other technical documents, • Ensures group members have and use appropriate engineering controls, safety procedures and PPE. Encourages a strong culture of team and individual safety awareness and accountability, • Coordinates cross-functionally across the site to support project planning and execution, • Ensures an appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed, • Performs analysis and determines appropriate actions in investigations, deviations, CAPAs, and continuous improvement to ensure compliance with all GMP requirements, • Anticipates and troubleshoots issues regarding processes, procedures, and documentation, • Utilizes scientifically sound, risk-based approaches to determine the impact and root cause of issues as they are identified, • Develops and implements corrective actions, • Leads and develops best practices, • Independently supports the assay V&V vision on the project teams Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES • Bachelor’s Degree in Engineering, Science, related field or equivalent, • 2+ years of relevant experience in a pharmaceutical or medical device environment. ISO13485, ISO 62304 and FDA QSR experience., • Experience in development and implementation of standards, procedures, and guidelines in support of validated operational processes., • Ability to clearly articulate design verification and validation process concepts to the business community through written and oral presentations. Knowledge/Skills • Strong analytical and problem-solving skills, • Good organizational skills, and the ability to manage multiple tasks, • Experience in product development and experimental design, • Ability to work within cross functional teams, • Strong communication skills, written and verbal, • Must exhibit professionalism, confidence, maturity, a desire to succeed, proactivity, and self-motivation, • Strong knowledge of relevant analytical tools, • Ability to participate in planning and managing projects, • Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management), • Knowledge of related quality systems regulations and processes, • Appropriate computer skills (e-mail, word processing, statistical, spreadsheet software), • Ability to successfully complete projects while maintaining empathy for the team, • Persuasive, encouraging, and motivating, • Excellent negotiation and conflict resolution skills, • Flexible during times of change, • Ability to work in a startup-like culture and conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities, • Ability to understand and flex to different communication styles of team members and contractors who come from a broad spectrum of disciplines, • Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments Powered by JazzHR jyunjKrCiA

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 Description The Vice President of Quality will establish, lead and develop the quality function, in line with the company’s stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment. Key Responsibilities: • Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical and nonclinical studies, PV vendors, and CROs, • Maintain efficient systems and processes that ensure Contineum and its vendor network comply with GXP standards, • Ensure the appropriate identification, evaluation, and management of risks associated with quality, • Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment., • Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations, • Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle, • Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and external teams to implement corrective and preventive actions, • Lead the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation, • Create and implement risk-based quality strategies that identify and address potential quality risks, • Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues, • Ensuring vendors adhere to relevant quality programs, regulations, and guidelines, and preparing them for regulatory inspections, • Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP and PV activities, • Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations, • Stay updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global GXP/PV regulations and guidance, • Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities, • BS/BA in biology or related Life Sciences discipline, or equivalent experience, • Minimum of 15 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development, • Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines, • Expertise in Quality Management Systems (QMS), • Extensive knowledge of quality risk assessment and management methodologies, with a successful track record in their application and risk mitigation, • Proven experience in establishing and managing a quality organization and GXP and CSV experienced team members, • Track record of success in a biotech start-up or fast-paced, innovative, dynamic environment, with the ability to remain flexible, proactive, resourceful, and efficient, • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment, • Strong management, interpersonal, and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff, • Demonstrated ability to lead and motivate cross-functional teams, • Willingness and desire to “roll up your sleeves” and perform activities and responsibilities to support the team We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $300,000- $350,000. 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. Contineum offers competitive compensation and benefits, including: • 90% employer-covered benefits, • Flexible PTO, • A very generous holiday schedule that includes a week off in August and time off around the winter holidays, • A well-stocked kitchen with snacks and beverages, • Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match., • The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

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 DescriptionCompany 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 agroscience Contract Research Organisation 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 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 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. Job Description This position is Responsible for leading Quality Assurance Department in accordance with vision, values, and strategic goals of the company. It will involve overseeing and facilitating efficient quality operations, assuring consistent client service, implementing laboratory practices as applicable to current regulatory standards, working with client and agency audits and correspondence, maintaining certifications, Quality Assurance policy development, and maintenance, following up promptly on any quality and compliance related issues, and implementing respective CAPA actions to assure adherence to the required quality metrics. Other responsibilities are as follows: • Chairs Quality Management Oversight Meetings to monitor for trends, identify improvements, and assure the effectiveness of the Quality Management System, • Implements, prepares, and presents training programs as required to satisfy regulatory requirements, • Manages Quality Management System, • Applies industry experience to establish and implement best laboratory practices and quality system standards as related to compliance, • Performs QA review and approvals as required, • Maintains current records for required certifications and/or accreditations, • Communicates with client and agency auditors, responds to findings, and effectively addresses concerns or findings, • Provides information for monthly/quarterly reports to senior site management, • Identifies, implements, and assures adherence to effective quality control measures, • Mentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the company, • Leads complex projects through to completion, • Communicates effectively with client staff members, • Performs other duties as assignedQualifications, • Bachelor’s or Master’s degree in Chemistry or closely related science field from a four year college/university or equivalent education and job experience, • At least five years of bio/pharmaceutical chemistry/microbiology/biopharmaceutical experience with some data review responsibilities and a working knowledge of regulatory requirements, • Solid understanding of chemistry/lab practices., • Knowledge of auditing techniques, • Familiarity with at least one scientific technique (HPLC, GC, etc.), • Self-confidence, leadership, ability to reason, make sound decisions, and delegate, • Empathy and sensitivity towards others, • Motivation to excel and inspire excellence in others, • Ability to manage the work of others and see projects through to completion, • Strong communication including verbal, writing, and presentation skills, • Ability to communicate effectively and relate well to people, • Mental and emotional stability and maturity, • Ability to handle personal stress and diffuse stress in others, • Strong organizational skills and ability to handle multiple priorities, • Sets positive example for others, • Dedication to quality, ethics, and customer service, • Pride in appearance, conduct, and company, • Ability to work effectively under pressure to meet deadlines, • Good negotiation and reasoning skills, • Excellent written and verbal communications skills, • Good judgment and tact recognizing and solving problems, • Recognized as understanding, interpreting, and following company policy Additional Information Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply. Target compensation: $80,000-$100,000/year As a Eurofins Lancaster Labs 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 and vacation, personal days, and dental and vision options. To learn more about Eurofins, please explore our website . Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

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 Sr. Process Engineer with 7–11 years of experience to lead the design, optimization, and automation of manufacturing and laboratory processes. This role will serve as a primary Subject Matter Expert (SME) for key cell therapy unit operations and will guide process monitoring, improvement initiatives, technical investigations, and technical transfers within cGMP environments. The Senior Process Engineer will provide strategic and hands-on support across process development, operations, quality, and regulatory functions, driving process robustness, efficiency, scalability, and compliance across client programs. WORK LOCATION: Travel to client sites may be required up to 100 percent, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) • Act as the primary SME for assigned cell therapy unit operations such as cell selection, gene transduction, cell expansion, and cryopreservation within cGMP manufacturing., • Provide Person-in-Plant (PIP) support during critical operations, ensuring real-time technical guidance and issue resolution., • Lead complex deviations and investigations to determine root causes and establish corrective and preventative actions (CAPAs)., • Establish and maintain process control strategies for critical process parameters (CPPs) and critical quality attributes (CQAs)., • Conduct data trending, process performance assessments, and modeling to identify improvement opportunities., • Propose and execute technical projects to optimize yields, reduce cycle times, and enhance process robustness and scalability., • Lead the development, optimization, and scale-up of manufacturing and laboratory processes across upstream, downstream, or formulation operations., • Oversee process automation initiatives, including equipment integration and implementation of advanced control strategies., • Lead commissioning, qualification, and startup of process equipment and automated systems., • Partner with automation, engineering, and operations teams to implement digital tools, process monitoring systems, and data-driven frameworks., • Troubleshoot high-impact equipment, process, and automation issues, providing technical direction to junior staff., • Lead technical transfer of manufacturing processes between development and manufacturing groups or across internal and external sites., • Ensure process consistency, scalability, and alignment with quality system expectations during transfer., • Author, review, and approve technical protocols, reports, memos, SOPs, and change control documentation., • Provide technical data and narrative content for regulatory submissions including IND amendments and CTA filings., • Support the evaluation, integration, and validation of new technologies or systems to ensure scalability, reliability, and operational readiness., • Work closely with Quality Assurance, Manufacturing Operations, Development, and Regulatory Affairs to align on technical strategies and execution plans., • Manage vendor relationships, equipment upgrades, and external technical partnerships. Education • 7–11 years of process engineering experience within biotech, pharmaceutical, or advanced manufacturing environments., • Extensive hands-on experience with automated process equipment such as bioreactors, chromatography systems, filtration skids, or formulation systems., • Strong familiarity with process automation platforms such as DeltaV, Rockwell, Siemens, or SCADA and PLC systems., • Proven experience leading process development, scale-up, equipment integration, and optimization initiatives., • Strong understanding of process engineering fundamentals, mass and energy balances, process control principles, and equipment design., • Ability to interpret and develop P&IDs, engineering drawings, and automation logic., • Advanced data analysis skills, including statistical methods, modeling tools, and engineering software., • Strong communication, leadership, and project management abilities. Physical Demands: Regular use of a computer, keyboard, and mouse; reaching with hands and arms; talking and listening. Frequent walking and sitting; occasional standing, stooping, or kneeling. Must be able to lift and carry objects up to 25 pounds. Requires close vision and ability to adjust focus. Work Environment: Indoor office environment with moderate noise, bright lighting, and typical office conditions. 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. COMPENSATION: The expected salary range for this position is $125,000 to $188000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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 ACROBiosystems is a worldwide leader in developing and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone company in the life science and healthcare industry. We value the fast growth in a global market over a challenging time by excelling through quality, performance, and innovation, empowering our employees with trust, value, and respect, embracing diversity, and encouraging cross-functional collaboration and continuous learning. Job Summary The Regional Marketing Manager is a key strategic leader responsible for driving brand growth and market penetration across the US region. Moving beyond traditional execution, this role focuses on the high-level development of localized marketing strategies and the optimization of our distributor and partner ecosystem. This includes developing, executing, and monitoring local marketing strategies across the US region to optimize marketing events and raise company awareness. The manager must be able to gain a thorough understanding of our products and services, work with a multitude of stakeholders and represent ACROBiosystems in a professional manner while positively shaping the ACROBiosystems’ identity, profile, and visibility within the life science community. This position must also be able to work the occasional night and/or weekend, to provide on-site events and internal team support. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. • Lead the development and execution of regional marketing strategies that align with global brand objectives while maximizing local market penetration and ROI., • Manage and optimize relationships with US-based distributors and partners, providing them with the strategic tools, co-marketing programs, and brand guidance necessary to hit regional sales targets., • Coordinate related logistics related to trade shows/events; connect with different vendors and carriers to ensure the events run smoothly., • Collaborate with digital and creative teams to launch localized, multi-channel campaigns (social, web, email) tailored to regional regulations and cultural nuances., • Conduct comprehensive research on customer behavior and competitor movements to identify market gaps, assess positioning, and inform long-term strategic planning., • Transform complex regional market data and KPI metrics into actionable insights and executive-level presentations for internal stakeholders., • Oversee high-impact regional activations including online and offline channels, ensuring they serve as strategic touchpoints for brand awareness rather than just logistical exercises., • Supervise and mentor regional marketing staff, fostering a culture of professional growth, accountability, and cross-functional collaboration., • Master’s degree in life science or related discipline required., • Advanced degree or MBA preferred., • 5+ years of B2B or B2C marketing experience in the biotechnology or pharmaceutical industry., • Passionate about the life sciences and pharmaceutical industry and aligned with company values., • Excellent written, communication, and presentation skills., • Proficiency in marketing solutions and applications such as Salesforce, Adobe, Canva and Constant Contact, or other similar tools; as well as Microsoft Office especially Excel and PowerPoint., • Strong leadership, stress resistance, with an innovation mindset., • Strong analytical, critical thinking, and problem-solving skills, • Ability to develop strategic vision and execute resulting plans., • Multi-tasking and time-management skills, with the ability to prioritize tasks and meet deadlines., • Project management experience with the ability to coordinate multiple stakeholders globally., • Willing to travel to marketing events and activities across the US.Salary: $90,000-$120,000 base salary + bonus DOE Location: San Diego, CA or San Jose, CA (Hybrid) Work Environment & Physical Demands Office While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment. 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.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 Pharmaceuticals is seeking a Director of Pharmacometrics and Clinical Pharmacology to provide strategic and scientific leadership across the company's clinical development programs. This senior-level role is responsible for advancing pharmacometric and clinical pharmacology strategies to support the global development and regulatory submission of Arrowhead's leading siRNA therapeutics. The Director will play a critical role in clinical trial design, data analysis, regulatory documentation, and cross-functional decision-making, ensuring that dosing strategies and clinical pharmacology plans are scientifically rigorous and aligned with regulatory expectations. Responsibilities • Provide leadership and subject matter expertise in pharmacometrics and clinical pharmacology across Arrowhead's development portfolio., • Contribute to global regulatory submissions, including marketing applications for siRNA-based therapeutics., • Design and support clinical trial protocols, including dose selection and optimization strategies., • Author and review clinical pharmacology sections of Investigational Brochures (IBs), Clinical Study Reports (CSRs), and other regulatory documents., • Conduct and oversee analysis of clinical and translational PK/PD data, including population PK/PD modeling., • Communicate analysis results, interpretation, and strategic recommendations to project teams in a timely and effective manner., • Develop clinical pharmacology plans and propose dosing strategies across development stages., • Doctoral degree (PhD, PharmD) in pharmacokinetics, pharmacology, pharmaceutical sciences, or a related discipline., • 8 years of post-degree experience in the pharmaceutical or biotechnology industry in pharmacometrics or clinical pharmacology roles., • Demonstrated expertise in population PK/PD modeling, with proficiency in standard software platforms such as NONMEM. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Job Summary: The Associate Director, GxP Quality Systems is responsible for the development, implementation, and ongoing management of the company’s Quality Management System (QMS) supporting GxP activities. This role ensures that quality processes and systems effectively support compliant operations across clinical, regulatory, and operational functions. Key Responsibilities: GXP Quality Management System Oversight • Develop, implement, and maintain the company’s GxP Quality Management System supporting clinical development and broader GxP activities., • Provide governance for core quality processes including document management, training administration, and quality event processes (e.g., deviations, change control, and CAPA)., • Ensure quality policies, procedures, and standards support compliance with applicable GXP regulations, guidelines, and other relevant regulatory requirements., • Maintain oversight of electronic quality management systems (eQMS), including administration, configuration, and alignment with company quality processes., • Monitor the effectiveness of quality processes and drive continuous improvement initiatives within the QMS., • Develop and maintain quality metrics and dashboards to evaluate compliance trends and system performance., • Provide guidance and training to internal teams on quality system processes and expectations., • Collaborate with clinical operations, regulatory, CMC, and other functional teams to support implementation of quality processes., • Collaborate with the GMP and GCP Quality functions to support quality oversight of manufacturing and clinical development activities., • Support the development and maintenance of clinical quality procedures and standards., • Assist with inspection readiness activities related to manufacturing, clinical trials and regulatory inspections., • Support internal and external audit programs, including preparation, coordination, and follow-up activities., • Participate in vendor qualification and oversight activities where quality system processes are involved., • Bachelor’s degree in a scientific discipline or related field., • 6+ years of progressive experience in Quality Assurance or Quality Systems within the pharmaceutical or biotechnology industry., • Experience supporting clinical development programs and familiarity with GMP and/or GCP regulations and guidelines., • Experience working with electronic Quality Management Systems (e.g., Veeva, TrackWise, or similar platforms)., • Experience working in a virtual or outsourced development environment is preferred., • Strong organizational, analytical, and problem-solving skills. The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Recruiters and Agencies: BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

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 Corporate Compliance Officer is responsible for leading, developing, and overseeing the company’s comprehensive corporate compliance program, with a primary focus on internal compliance, trade compliance, reporting requirements, document retention, quality compliance, anti-corruption, data privacy and industry standards in the pharmaceutical/biotech sector. Reporting to the Executive Vice President-General Counsel, this role partners closely with Commercial, Clinical, CMC, Quality, Regulatory, and Operations to ensure all company activities align with applicable laws, regulations, contractual obligations, and ethical standards. The ideal candidate is a seasoned compliance professional with deep pharmaceutical or biotech experience, proven leadership in building and managing compliance programs, with experience in international trade compliance involving Europe and/or Japan (e.g., export controls, sanctions, trade regulations, customs, or cross-border technology transfer).Responsibilities • responsibilities include but are not limited to: Compliance Program Leadership & Governance, • Design, implement, maintain, and continuously improve Capricor’s corporate compliance program, including policies, procedures, risk assessments, monitoring, and auditing frameworks., • Assist in the development, implementation, and updating of corporate policies, SOPs, and legal processes., • Lead the development and delivery of compliance training and communications across the organization., • Oversee compliance monitoring, internal investigations, corrective actions, and reporting to senior leadership and the Board as needed., • Maintain and enhance compliance tools, playbooks, dashboards, and processes to support scalability. Commercialization Readiness, • Provide strategic compliance guidance on commercialization planning, including distribution, supply chain, marketing, field operations, patient support programs, and HCP/payer engagements., • Ensure promotional materials, scientific exchange, pre-approval communications, medical affairs activities, and vendor interactions comply with FDA, EMA, Sunshine Act, Anti-Kickback Statute, False Claims Act, and other relevant laws., • Review commercial, medical, and vendor-related materials and activities for regulatory and compliance risk. International Trade Compliance (Europe and/or Japan), • Oversee compliance with U.S. and foreign export controls, sanctions regimes (OFAC, EU, Japan), customs regulations, and trade agreements relevant to Capricor’s operations and partnerships in Europe and/or Japan., • Manage classification, licensing, and documentation for cross-border transfers of technology, biological materials, data, and equipment., • Conduct due diligence and risk assessments for international transactions, partnerships, and clinical/commercial activities in these regions. Third-Party & Vendor Compliance Oversight, • Lead third-party risk management, including anti-corruption due diligence (FCPA/UK Bribery Act/Japanese regulations), screening, contracting requirements, and ongoing monitoring., • Collaborate with Procurement, CMC, Manufacturing, Quality, and International teams to ensure third-party obligations meet compliance and operational standards., • Address vendor compliance issues, disputes, and audit findings. Corporate, Operational & Risk Support, • Partner on data privacy (GDPR, CCPA, etc.), confidentiality, information governance, and cybersecurity compliance initiatives., • Support audit readiness, regulatory inspections, and third-party assessments., • Advise on emerging regulatory and compliance trends in the pharma/biotech industry and communicate implications to stakeholders.Requirements, • Bachelor’s degree required; J.D. preferred., • 10+ years of progressive compliance experience in the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role overseeing compliance programs., • Demonstrated experience managing international trade compliance matters involving Europe and/or Japan (export controls, sanctions, customs, technology transfer, or equivalent)., • Deep knowledge of compliance laws and industry codes., • Experience supporting commercialization and launch-stage activities in biotech/pharma strongly preferred., • Proven ability to build and lead compliance functions in dynamic, fast-paced environments., • Strong risk assessment, investigation, and issue-management 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 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, Quality Assurance & Quality Systems 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 • 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., • 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., • 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., • 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., • 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., • 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., • 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 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. 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 Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai's portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. Your next role as a Miracle Maker Maravai LifeSciences is seeking a #MiracleMaker to join our Process Development team as a Manager, Production Operations & GMP. As a Manager, Production Operations & GMP you will lead a team of technical subject matter experts and GMP support staff to ensure efficient, compliant, and innovative manufacturing operations. This role provides technical leadership for production processes, supports technology transfers, and drives continuous improvement initiatives. Responsibilities include coaching and mentoring manufacturing teams, sustaining process knowledge, optimizing workflows, and overseeing cleanroom operations and GMP compliance. Acting as a technical liaison, the Manager will collaborate cross-functionally with Manufacturing, Quality, R&D, Supply Chain, and Commercial teams to support new product introductions, customer projects, and investigations. This position requires strong expertise in biologics manufacturing, cleanroom operations, and GMP standards, with the ability to operate semi-independently and deliver solutions in a fast-paced CDMO environment. How you will make an impact: • Lead cGMP CDMO technology transfer projects between customers and internal manufacturing teams for mRNA production., • Manage tech transfer activities for NPIs from R&D/Process Development to GMP manufacturing, ensuring reproducibility and high quality., • Provide technical oversight during technology transfer and manufacturing campaigns; assess and optimize process parameters for scalability., • Design and execute experimental protocols; analyze data and prepare technical reports., • Oversee GMP production and cleaning operations, ensuring compliance with regulatory standards and company requirements., • Review and approve controlled documents, batch records, cleaning documentation, and GMP documentation (SOPs, deviations, CAPAs, change controls)., • Train, schedule, and supervise production and support staff; maintain training matrices and job descriptions., • Coach and mentor manufacturing associates in process understanding, troubleshooting, and project management., • Serve as a technical SME for internal teams and customers, supporting investigations and inquiries., • Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Engineering, and R&D to meet production schedules and resolve issues., • Drive continuous improvement initiatives using Lean Six Sigma and statistical tools; lead root cause analyses for critical investigations., • Stay current with industry trends in modern manufacturing technologies (automation, disposable systems)., • Support audits, change controls, and Quality Risk Management programs., • Ph.D. with 2+ years, M.S. with 4+ years, or B.S. with 6+ years of experience in a scientific field (Biology, Chemistry, Biochemistry, or Engineering)., • Minimum 4–6 years of relevant experience in biotech or pharmaceutical development, including at least 2 years in a supervisory or leadership role., • Strong knowledge of cGMPs, 21 CFR 210/211, 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements., • Experience leading technology transfers, process qualification, and validation., • Familiarity with biologics manufacturing, CDMO operations, and ISO 14644 cleanroom classifications., • Ability to draft and review GMP documentation (SOPs, batch records, deviations, CAPAs, change controls, validations)., • Experience with electronic quality systems and ERP platforms (e.g., NetSuite)., • Excellent written and verbal communication skills with experience supporting strategy development and implementation., • Proven ability to manage and mentor teams, work cross-functionally, and drive strategic initiatives., • Strong collaboration skills and ability to influence across departments., • Lean Manufacturing or Six Sigma experience preferred., • Ability to implement processes that deliver measurable results and adapt best practices in novel technology environments. #LI-Onsite The benefits of being a #MiracleMaker: • You have the potential to change, improve, and save lives around the world., • You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans., • We offer comprehensive medical plans and HSA/FSA options., • Fertility & family planning assistance., • A variety of additional optional benefits and insurance options, including pet insurance., • Retirement contributions. To view more opportunities to become a #MiracleMaker, visit our career site at Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Click here to view Maravai LifeSciences Privacy Notice HIRING SCAM ALERT Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: • Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.), • Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment., • Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment. If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at . If you believe you have been a victim of fraud, you can report this activity at: or .

Job Description Onsite: San Diego 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 QA Consultant (GxP) to join our team in San Diego, CA., • In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions., • You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams. Key Responsibilities • Support concurrent activities for legacy Quality systems during QMS integration and system migration phases., • Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems., • Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls., • Operate and support legacy Quality systems during the transition to new platforms., • Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records., • Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA)., • Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records., • Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS)., • Support continuous improvement efforts for events within EDMS and LMS., • Work with document owners to ensure timely periodic review of procedures., • Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools., • Generate and trend quality metrics, communicating findings to leadership., • Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans., • Review and approve paper-based quality documentation and electronic quality records., • Promote a culture of quality, teamwork, and accountability with a patient-first mindset., • Align daily activities with department goals and company values., • Ability to lift up to 20 pounds as needed. Qualifications • Education: Bachelor’s degree in Life Sciences 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). 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) and Learning Management Systems (LMS) such as ComplianceWire or Qualio., • Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word). Competencies: • Exceptional written and verbal communication skills., • Strong attention to detail and ability to manage multiple projects simultaneously., • Proven ability to work independently and collaboratively in a fast-paced, dynamic environment., • Experience developing training materials and delivering training to employees., • Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents. The hiring range for this position is $50 to $60 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 Description 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., • 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. 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)., • 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 $75 to $85 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.

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: $180k - $200k

Job Description GxP Quality Assurance Consultant ROCGJP00039852 • Hourly pay: $60/hr, • Worksite: Leading biotechnology company (San Diego, CA 92121 - Onsite), • W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL GxP Quality Assurance Consultant Responsibilities: • Ensure compliance with regulatory requirements while supporting site-specific needs., • Support concurrent activities for legacy Quality systems during QMS integration and system migration phases., • Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems., • Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls., • Operate and support legacy Quality systems during the transition to new platforms., • Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records., • Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA)., • Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records., • 8+ years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred)., • Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered)., • 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) and Learning Management Systems (LMS) such as ComplianceWire or Qualio., • Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word)., • Strong attention to detail and ability to manage multiple projects simultaneously., • Experience developing training materials and delivering training to employees., • Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents., • Standard hours 8am to 5pm - may need to have some flexibility to work earlier/late as needed.

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 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, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor’s product lifecycle, with primary accountability for Deramiocel’s BLA pathway and advancement of other pipeline candidates from development through potential commercial approval and post-approval maintenance. Reporting to and collaborating closely with the VP of Regulatory Affairs, this role develops and executes CMC regulatory strategy, ensures compliance with global requirements (FDA, ICH, EMA), identifies and mitigates risks, and partners with cross-functional teams (CMC Development, Manufacturing, Quality, MSAT, Supply Chain, and others) to drive successful submissions, health authority interactions, and company objectives in a fast-paced, mission-driven biotech environment.Responsibilities • Develop, own, and execute CMC regulatory strategy across the product lifecycle (from development through commercial and post-approval phases) in alignment with global regulatory requirements and Capricor’s overall regulatory and business goals., • Oversee and lead the preparation, authoring, review, final approval, compilation, and submission of CMC sections for major regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, MAAs, responses to queries/information requests, and post-approval changes)., • Proactively identify risks related to documentation, content, quality, or timelines for global CMC submissions; collaborate with Manufacturing, Quality, Process Development, MSAT, and other departments to ensure timely delivery of approved, high-quality technical source documents., • Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, process validation summaries, comparability protocols, and deviation/investigation reports., • Foster CMC regulatory alignment and phase-appropriate readiness by collaborating with supporting departments (Manufacturing, Quality Assurance, MSAT, Supply Chain, Commercial, etc.) to support development, scale-up, validation, and commercial readiness activities., • Review and approve product labeling with responsibility for CMC-related claims, product descriptions, manufacturing statements, and participate in Advertising & Promotion review committees as needed., • Manage, mentor, and develop regulatory affairs professionals; provide leadership, oversight, accountability, and support to ensure high-performance deliverables and team growth., • Serve as the primary CMC interface with health authorities (primarily FDA for biologics/cell therapies, potentially EMA) for submissions, negotiations, formal meetings (e.g., Type meetings, pre-BLA interactions), and responses to queries or deficiencies (including addressing any CMC-related items from the Deramiocel CRL)., • Monitor global regulatory trends, guidelines, and precedents (e.g., ICH Q updates, FDA guidance on CMC for cellular/gene therapies, advanced therapies) and adapt Capricor’s CMC strategies proactively to maintain compliance and competitive advantage., • Contribute to regulatory risk assessments, gap analyses, contingency planning, and inspection readiness for CMC aspects and manufacturing sites., • Perform such other duties as may be assigned from time to time.Requirements, • Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) preferred., • 8+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, including significant experience with biologics, cell therapies, or regenerative medicine products; commercial-stage product experience (post-approval lifecycle management) highly preferred., • Proven track record of preparing, authoring, leading, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including successful responses to agency queries, deficiencies, or Complete Response Letters., • In-depth knowledge of global regulatory requirements and guidelines relevant to CMC for biologics and cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, process validation, stability, comparability, potency assays)., • Experience supporting BLA or similar submissions for advanced therapy products, with familiarity in addressing CMC issues in late-stage reviews or post-CRL scenarios preferred., • Strong project management skills with the ability to lead multiple complex projects, manage timelines, resources, and cross-functional dependencies in a dynamic environment., • Exceptional communication skills (written and verbal) for effective interaction with internal teams, external partners, and health authorities, including authoring clear regulatory documents and presenting strategies., • Proficiency in regulatory information management systems and tools (e.g., Veeva RIM, document authoring/publishing software)., • Demonstrated leadership abilities, including mentoring and developing team members, fostering collaboration, and driving accountability., • Ability to work strategically and independently while thriving in a collaborative, fast-paced setting.Work Environment / Physical Demands, • Primarily office-based with tasks involving regulatory documentation, strategy development, and cross-functional/global coordination., • Requires prolonged periods of computer use for drafting, reviewing, compiling, and reporting on CMC documents and submissions., • May involve lifting office materials up to 15 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 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.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 Provide strategic leadership for the design, implementation, and continuous improvement of the company's data integrity program across GxP operations supporting clinical and commercial pharmaceutical and combination products. Define and oversee company-wide governance frameworks, policies, and requirements to ensure alignment with global data integrity regulations and ALCOA++ principles. Serve as a cross-functional leader and subject matter expert, partnering across the organization to embed data integrity principles and compliance into systems, processes, and culture. Responsibilities • Lead the development, implementation, and continuous improvement of data integrity policies, procedures, and program elements in alignment with global regulatory requirements., • Establish and oversee data integrity governance programs, partnering cross-functionally to drive strategic initiatives and foster a culture of data integrity., • Develop and maintain systems for data integrity impact assessments, risk evaluations, and remediation plans, ensuring timely completion of commitments., • Evaluate data management, documentation, and record control practices across systems and formats to ensure compliance with data integrity requirements., • Implement and maintain processes to assess computerized systems, software, and equipment for compliance with 21 CFR Part 11, Annex 11, and related guidance., • Lead and oversee comprehensive data integrity audits and assessments to identify risks, gaps, or discrepancies, and lead mitigation and remediation activities., • Drive corrective and preventive actions and process improvement initiatives to strengthen data integrity controls and system reliability., • Develop, analyze, and report data integrity metrics and key performance indicators to senior leadership., • Design and deliver training programs to promote data integrity awareness and ensure consistent understanding across the organization., • Provide subject matter expertise and support during regulatory inspections and partner audits, articulating data integrity program elements and strategy., • Monitor global regulations, emerging guidance, and best practices through active engagement with relevant professional organizations (e.g., ISPE, PDA)., • Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline., • Minimum of ten (10) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including at least five (5) years in a leadership role with increasing responsibility., • Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards., • Demonstrated expertise with ALCOA++ principles, data lifecycle management, and data governance frameworks., • Proven experience applying 21 CFR Part 11, Annex 11, and other relevant regulations and guidance governing data integrity and information security., • Strong understanding of information technology and data management systems, including system validation, security, and enterprise data governance., • Proven ability to lead complex, cross-functional projects and build effective partnerships to advance data integrity and compliance objectives, demonstrating strong organizational, planning, and prioritization skills., • Strategic thinker with demonstrated success in driving continuous improvement, innovation, and proactive risk management., • Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels., • Advanced degree preferred., • Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent). California pay range $180,000—$210,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy 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 Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 Clinical Data Scientist will play a critical role in analyzing and interpreting clinical trial data, developing scientific materials, and supporting clinical development strategy across Arrowhead's pipeline. This individual will be part of the Clinical Development team and work with Biostatistics, Medical Writing, and other cross-functional R&D teams to translate complex datasets into meaningful scientific insights that inform internal decision-making, regulatory strategy, and external communication. This position requires a PhD-trained scientist with statistical knowledge, analytical capabilities, scientific storytelling skills, and the ability to operate in a fast-paced biotech environment. This is a fulltime, onsite position based from Arrowhead's Corporate Headquarters in Pasadena, CA or San Diego, CA. Responsibilities Clinical Data Analysis & Scientific Interpretation • Perform in-depth clinical data analyses to support ongoing studies and development programs., • Interpret clinical datasets and translate findings into clear, actionable insights., • Develop internal presentations and communicate results to key stakeholders, including senior leadership., • Identify trends, signal detection insights, and emerging data patterns to support program strategy., • Draft early-stage scientific abstracts, • Prepare and refine slide decks summarizing clinical data for internal and external audiences., • Support development of scientific narratives aligned with emerging data., • Assist Clinical Development with protocol input and clinical trial design considerations., • Contribute to endpoint selection, subpopulation strategy, and exploratory analyses., • Support preparation for key data readouts and milestone events., • Partner with Biostatistics to ensure appropriate analytical approaches., • Collaborate with Clinical Operations and Data Management to ensure data quality and readiness., • Support Medical Affairs and other functions in understanding emerging clinical insights., • PhD in a biological, biomedical, or medical discipline., • 3+ years of experience in biotech, pharmaceutical, academic translational research, or clinical data analysis roles., • Strong experience analyzing and interpreting clinical data., • Background in medical writing, clinical data science, or translational research., • Experience supporting clinical trial design., • Experience in early-stage development programs., • Familiarity with statistical tools (e.g., SAS, R, Python) or data visualization platforms, • Experience preparing scientific presentations and slide decks for internal stakeholders., • Experience drafting or contributing to scientific abstracts or publications., • Excellent written and verbal communication skills., • Strong analytical thinking and ability to synthesize complex datasets. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our CMC Department as a Clinical Supply Chain Specialist and work as part of a team to drive success. The Clinical Supply Chain Specialist, Clinical Supplies will support the planning, coordination, and execution of global clinical supply activities for company-sponsored clinical trials. This role will partner cross-functionally with Clinical Operations, CMC, Quality, Regulatory, and external vendors to ensure uninterrupted supply of investigational product (IP) to clinical sites while maintaining compliance with GxP, regulatory, and company requirements. The ideal candidate is detail-oriented, highly organized, and experienced in managing clinical supply logistics in a fast-paced pharmaceutical or biotech environment. Essential Responsibilities: • Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability., • Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company., • Support end-to-end clinical supply chain activities including forecasting, planning, packaging, labeling, distribution, returns, and reconciliation of investigational product., • Coordinate with internal stakeholders and external CMOs, depots, and logistics vendors to ensure timely manufacturing and delivery of clinical supplies., • Maintain and track inventory levels at depots and sites; proactively identify and mitigate potential supply risks., • Generate and manage clinical supply forecasts and resupply strategies based on enrollment projections, drug product expiry dates, and study timelines., • Support creation and review of packaging and labeling specifications in alignment with study protocols and regulatory requirements., • Manage Interactive Response Technology (IRT/RTSM) supply settings and ongoing updates in collaboration with Clinical Operations and vendors., • Prepare and review shipment documentation and ensure compliance with import/export and country-specific requirements., • Reconcile clinical supplies, including returns, destructions, and accountability documentation., • Contribute to development and continuous improvement of SOPs, work instructions, and supply chain processes., • Ensure all activities comply with GCP, GMP, and applicable regulatory guidelines., • Maintain accurate documentation and support audits and inspections as needed., • Provide Operational support services to CMC development and manufacturing functions., • Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level., • Maintain all appropriate corporate standards for facility safety and hazardous material management. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Bachelor’s degree in supply chain, life sciences, or related field., • BS with 3 years of experience or MS with ½ years of experience in clinical supply chain, clinical operations, or pharmaceutical logistics., • Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • Working knowledge of GxP requirements and global clinical trial supply practices., • Knowledge of clinical trial material and/or investigational drug product, • Experience coordinating with CMOs, depots, and third-party logistics providers., • Familiarity with IRT/RTSM systems and clinical supply management tools., • Strong organizational skills with the ability to manage multiple studies and priorities simultaneously., • Experience supporting global, multi-site clinical trials (Phase I–III)., • Understanding of temperature-controlled shipping and cold chain management., • Experience with import/export documentation and international shipping regulations., • Must be able to work independently with supervision as needed., • Proficient at working independently as well as in cross-functional team settings, • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Data: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • Recruiters & Staff Agencies: ADARx Pharmaceuticals (ADARx) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to ADARx or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of ADARx and the Company will not owe any referral or other fees with respect thereto., • Compensation: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation: Includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Conditional Offer of Employment: Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Be Part Of A High-Performing Team: Join a mission-driven biopharmaceutical organization committed to improving the lives of patients facing serious and rare diseases. This is an opportunity to support critical laboratory and manufacturing environments where technology reliability, compliance, and precision directly enable scientific progress and operational success. The team works in close partnership with Quality, Laboratory, Manufacturing, and IT leaders in a highly collaborative environment that values technical ownership, thoughtful execution, and strong alignment to mission and culture. What’s In Store For You: • Exposure to complex, qualified infrastructure supporting research, development, QC, and clinical operations, • Opportunity to take ownership of business-critical IT/OT systems in a visible, high-impact role, • Close collaboration with cross-functional stakeholders across IT, QA, QC, lab operations, and manufacturing, • Own and support qualified on-prem infrastructure across multiple operational sites, including laboratory, manufacturing, and warehouse environments, • Provide hands-on support for firewalls, Cisco switching, physical and virtual server environments, backup, replication, and related infrastructure platforms, • Troubleshoot network communication issues across segmented environments, including firewall policy, port, DNS, and connectivity analysis, • Help evaluate, integrate, and support new systems and vendor solutions within tightly controlled infrastructure environments, • Maintain validated systems in alignment with GxP expectations, change control practices, and internal quality requirements, • Partner with QA, QC, and department stakeholders to execute infrastructure changes without compromising system qualification or compliance status, • Support lifecycle management activities including SOP updates, maintenance documentation, deviation support, and ongoing system administration, • Contribute to compliant infrastructure operations supporting laboratory, research, development, clinical manufacturing, and QC needs, • Bachelor’s degree in Information Technology, Computer Science, Engineering, or equivalent practical experience, • 7+ years of hands-on experience in infrastructure engineering or systems engineering roles, • Strong experience with Cisco switching, firewalls, VMware virtualization, and backup/replication technologies, • Proven ability to troubleshoot firewall communication, segmented network traffic, and infrastructure connectivity issues, • Experience supporting GxP-regulated environments such as biotech, pharmaceutical, laboratory, manufacturing, or other highly controlled operations, • Strong understanding of change control, SOP-driven support, validation-minded infrastructure administration, and regulated lifecycle processes, • Experience working with QA/QC and regulated stakeholders in environments subject to inspection and procedural rigor, • Ability to balance technical problem-solving with strong documentation discipline and attention to detail, • Comfortable operating as a senior individual contributor with a high degree of ownership and autonomy #dice

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., • 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.