Pharmaceutical compliance jobs in San Diego, California - Page 2Crear alertas

Job Description Job Summary: The Regulatory Manager will support and execute the planning, preparation, and submission of regulatory documents to global health authorities. In this role, you will support regulatory project planning, timelines, communications, and ensure successful regulatory submissions and deliverables on time. You will help maintain the internal systems and processes that enable efficient regulatory execution. This position is ideal for someone who thrives in a fast-paced, collaborative biotech environment and wants to contribute directly to bringing innovative therapies to patients. Key Responsibilities: • Manage submission timelines and coordinate document deadlines across Regulatory, Clinical, CMC, Nonclinical, and Quality functions, • Prepare, review, format, and publish high quality regulatory documents (e.g., IND/CTA, amendments, DSURs, meeting packages, eCTD modules) for FDA and other global regulatory agencies, • Manage project communication and stakeholder expectations, providing transparent status updates and risk identification, • Experience or familiarity with eCTD publishing systems and document management platforms (e.g., Veeva Vault, Egnyte, SharePoint), • Conduct technical quality checks, bookmarking, hyperlinking, and ensuring compliance with eCTD and regional requirements, • Maintain submission archives and lifecycle management in accordance with regulatory guidance and internal SOPs, • Track agency correspondence and commitments; assist in preparing responses to health authority requests, • Support development and continuous improvement of regulatory processes, templates, and standards, • Assist with regulatory intelligence monitoring, • Support regulatory authority interactions, • Bachelor's or higher degree in a scientific discipline, • Minimum of 5 years of experience in regulatory operations, regulatory affairs, or eCTD publishing within the biotech/pharmaceutical industry, • Strong attention to detail, organizational skills, and ability to manage multiple tasks under tight timelines, • Excellent written and verbal communication and interpersonal skills, • Experience in a small or early-stage biotech environment, • Strong knowledge of global investigational submission standards and processes (eCTD, FDA/EMA requirements, ICH guidelines), • Familiarity with regulatory publishing tools (e.g., Lorenz DocuBridge, Veeva RIM, GlobalSubmit, eCTDmanager) and document management systems We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $138,000- $148,000. 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 DescriptionCompany Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description THE POSITION: Medical Information is a critically important customer-facing function that supports the safe and effective use of pharmaceutical company products by providing timely, scientifically balanced, evidence based, nonpromotional information in response to unsolicited requests from healthcare professionals, patients, caregivers, and payers. Medical Information also plays an important role in post-marketing handling of adverse events and product complaints. As part of the Medical Information Contact Center (MICC) team, this position delivers industry-leading services, which include Contact Center staffing for responding to product information requests, identifying and handling of adverse events and/or product quality issues, and medical writing as needed to generate written response for use in response to medical questions received. This position requires clinical and therapeutic knowledge, critical and analytical thinking, and customer/patient-centric approach. Medical Information Specialists typically support multiple pharmaceutical clients, multiple products, and multiple therapeutic areas. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: MEDICAL INFORMATION SUPPORT • Respond to medical information inquiries from physicians, pharmacists, nurses, and other health care professionals, consumers, and payers. Utilize medical information skills to identify, research, and critically evaluate medical literature to create responses to medical information inquiries., • Utilize writing skills for adverse event and product complaint narrative during intake as well as medical inquiry custom responses., • Handle requests across multiple channels and platforms (phone, email, CRM, chat, etc.), • Identify adverse events and product complaints during interactions with customers. Perform intake sufficient to generate adverse event and product complaint reports in compliance with EVERSANA-MICC and client standard operating procedures. Knowledge of FDA’s postmarketing adverse event reporting regulations and safety terminology. Ability to make accurate assessments regarding what information needs to be obtained and level or depth of information to be collected., • Coordinate processes necessary for responding to product quality-related complaints. This process may involve interactions with personnel in the following departments: Quality Assurance, Regulatory Affairs, and the complainant., • Maintain product, therapeutic area, and client specific requirements knowledge., • Ensure good documentation, high quality, and excellent customer service., • Medical writing and Medical Information content development. Provide medical writing to assist in drafting of Medical Information response documents [FAQs, Scientific Response Documents (SRDs), Custom Response Documents (CRDs)] and/or work collaboratively with medical writing team to develop these materials.  Staffing at scientific medical affairs booths., • On-call responsibilities on an as assigned basis. EXPECTATIONS OF THE JOB: • Metrics: Maintain and contribute toward process improvement which positively impacts metrics associated with activities of the Medical Communications l Contact Center; metrics are subject to change annually or more often as deemed necessary., • Customer Services: Maintain and improve customer services associated with activity of the Medical Communications Contact Center., • Hours: Able to work full time and be flexible with work scheduling as required by clients and management. An individual in this position must be able to successfully perform the expectations listed above. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. • Education: Advanced healthcare degree (preferred PharmD or higher)., • Education: Advanced healthcare degree (preferred PharmD or higher)., • Licensure: Pharmacist license., • Experience and/or Training: Experiences in a Contact Center and Pharmaceutical industry environment., • Technology/Equipment: Technology proficiency in the areas of telephony, Medical Information database, Microsoft Office, and video conference platforms., • Knowledge: Therapeutic expertise. Ability to critically evaluate medical literature. Medical Information contact center systems and processes., • Experience in Drug Information or a specialty area, particularly in Oncology, Hematology, Immunology, rare disease, Neurology, Cardiology, or other specialty., • Positive Attitude and Energy: Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through her/his attitude., • Communication Skills: Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate., • Innovator: Transforms creative ideas into original solutions that positively impact the company’s performance. The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Additional Information OUR CULTURAL BELIEFS: Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and empower others to act now. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful and timely dialogue. Embrace Diversity I create an environment of awareness and respect. Always Innovate I am bold and creative in everything I do. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

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 Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor’s product lifecycle, with a primary focus on supporting the BLA pathway for Deramiocel and advancing other pipeline candidates from development through potential commercial approval and post-approval maintenance. This role supports the development and implementation of CMC regulatory strategy, ensures compliance with global regulatory requirements (including FDA, ICH, and EMA guidelines), and partners closely with cross-functional teams (e.g., CMC Development, Manufacturing, Quality Assurance, Clinical, and Regulatory) to enable timely submissions, successful interactions with health authorities, and achievement of company objectives in a dynamic biotech environment.Responsibilities • Support the development and execution of CMC regulatory strategy across the product lifecycle (development through commercial and post-approval) to ensure regulatory compliance and alignment with global requirements., • Lead the preparation, authoring, review, compilation, and submission of CMC sections for regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, responses to information requests, and post-approval changes)., • Collaborate with internal CMC, Manufacturing, Quality Assurance, Process Development, and other supporting departments to ensure timely generation, review, and approval of source documents required for regulatory submissions (e.g., stability data, comparability protocols, process validation reports)., • Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, validation master plans, and deviation investigations., • Interface directly with health authorities (primarily FDA, potentially EMA) for CMC-related submissions, negotiations, meetings (e.g., Type meetings, pre-submission interactions), and responses to queries or deficiencies (including addressing any outstanding CMC items from prior BLA feedback)., • Monitor evolving global regulatory changes, guidelines, and precedents (e.g., ICH updates, FDA biologics guidance for cell therapies) and assess impacts on Capricor projects, providing proactive recommendations to leadership., • Contribute to regulatory risk assessments, gap analyses, and contingency planning for CMC aspects of submissions and lifecycle management., • Support inspection readiness activities related to CMC documentation 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., • 5+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, preferably for biologics, cell therapies, or advanced therapy medicinal products (ATMPs)., • Demonstrated experience preparing, authoring, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including responses to agency queries., • Solid knowledge of global regulatory requirements and guidelines relevant to CMC for biologics/cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, comparability, process validation, stability)., • Experience supporting BLA or similar submissions for regenerative medicine products, with familiarity in addressing CMC deficiencies or Complete Response Letters preferred., • Strong project management skills with the ability to manage multiple projects, timelines, and priorities in a fast-paced environment., • Excellent communication skills (written and verbal) for effective interaction with internal stakeholders, external partners, and health authorities., • Proficiency in regulatory document management systems and tools (e.g., Veeva RIM, document authoring software)., • Ability to work independently while collaborating cross-functionally with scientific, manufacturing, and quality teams.Work Environment / Physical Demands, • Primarily office-based with tasks involving regulatory documentation, strategy development, and cross-functional 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 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. Salary Description: $185k-$250k

Job DescriptionThe Clinical Trial Manager will play a pivotal role in the strategic implementation and execution of clinical trials from study start-up to close-out. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs., • Ensure inspection readiness by maintaining comprehensive study documentation and files., • Organize and lead study and departmental meetings, including minute-taking and document archiving., • Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings)., • Ensure team compliance with study-specific training and perform TMF reviews for completeness., • Support clinical sites in audit and inspection preparation., • Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements., • Monitor subject and site activity/metrics and perform quality checks across study components., • Proactively identify, troubleshoot, and escalate issues impacting deliverables., • Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation., • Collaborate with CROs to ensure timely collection and archiving of TMF documents., • Partner with regulatory affairs on essential document submissions., • Support study close-out activities including TMF and drug reconciliation and CSR readiness., • Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads., • Participate in process improvement and quality initiatives related to study execution., • Other duties as deemed necessary.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor’s degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered., • Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out., • Global clinical trial management experience, especially in the EU, highly desirable., • Strong working knowledge of ICH/GCP regulations., • Proficiency with electronic systems such as eTMF, CTMS, EDC, etc., • Ability to work independently and thrive in a collaborative team environment., • Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset., • Excellent interpersonal, written, and verbal communication skills., • Proficiency in MS Office and comfort with technology. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. 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 Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Position: Business Development Director Location: Onsite - San Diego, California Position Type: 5 days Onsite Exempt Position Salary Range: $100,000-$200,000 Job Summary: We are seeking an experienced and strategic Business Development Director to drive growth, partnerships, and revenue expansion within the biotechnology industry. This role is responsible for identifying new business opportunities, cultivating relationships with key stakeholders, and leading strategic initiatives to enhance market presence. The ideal candidate will have a strong background in biotech, life sciences, or pharmaceuticals, along with expertise in strategic partnerships, licensing, and market expansion. Key Responsibilities: • Strategic Planning & Commercialization, • Develop and execute business strategies aligned with corporate objectives., • Lead full business cycles, including market entry, product expansion, and transformation during decline phases., • Implement pricing strategies, optimize channel mix, and allocate resources to balance short-term profitability with long-term growth., • Example: Created a 3-year growth roadmap that elevated market share from Top 5 to Top 2., • Team Leadership & Organizational Development, • Build and restructure medium-to-large teams, ensuring a strong talent pipeline., • Lead teams through cultural and structural mechanisms rather than direct authority., • Revitalize legacy teams to drive engagement and prevent stagnation., • Example: Transformed a commission-based sales team into a triad model (sales + solution + delivery), increasing efficiency by 50%., • Resource Integration & Ecosystem Building, • Establish and manage strategic partnerships across industries and regions, including government relations, supply chain alliances, and capital partnerships., • Design win-win partnership frameworks to enhance business growth., • Leverage external opportunities such as policy incentives, industry expos, and media PR., • Example: Partnered with industry associations to establish standards, making the company’s product a recommended industry solution., • Data-Driven Operations & Risk Management, • Utilize financial models (e.g., LTV, CAC) to optimize business performance., • Build and implement business health metrics, including cash flow alerts and inventory turnover strategies., • Identify and mitigate risks related to channel arbitrage, over-reliance on key clients, and compliance challenges., • Example: Implemented a dynamic pricing system to stabilize gross margins amid raw material price fluctuations., • Change Leadership & Crisis Management, • Navigate industry disruptions, such as regulatory shifts and technological obsolescence, leading successful transformations., • Manage enterprise-level crises, including brand reputation issues and executive departures., • Build team consensus through town halls, incentive realignment, and agile decision-making., • Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Business Administration, or a related field. An MBA or Ph.D. is a plus., • 10+ years of business development experience in the biotech, pharmaceutical, or life sciences industry., • Proven track record in strategic partnerships, licensing, and deal negotiations., • Strong network and relationships within the biotech and life sciences sector., • Excellent communication, negotiation, and leadership skills., • Ability to analyze market trends, competitive landscapes, and financial data to drive business decisions., • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development

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 Program Management Associate will support the planning, coordination, and execution of projects across CMC, GMP manufacturing, and commercial readiness activities in support of Capricor’s therapeutic products. This role is execution-focused and will work closely with cross-functional teams to support GMP-compliant processes, equipment, and program deliverables under the guidance of program and functional management. The Program Management Associate will help ensure alignment across project teams, maintain project tracking and documentation, and contribute to commercial operations including market launch preparation, international market entry support, and long-range planning activities.Responsibilities • Support GMP Facility Commissioning and Readiness: Help coordinate GMP facility commissioning and decommissioning activities, including equipment installation and turnover, tracking and execution of IQ/OQ/PQ, and monitoring alignment with GMP requirements, internal standards, and timelines., • Track Program Schedules and Metrics: Assist in monitoring milestones, deliverables, risks, and key metrics of projects. Escalate issues as needed and support identification of opportunities for process improvement., • Support Document Control and Execution Compliance: Execute and support document control activities, controlled document updates, and adherence to GDP procedures, with good understanding of best practices and CMC principles to ensure documentation accuracy, compliance, and inspection readiness., • Maintain Processes and Documentation: Help develop and maintain standardized tools, templates, and best practices for program and commercial operations. Help ensure program documentation is accurate, current, and well-organized., • Develop Visual Process Maps and Presentations: Assist in drafting process flows, system diagrams, and wireframes using tools such as Microsoft Visio.Required Skills, • Education and Experience: Bachelor’s Degree with 1–3 years of experience in program or project management, GMP facility commissioning and qualification, or a related role within the biotech or pharmaceutical industry, • Collaboration and Initiative: Demonstrated ability to take strong ownership of assigned responsibilities and work effectively within a team; appreciates in-person collaboration and seeks to work at the office from hybrid to full-time, • Problem-Solving and Flexibility: Ability to identify issues, propose solutions, and adapt to changing priorities in a fast-paced environment, • Technical Proficiency: Proficiency in Microsoft Office (Word, PowerPoint, Excel) and familiarity with project management and collaboration tools (e.g., Smartsheet, MS Project, Vizio), • Communication Skills: Strong written and verbal communication skills with the ability to synthesize complex information, facilitate decision-making, and propose key questionsPreferred / Nice to Have Skills, • Experience working in biotech or pharmaceutical program management, commercial operations, or PMO environments., • Hands‑on experience with project tracking tools, dashboards, or resource‑planning systems., • Exposure to commercial readiness, launch planning, or market expansion activities., • Experience supporting cross‑functional team coordination across R&D, regulatory, manufacturing, clinical, commercial, or finance., • Ability to prepare or contribute to presentations, status reports, and program summaries for leadership., • Familiarity with risk management, including identifying risks, tracking mitigation plans, and supporting cross‑functional resolution., • Strong analytical mindset with the ability to interpret data and contribute to strategic discussions.Work Environment / Physical Demands, • Ability to sit and work at a computer for extended periods., • Occasional lifting of materials up to 20 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Scripps Mercy Hospital has served central and downtown San Diego since 1890 and is the oldest medical center in the county. The San Diego campus is located near the corner of 5th Avenue and Washington Street in Hillcrest. Scripps Mercy Hospital consists of two campuses in San Diego and Chula Vista. Scripps Mercy Hospital San Diego’s campus includes the O’Toole Breast Care Center, a 24-hour emergency room that is a Level I Trauma Center, outpatient physical rehabilitation, minimally invasive robotic surgery and our childbirth unit (including a Level II neonatal intensive care unit). This is a benefited, full time position, with day shifts Monday through Friday, to float to our various ambulatory sites across the county. Join the Scripps Health team and work alongside passionate caregivers and provide patient-centered healthcare. Receive endless appreciation while you build a rewarding career with one of the most respected healthcare organizations nationwide. Why join Scripps Health? At Scripps Health, your ambition is empowered and your abilities are appreciated: • Nearly a quarter of our employees have been with Scripps Health for over 10 years., • Scripps is a Great Place to Work Certified company for 2025., • Scripps Health has been consistently ranked as a top employer for women, millennials, diversity, and as an overall workplace by various national publications., • Beckers Healthcare ranked Scripps Health on its 2024 list of 150 top places to work in health care., • We have transitional and professional development programs to create a learning environment that enables you to thrive in your specific field as well as in your overall career. The Clinical Pharmacist Specialist will support our various Ambulatory Services, including Medication Therapy Management, Osteoporosis clinic and Advanced Care Clinic. Understanding that the treatment of diseases extends beyond just medications, we focus on lifestyle and prevention counseling, in addition to the pharmacologic aspects of care. The aim is to get to know what is important to our patients, define a set of goals, and work together to achieve those goals and enhance a person’s overall quality of life. Scripps Ambulatory Clinical Pharmacy Services collaborate with physician specialists to assist with improving the long-term health and quality of life of our patients. This is a unique opportunity and is ideal for someone with ambulatory patient care management experience who is interested in working in various ambulatory care settings. Responsibilities include: • Assumes clinical leadership responsibilities for pharmacy and pharmacy practice in their area of specialization., • Collaborates with physicians and other health professionals to develop intervention strategies to maximize medication utilization related to area of specialization, including but not limited to medication guidelines, clinical pathways, core measures, education and policy development., • Provides collaborative pharmaceutical care with the respective specialized teams in identified patient care areas., • Administers injectable medications, reviews and evaluates ongoing care for appropriateness, safety, and cost; and documents the care provided to patients in the electronic health record (EHR)., • Establishes methods to improve pharmaceutical care, meet identified department and system goals, develop and coordinate utilization reviews and prospective drug use audits and identify and assure collection of pertinent metrics for area of specialization., • Assures regulatory compliance in area of specialization., • Participates in quality assurance efforts for area of specialization., • Actively participates in multidisciplinary committees providing clinical expertise and evidence-based data to assist in guiding value-based practices, developing and deploying standardized treatment regimens protocols and developing and monitoring Quality Assurance / Performance Improvement initiatives. #LI-JS1 Required Education/Experience/Specialized Skills: • BS Pharmacy or Pharm.D. Degree, • California Pharmacist License, • AHA BLS for the health care provider, • Ambulatory patient care management experience

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The HR Coordinator at Capricor Therapeutics will serve as the central point of contact for the employee lifecycle, supporting recruitment coordination, onboarding, record maintenance, and compliance efforts in a fast-growing biotech environment. By ensuring accurate documentation, seamless coordination of HR processes, and responsive support to employees and managers, this role plays a vital part in strengthening people operations, fostering a positive and inclusive workplace culture, and enabling the company’s mission-driven growth as we advance our pipeline toward potential approvals and commercialization.Responsibilities • Serve as the primary point of contact for routine HR inquiries, including holiday calendars, employment verification requests, org charts, policy guidance, benefits navigation, and general HR process support., • Coordinate interview scheduling, candidate communications, reference checks, background checks, and pre-employment requirements in collaboration with recruiters and hiring managers., • Assist with new hire onboarding and orientation activities, ensuring timely and accurate completion of documentation (e.g., I-9, E-Verify, compliance forms, offer letters, and system setups)., • Maintain and audit employee personnel files (digital and physical) to ensure accuracy, confidentiality, completeness, and compliance with company policies and regulations., • Support HRIS updates, payroll-related inputs (e.g., PTO tracking, corrections, bonus spreadsheets), and processing of employee status changes (e.g., promotions, transfers, terminations)., • Prepare HR documents, employee communications, reports, meeting materials, tracking logs, and other administrative support as needed., • Assist with benefits administration tasks, including open enrollment preparation, form tracking, and addressing routine employee benefit questions., • Support performance review and training cycles by tracking deadlines, preparing materials, coordinating sessions, and maintaining related records., • Help maintain compliance with employment regulations, including labor law postings, mandatory training records, EEO data collection/reporting, and policy updates (with emphasis on California-specific requirements)., • Coordinate HR meetings, employee events, culture-building initiatives, and company-wide communications to enhance engagement and morale., • Perform other HR duties and special projects as assigned from time to time.Requirements, • Bachelor’s degree in Human Resources, Business Administration, or a related field preferred., • 1–3 years of HR support experience (e.g., HR Coordinator, HR Assistant, or similar role) in a professional environment; biotech, pharmaceutical, or life sciences industry experience a plus., • Strong organizational skills, meticulous attention to detail, and proven ability to manage multiple priorities and deadlines in a dynamic, fast-paced setting., • Excellent verbal and written communication skills with a customer-service oriented mindset and professionalism in all interactions., • High level of integrity with the ability to maintain strict confidentiality and handle sensitive information with discretion., • Familiarity with HRIS (e.g., ADP, Workday) and ATS systems preferred., • Basic knowledge of employment regulations and best practices; experience with California HR compliance (e.g., wage/hour laws, paid sick leave) a plus., • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) for document preparation, data tracking, and reporting., • Ability to handle occasional extended hours depending on departmental needs (e.g., during peak hiring, open enrollment, or events).Work Environment / Physical Demands, • Primarily office-based with tasks involving HR documentation, system updates, employee interactions, and coordination activities., • Requires prolonged periods of computer use for data entry, document preparation, email communication, and HR system management., • May involve occasional lifting of 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 Therapeutic Specialty Representative San Diego, CA The Role As a Therapeutic Specialty Representative (TSR), youll be on the front lines of a critical product launch, introducing Anaphylm to healthcare providers. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue. As a Therapeutic Specialty Representative (TSR), you will educate healthcare providers on how Anaphylm is designed to address barriers that prevent patients from carrying and administering epinephrine, building trusted relationships to drive adoption of Anaphylm. This role is ideal for ambitious sales professionals who thrive in a launch environment and who want their work to have genuine clinical impact. Key Responsibilities Strategic Territory Development Design and execute territory business plans that identify high-potential accounts and drive measurable market penetration Analyze prescribing patterns, payer landscapes, and competitive dynamics to prioritize efforts and maximize ROI Partner with Regional Sales Managers to align field execution with broader commercial strategy Clinical Education and Relationship Building Deliver compelling, compliant clinical presentations that demonstrate Anaphylm's value in addressing unmet patient need Build trust-based relationships with key prescribers, practice administrators, and healthcare stakeholders through consistent engagement and authentic dialogue Navigate complex clinical objections with insight and empathy, positioning Anaphylm as the solution to real-world challenges Access and Pull-Through Excellence Master payer coverage dynamics across your territory—national, regional, and local insurance landscapes Collaborate with Market Access, to overcome prior authorization barriers and ensure seamless patient onboarding Drive formulary wins and in-office pull-through by equipping providers with the tools and knowledge they need Flawless Execution Orchestrate high-impact customer engagement programs including lunch-and-learns and speaker events Maintain CRM excellence: capture detailed call notes, payer feedback, sampling activity, and strategic next steps with precision Ensure 100% compliance with PDMA sampling requirements, AE/product complaint reporting, and promotional guidelines Field Intelligence Serve as the eyes and ears of the organization, sharing customer insights, competitive intelligence, and best practices that inform strategy Contribute to a culture of continuous learning and improvement across the sales organization Qualifications Required Bachelor's degree 3+ years of pharmaceutical, specialty, or B2B sales success with proven track record of exceeding targets Deep understanding of payer coverage, prior authorization workflows, and access barrier navigation Strong analytical skills with demonstrated ability to translate data into actionable territory strategies Willingness to travel overnight 50% for customer meetings, conferences, and sales meetings Preferred Launch experience in specialty or allergy markets. Specialty pharmacy or hub services background Experience selling products that address medication adherence or administration barriers

Job DescriptionOur client is a top ENR General Contractor immediately looking for a Senior Superintendent to lead $100M+ life science projects in the San Francisco Bay area. The Sr Superintendent supervises the field construction of a single large or complex project or multiple projects, including organization, planning, and scheduling, in order to complete the work on time, within budget, and to quality specified. What You'll Need • Life science, Bio- tech, Lab, Clean room, Pharmaceutical, or medical manufacturing project experience with values over $100M, • Proficient knowledge and use of Primavera P6 scheduling software required., • Proficient in all aspects of building systems., • Thorough knowledge and understanding of the general and subcontract documents, drawings and specifications, construction means, methods and materials, understanding of line and grade and survey methods., • Proficient knowledge of building codes and compliance., • Proficient knowledge of construction cost control and accounting procedures., • Primary liaison with owners/architects/engineers for the day-to-day construction activities of the project., • Participate in project pursuits, proposals and presentations. Main contributor in securing the project during the competition phase., • Lead, supervise and develop Superintendents and other staff, including providing input on or complete performance appraisals., • Develop and implement overall project set-up and site logistics plan and identifying project-specific scope of work to implement the plan., • Develop and implement overall project work schedules identifying the critical path including the expediting of scheduled critical materials and equipment for their timely delivery to site., • Review and respond to subcontractor schedule impacts and or claims of productivity impacts., • Ensure strict adherence to ethics and compliance requirements at all times., • Develop and manage the overall site safety program as required and ensuring subcontractor compliance with company standards and all applicable safety codes and regulations., • Manage and make decisions related to the performance of work related to scheduling, delivery, logistics, quality control and trade employee staffing levels., • Document project field issues that impact budget, quality or schedule., • Respond to subcontractor requests for field issues that impact budget, quality or schedule., • Oversee work among all trades to promote a coordinated project operation. Resolve local area problems, regarding procedures, precedence, design clarifications, adequate labor and equipment, schedule and all other appropriate matters., • Manage labor relations with subcontractors and trade staff.Benefits, • Health, medical, dental, and vison insurance, • HSA/ FSA, • 401 (k) plan, • Paid vacation and holidays, • Project bonuses

Job DescriptionDescription: TruMed Systems, Inc. is the fastest growing vaccine storage and handling company. TruMed serves individual clinics, major health systems, and public healthcare facilities throughout the U.S. TruMed’s mission is to improve health care practitioners’ total outcomes by creating point-of-care inventory management systems that support product efficacy, patient safety, and practice objectives. Our first two products are the AccuVax® Vaccine Management System and AccuShelf ® Inventory Management Systems. Together, our products secure medication and material storage and management that automates control and integrity, minimizes risks of incorrect medication delivery, tracks inventory for all medications and optimizes office workflow in the healthcare settings. Summary The Customer Experience Associate reports into the VP Business Development and Strategic Sales. The CEA will be responsible for the Customer Experience and successful on-boarding across the AccuShelf products for identified Key Accounts. Primary Responsibilities Customer Services: • Building consensus and gaining approval of the telephony provision and all customer contact channels. Makes recommendations that will drive effective customer acceptance and utilization of TruMed Systems products and services, • Identifies and communicates opportunities for product improvement using direct customer feedback, • Participate and manage customer assessments for quality care initiative and assist in developing plan for customer process standardization.Customer Contact:, • Advanced Troubleshooting: Provide support for software and technical issues related to AccuShelf systems, using advanced diagnostic techniques to resolve problems efficiently., • Escalation Handling: Act as the point of escalation for unresolved issues. Analyze cases, develop solutions, and guide customers through the resolution process., • Customer Interaction: Communicate with customers via phone, email, and chat, providing timely updates and ensuring a positive support experience with empathy and professionalism., • System Installations & Upgrades: Support customers with advanced installations, upgrades, and configuration of TruMed’s software and hardware, ensuring compliance with company standards and customer requirements., • Documentation & Reporting: Accurately document troubleshooting steps, resolutions, and interactions in the customer service management system (e.g., Salesforce). Contribute to the creation of knowledge base articles to streamline future issue resolution., • Proactive Problem Identification: Monitor support trends, identify recurring issues, and collaborate with Product to drive improvements in processes and product reliability., • Customer Education: Educate customers on product functionality and best practices to ensure optimal use and reduce support needs., • Team Collaboration: Work closely with internal teams and customers, fostering teamwork and maintaining a professional, timely approach to service delivery.Training and Implementation:, • Participates in or leads pre-sales support, assessment and trial evaluations of new products and services, • Participates in or leads the post-sales assessment, design, implementation and monitoring of new products and services, • Instrumental to creation of product training videos, as needed, along with other peers, • Manages customer Go-Live meetings as it relates to 3rd party interface needs.Customer Engagement, Satisfaction & Insight:, • Driving improvements to the product offering and value proposition, providing direction in how support functions can turn into ‘Insight Engines’;, • Launching and overseeing the Voice of The Customer Program, accountable for its development and optimization of its ‘listening opportunities’; creating a united process for understanding and taking action;, • Influencing a cross-company agreement of how to deliver greatest Customer Experience. Hire, Develop, Train and Motivate top talent, • Recruit, train, supervise, motivate, and evaluate department staff., • Extensive experience in being accountable for Customer Facing Regulatory requirements, overseeing implementation and operation;, • Extensive experience and strong, dynamic leadership in overseeing multiple projects and functions;, • Experience of business development, strategic account planning and identifying growth opportunities;, • Resilient and diplomatic;, • A strategic mind-set, with a well-honed eye for detail, comfortable with data and customer metrics;, • Previous customer success experience in pharmaceutical sales, or medical devices., • Familiarity with the physician office and hospital environment., • Work requires extensive travel (up to 50%) and willingness to work a flexible schedule., • All employees are expected to adhere to the TruMed Systems, Inc, Employee Handbook all times. Specifically, all employees of TruMed Systems, Inc., regardless of role, are expected to:, • Treat others with dignity and respect at all times., • Conduct themselves in an ethical manner at all times., • Support the mission and values of the company. zbH1lhto6L

Job DescriptionAbout Radionetics Radionetics Oncology, a pharmaceutical company focused on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications, is poised to capitalize on the increasing demand for novel radiotherapeutics. The company’s platform technology uses small molecule targeting to deliver therapeutic radioisotopes aimed at novel targets on a broad range of cancers by binding selectively to peptide receptors that are overexpressed on these tumors. This small molecule technology addresses many of the significant challenges currently facing peptide and protein targeted radiotherapeutics. Spun out of Crinetics (Nasdaq: CRNX) in 2021 and financed by 5AM Ventures and Frazier Healthcare, Radionetics is advancing a pipeline of multiple lead drug candidates pursuing first-in-class targets to treat a broad range of cancers. According to commercially available market research reports, the market for radiopharmaceuticals is expected to rise to $12.6 billion by 2027. For more information, visit . Position Summary The Senior Accountant will play a critical role in the day-to-day financial operations of Radionetics. This individual will be a key contributor in the month-end close process, manage the accounts payable function, and assist with the technical execution of clinical trial accruals. The ideal candidate is a Big 4-trained CPA who is ready to transition into a hands-on biotech environment, bringing a high level of technical rigor and "audit-ready" documentation to a growing R&D organization. This role reports to the Senior Manager of Accounting and will work closely with the Controller, CFO, and other cross-functional teams. Essential Job Functions and Duties • General Ledger & Close: Assist with the month-end, quarterly, and year-end close procedures. Prepare journal entries and account reconciliations related to cash, prepaids, fixed assets, and general accruals and assist with the R&D accounting and clinical trial accruals process. Prepare monthly financial statements and flux analyses., • Purchasing: Oversee the end-to-end purchasing workflow to ensure proper coding, internal approvals/compliance with controls, and vendor management. Serve as day-to-day accounting resource for internal stakeholders for all purchasing and contracting inquiries., • AP Oversight: Review and manage all aspects of accounts payable process., • Internal Controls: Maintain and strengthen internal controls over financial reporting and ensure all processes are "IPO-ready.", • Payroll: Process semi-monthly payroll, including collection of relevant support documentation and approvals. Support headcount, payroll, and benefits-related accounting entries/reconciliations., • Audit Support: Serve as a point of contact for external auditors, preparing work papers and providing technical explanations for accounting treatments., • Clinical Trial Accounting: Assist in the month-end clinical accrual process. Collaborate cross-functionally with Clinical Operations and CROs to track patient enrollment, site activities, and milestone payments to ensure accurate expense recognition., • Special Projects: Support the Controller/CFO with ad hoc technical accounting research, tax filings, and preparation of materials for board meetings.Minimum Required Qualifications, • Education: BA/BS in Accounting; CPA license is required., • Experience: 2–4 years of progressive accounting experience. Public accounting experience is required., • Industry Knowledge: Previous experience in the Life Sciences/Biotech sector is preferred, specifically regarding clinical trial accruals and R&D accounting., • Technical Skills: Strong understanding of U.S. GAAP and SOX compliance., • Systems: Proficiency in Excel (advanced formulas, pivot tables), experience with Quickbooks, Prendio, Bill.com, Expensify is preferred., • Communication: Ability to translate complex accounting concepts for non-finance stakeholders (e.g., Project Managers and Scientists). Compensation & Benefits Radionetics has a competitive total compensation package that includes bonus opportunity; equity; medical, dental, vision, life, short-term, and long-term disability insurance; 401(k) retirement plan with employer match; 4 weeks of paid time off (PTO) annually; and generous paid holidays. Pay Range: $95,000 - $120,000 Radionetics evaluates a variety of factors in determining individual pay decisions, which may include relevant education, experience, and skills; internal equity; complexity and responsibility of the role; and market demand relative to the position. Geographic location may also be a consideration in evaluating salary when candidates work in states outside of California. Important notices Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class. The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time. Radionetics does not accept unsolicited referrals from employment agencies for position vacancies unless written authorization is provided from the Human Resources department before any candidates are referred for specific identified positions. In the absence of such written authorization, any actions taken by the employment business/agency shall be deemed to have been performed without consent or contractual agreement, and Radionetics shall not be liable for any fees arising from such actions or referrals for position vacancies at Radionetics. Powered by JazzHR QMAb0KnsGi

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

Job Description DIRECTOR – CLINICAL PHARMACOLOGY JOB TITLE: Director, Clinical Pharmacology LOCATION: San Diego, CA; On-Site; Full Time Redeployment was created to match great people with great Life Science companies! We are seeking an accomplished Director of Clinical Pharmacology to lead clinical pharmacology strategies for a portfolio of small molecule assets. This role will be responsible for guiding dose optimization, assessing pharmacokinetics, and investigating drug interaction potential. The Director will collaborate closely with cross-functional teams, including Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC, to drive effective development strategies. This position requires expertise in study design, data analysis, and regulatory documentation, with a proven ability to represent clinical pharmacology in regulatory submissions. RESPONSIBILITIES: • Develop and implement comprehensive clinical pharmacology and pharmacometrics strategies, including dose selection and optimization, to support the advancement of small molecule candidates from pre-IND to clinical development phases., • Integrate clinical pharmacology insights with a broad understanding of related areas such as clinical development, biostatistics, regulatory affairs, nonclinical studies, and research to inform development decisions., • Design and oversee clinical pharmacology trials, including protocol design, study planning, data interpretation, and results reporting., • Prepare and review sections of clinical protocols, study reports, and other documents specific to clinical pharmacology., • Author regulatory documents (e.g., IND, NDA, IB) and respond to health authority inquiries related to PK/PD and clinical pharmacology data., • Engage with consultants and vendors, ensuring compliance with quality standards, timelines, and study protocols., • Review and interpret clinical pharmacokinetic and pharmacodynamic data provided by external vendors., • Ensure timely execution of PK/PD analyses, including population PK and PK/PD modeling, across studies and programs., • Present clinical pharmacology data and insights to project teams, senior management, investigators, and other stakeholders. QUALIFICATIONS: • Education: Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or a related field., • Experience: Minimum of 7 years of industry or relevant post-doctoral experience in clinical pharmacology., • Regulatory Knowledge: Prior experience with NDA/BLA/MAA filings is preferred, along with experience in authoring and responding to health authority inquiries., • Communication Skills: Demonstrated ability to convey complex pharmacology data effectively to cross-functional teams, senior management, and external stakeholders., • Analytical Skills: Proficiency in interpreting PK, PD, and PK/PD data to inform program decisions and optimize clinical study designs. CULTURAL COMPETENCIES: • Collaborative & Cross-Functional: Thrives in a multi-disciplinary environment, actively working with teams across clinical, regulatory, and research areas., • Data-Driven & Strategic: Applies deep pharmacology insights and data analysis to support strategic decision-making in clinical development., • Attention to Detail: Maintains rigorous standards in protocol design, data analysis, and reporting accuracy., • Effective Communicator: Presents complex data clearly and concisely to internal teams, investigators, and regulatory bodies. BENEFITS: • $165K - $265K; DOE, • Medical Insurance: Comprehensive medical plan options, including HMO and PPO plans., • Dental Insurance: PPO dental plan with coverage for preventive, basic, and major services., • Vision Insurance: Vision plan with benefits for exams, lenses, and frames., • Prescription Drug Coverage: Tiered prescription drug coverage with mail-order options., • Flexible Spending Accounts (FSA): Healthcare and Dependent Care FSAs for eligible expenses., • Life and AD&D Insurance: Basic life and AD&D insurance with additional voluntary options., • Short and Long-Term Disability Insurance: Income protection through short-term and long-term disability coverage., • Employee Assistance Program (EAP): Confidential support and counseling services for employees and dependents.

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 Environmental Health & Safety (EHS) Intern will play an active role in shaping how safety training and compliance are delivered within Arrowhead Pharmaceuticals' fast-paced research and development environment. This internship offers a unique opportunity to help build and modernize a Learning Management System (LMS), collaborate directly with scientists on real-world chemical risk assessments, and gain hands-on exposure to regulatory and laboratory safety programs. The intern will work alongside experienced EHS professionals, contributing to meaningful projects that directly impact employee safety, training efficiency, and regulatory readiness. This is an 11-week Summer Internship Program paying $24.00 per hour and requires full-time, onsite work five days per week at the designated location. Responsibilities • Support the build-out and maintenance of a Learning Management System (LMS), including development of training content and program management., • Work with scientists to develop risk assessments for new chemicals and laboratory activities., • Interface existing EHS programs with the LMS to streamline training and recordkeeping for Hazardous Waste, Bloodborne Pathogens, and Injury and Illness Prevention Plans (IIPP)., • Conduct weekly and monthly inspections of safety equipment throughout the facility., • Assist with new hire onboarding and safety training., • Manage and maintain EHS compliance documentation., • Shadow EHS professionals during compliance audits and inspections., • Present updates and findings in a weekly group setting., • Currently enrolled student at an Accredited University or College and majoring in a scientific discipline, • Excellent verbal and written communication skills, including comfort presenting in group settings., • Strong problem-solving and organizational skills., • Proficiency in Microsoft Office applications., • Ability to lift up to 40 lbs., • Completion of at least two years of coursework towards a degree in Environment, Health, and Safety, Environmental Science, Natural Sciences, or a related field., • Demonstrated interest in learning the EHS function within a pharmaceutical company., • Coursework or experience related to laboratory safety, chemical safety, or regulatory compliance., • Familiarity with training systems, documentation control, or audit processes. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. Essential Duties and Responsibilities: • Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development., • Represent GPV in communication with health and regulatory authorities., • Represent GPV at independent Data Safety Monitoring Committee meetings., • Provide medical oversight of the GPV function including medical review of all cases., • Provide medical input for maintaining REMS, RMP safety monitoring commitments., • In collaboration with other members of GPV, create and maintain a signal detection process for Erasca's products with a clearly defined signal detection strategy for each asset., • In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments., • Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems., • Provide periodic benefit-risk assessment reports for internal use., • Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities., • Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc)., • Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates., • Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis., • Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources., • Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met., • Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors., • Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs., • Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered., • 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred., • Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications., • In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation., • Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred., • Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred., • In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases., • Direct management experience with proven ability to effectively lead, coach, mentor, and manage others., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment., • Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

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 Pharmacovigilance Systems Intern will support Drug Safety operations at Arrowhead Pharmaceuticals by assisting with the configuration, support, and optimization of safety systems. This internship offers hands-on experience working with pharmacovigilance applications while supporting day-to-day safety operations in a regulated pharmaceutical environment. The intern will collaborate with safety and IT stakeholders to troubleshoot issues, analyze new requirements, and ensure systems function accurately and efficiently. This is an 11-week Summer Internship Program paying $24.00 per hour for students pursuing a Bachelors and $26.00 per hour for students pursuing a Masters. This role requires full-time, onsite work five days per week at the designated location. Responsibilities • Support safety systems configuration and maintenance, including updates, enhancements, and bug fixes., • Troubleshoot system issues and assist with issue resolution in collaboration with safety and technical teams., • Analyze new business and regulatory requirements and support configuration and testing activities., • Configure and test new system requirements and updates to existing functionality., • Perform operational tasks within Drug Safety operations, including case management support., • Run listings, queries, and reports from the Elluminate application., • Learn new systems and assist with day-to-day safety system activities., • Currently pursuing or recently completed a Bachelor's or Master's degree in Pharmacovigilance or a related discipline., • Strong verbal and written communication skills., • Excellent problem-solving and analytical skills., • Ability to follow procedures and regulatory requirements., • Excellent verbal and written communication skills, including comfort presenting in group settings., • Strong problem-solving and organizational skills., • Knowledge of Elluminate and/or Argus safety systems., • Prior exposure to pharmacovigilance operations or safety case management., • Experience with system configuration, validation, or user acceptance testing., • Familiarity with regulatory requirements related to drug safety., • Interest in pursuing a career in Drug Safety, Pharmacovigilance Systems, or Regulatory Operations. California pay range $10,560—$11,440 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 Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead's standards for accuracy, clarity, compliance, and scientific integrity. The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs. Responsibilities • Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas., • Perform QC activities (editing and data verification) for clinical and regulatory documents, including but not limited to clinical study protocols and amendments, Investigator's Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books., • Collaborate with lead medical writers and subject matter experts to identify and obtain appropriate QC source materials., • Manage external QC vendors to ensure consistent, high-quality deliverables when additional support is required., • Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead's expanding pipeline., • Support planning and content development for document kick-off meetings, including slide deck preparation as needed., • Bachelor's degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master's or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry., • Exceptional attention to detail, with the ability to identify issues in complex scientific documents, • Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing, • Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments, • Ability to manage multiple priorities while maintaining high-quality standards, • Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint), • Familiarity with basic statistical concepts is a plus 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. 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.

Validation Engineer Location: San Diego, California Long-Term Project Key Responsibilities • Author, review, and execute validation protocols (IQ, OQ, PQ), • Support process, equipment, cleaning, and facility validation activities, • Maintain validation lifecycle documentation and ensure audit readiness, • Support requalification and periodic review activities, • Work with Quality, Engineering, Manufacturing, and external vendors, • Investigate deviations and support CAPA and change control activities, • Ensure compliance with GMP, FDA, and regulatory standards Required Experience • Experience in pharmaceutical, biotech, or medical device industry, • Hands-on validation experience in GMP environment, • Experience with equipment qualification (IQ/OQ/PQ), • Strong protocol writing and execution experience, • Knowledge of validation lifecycle documentation Preferred Experience • Cleaning validation experience, • Facility/utility/cleanroom qualification, • Computer System Validation (CSV/CSA) exposure, • Experience with validation or QMS systems (Kneat, Veeva, TrackWise, etc.)

Role Overview We are seeking a high-caliber Director of Business Development to lead our expansion into the 503A, 503B compounding, medical wellness sectors. You will be responsible for building strategic partnerships with specialized pharmacies to scale our portfolio of patented medical wellness and metabolic health products. Key Responsibilities • Strategic Access: Identify and secure long-term partnerships with 503A/B compounding facilities., • Revenue Growth: Drive sales of our specialized wellness and injectable product lines (including advanced peptides and metabolic therapies)., • Compliance Leadership: Ensure all business activities align with FDA compounding regulations and state board requirements., • Market Intelligence: Stay ahead of trends in the medical wellness and longevity space to identify new product opportunities. Requirements • Experience: 7+ years in pharmaceutical sales or BD, with a proven track record in the compounding pharmacy (503A/B) medical wellness space., • Network: An existing book of business or deep relationships within specialized pharmacy networks., • Knowledge: Strong understanding of the clinical applications of metabolic health and wellness therapies., • Skills: Exceptional negotiation skills and the ability to navigate complex regulatory environments.

Immediate need for a talented Associate Scientific Services Support. This is a 06 months contract opportunity with long-term potential and is located in San Diego, CA(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:26-01622 Pay Range: $20 - $22/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: • Pick up and deliver glassware, biologically contaminated reusable glassware, and plastic ware., • Observe the established procedures for the handling and transporting of glassware and contaminated items., • Undertake specialist cleaning tasks, e.g. autoclaving, ultrasonic cleaning, and potential for pipette processing as part of an agreed periodic routine, • Operate autoclaves for decontamination or sanitization., • Operate glassware washers, dry heat sterilizers, ultrasonic baths, and incubators., • Maintain temperature chart recorders / equipment forms and use proper documentation., • Perform routine inspections/checks on glasswash and autoclave equipment, • Prepare items for sanitization including glassware, caps and related articles, employing procedural steps during the process., • Inspect glassware for cleanliness and structural defects., • Routinely checks inventory of glassware, notifying Lead of deficiencies., • Provide housekeeping of glassware processing areas., • Follow all procedures in performing all aspects of glassware processing., • Perform monthly de-scale and challenging of biological indicators., • Use Good Documentation Practices (GDP) for all paperwork., • Observe all safety precautions and is proactive in raising safety concerns., • Complete all required trainings in a timely manner., • This role will work closely with other teams to seamlessly deliver lab support services., • Will be required to cross-train and back-up other lab support areas as needed., • Expected Hours:40 , 8am-5pm (Flexible could be 7am-3:30pm) Key Requirements and Technology Experience: • Must have skills: - Instrumentation cleaning, glassware washers, sterilization, • High School Diploma or GED., • Ability to follow oral and written directions., • Demonstrates appropriate use of relevant equipment after training., • Previous glass wash experience preferred., • Ability to sit or stand 2-3 hours in laboratory areas., • Walk 2-3 hours within a facility and walk outside to multiple buildings on campus., • Reach above/below the shoulder, bend at the knees and waist., • Lift up to 25 lbs., • Office work activities, including keyboard, with fingers/hands/arms up to 4 hours., • Work around moving laboratory equipment and machinery., • Use of personal protective equipment in laboratory., • Work with biohazards such as blood borne pathogens., • Must be able to work in a laboratory, controlled environments requiring personal protective equipment., • Job pace may be fast and job completion demands may be high., • Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations., • Duties may include: Identifying, handling, generating, accumulating, storing, labeling., • Ensure safety, security, and the environment in all aspect of the daily activities, and any potential safety hazards are addressed and corrected immediately., • Understand ergonomic relationship between people, equipment and working environment. 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, 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. 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 ___.

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 30 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 30 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Graphics and Web Designer / Developer to integrate digital strategy, visual design, UX, and motion graphics expertise to elevate brand awareness across digital and print media to strengthen customer engagement and drive customer acquisition. S/he will own Invivoscribe’s presence across web, email, social media, and multimedia formats, while ensuring that all design output aligns with scientific accuracy, branding standards, and optimized user experiences. Core Responsibilities Include: Website Management • Optimize website for performance for organic visibility, (e.g. LLM SEO, GEO, AEO) and accessibility. Troubleshoot and resolve design or functionality issues., • Front-end development includes content management, performance, security, and UX updates in collaboration with product marketing team., • Apply and maintain UX best practices to enhance navigation, optimize content structure, and support customer journeys., • Create high quality visual assets including graphics, illustrations, motion design, and animations for campaigns, educational content, product support, and social media., • Maintain and expand Invivoscribe’s digital asset libraries, visual identity systems and iconography., • Produce multimedia content that supports product launches, educational initiatives, and thought leadership., • Own and maintain brand guide to ensure visual consistency across all channels., • Contribute to copy, visual direction, and strategic content planning for major campaigns., • Bachelor’s degree in marketing, design, communications, or a related creative discipline and 5+ years of experience in digital marketing, visual design, web design, and/or multimedia design; life science experience highly preferred., • Sound proficiency in SEO, SEM, Google Analytics, and marketing automation platforms., • Sound proficiency in managing and modifying WordPress sites, including theme customization, plugin integration, performance optimization, and security best practices., • Expertise with motion design, animation, 3D design, and visual design, including Adobe Creative Cloud mastery (After Effects, Illustrator, Photoshop, InDesign, Premiere and/or Animate)., • Skilled in front end web development, including HTML, CSS, JavaScript, responsive design standards, and cross browser optimization., • Able to perform basic-intermediate level back-end web development., • Skilled in UX principles to improve navigation, workflow, and user interactions, ensuring intuitive access to scientific and technical content., • Skilled in creating wireframes, prototypes, and interface layouts using tools such as Figma or Sketch, with attention to clarity, hierarchy, and accessibility., • Familiarity with analytics tools to evaluate and improve user behavior, conversion pathways, and digital experience effectiveness., • Demonstrated understanding of web accessibility guidelines and compliance requirements to support global scientific and clinical audiences., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.

LTC Closed Door Pharmacist Highlights • Contract assignment, • Onsite role (Closed-door LTC pharmacy), • Schedule: Monday–Friday, 2:30 PM – 11:00 PM, • Weekends may be required based on business needs, • Location: San Diego, CA LTC Closed Door Pharmacist Responsibilities • Accurately accept, verify, and dispense prescription medications, • Ensure medications are dispensed in compliance with state and federal regulations, • Monitor patient medication usage and identify potential compliance issues, • Maintain accurate and confidential patient medication records, • Provide medication consultation and clinical guidance as needed, • Compound medications for internal and external use, including sterile preparations, • Supervise pharmacy technicians and support staff, • Maintain appropriate pharmaceutical inventory levels, • Identify and resolve drug-related problems in collaboration with prescribers, • Work closely with physicians, nurses, pharmacists, and pharmacy interns

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Summer Fridays, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description The Clinical Account Manager (CAM) acts as the primary customer contact for sales demand creation by executing marketing strategy and promoting Sobi products as lead by the Regional Sales Director. In this strategic role, the CAM provides current and comprehensive clinical knowledge of Sobi’s products and effectively communicates the on-label clinical benefits of the products. As a sales leader, the CAM is expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages to customers, representing Sobi at local meetings, and achieving or exceeding sales targets. *Please note this is a remote position but candidate must reside within the territory (San Diego) • Responsible for representing Sobi’s products and services to a defined customer base, generating and growing sales and consistently achieving or exceeding sales goals within a specific geographic area and actively promotes the appropriate use of Sobi products to healthcare professionals in accordance with all Corporate, PhRMA, and OIG guidelines, • Comprehensive understand of Sobi and competitor products in their therapeutic area, and an in-depth knowledge of the disease states., • Develops and implements a territory business plan to meet customer needs and achieve sales goals and weekly analysis of territory sales data to help prioritize physician targeting and ensure accurate reporting of physicians, • Strict compliance with all regulatory agencies, state, and federal law is required., • Prepares territory budget plans for customer contacts, local symposia, and other miscellaneous external expenditures, • Assists in the identification and resolution of issues and opportunities and communicates proactively to sales and marketing management., • Reports all adverse events to Sobi’s Drug Safety department as appropriate per required guidelines, • Performs all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc.Qualifications, • Located within the territory, • BA/BS in business or science, • Minimum of 5 years’ with dedicated hospital selling experience in the Pharmaceutical or Biotechnology industry, with minimum of 3 years’ specialty sales experience in the Pharmaceutical or Biotechnology industry, • A CAM will have a minimum of 3 years’ of biologics sales experience that will utilize a specialty pharmacy or 8 years with dedicated hospital selling experience. Experience with a transition of care/patient journey process from the hospital to the outpatient setting, • Demonstrated history of high sales performance, • Experience with single source pharmacies, reimbursement programs, managed care, and formulary, • Strong work ethic, ability to develop priorities, and manage time appropriately in a large, assigned geography., • Travel within the assigned territory, including overnights, which could be as high as 40-50% in some cases. Must be based in, or located near given geographic territory (relocation will not be provided), • This individual will also be responsible for accurately performing all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc., and travel within the assigned territory, including overnights, which could be as high as 40-50% in some cases. Must be based in or located in close proximity to given geographic territory (relocation will not be provided). Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to Know Your Rights

A pioneering pharmaceutical company is seeking a Senior Director of Pharmacovigilance Operations to oversee safety data management and vendor compliance. Key responsibilities include integrating safety data systems, managing budgets, and ensuring compliance with regulatory standards.

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 Information Systems & Informatics Quality Systems Manager is responsible for the ownership, oversight, and continuous improvement of enterprise Quality Systems and associated systems that support regulated business processes. This role ensures that Quality Systems are compliant, validated, and effectively support the business. The position serves as key liaison between IS&I and Quality, with a strong focus on Business process & configured system effectivity, continuous improvement, regulatory compliance, system lifecycle management, and audit readiness. Responsibilities • System Owner - manage electronic QMS and processes, including Change Control, Deviations, CAPAs, SCARs, Audits, Findings, Suppliers, Complaints Management, Batch Release Management, Document Management, Training, etc., • Ensure systems align with established Quality System procedures and business process requirements., • Identify and lead continuous improvement initiatives to enhance system usability, compliance, and efficiency., • CSA.CSV expertise, • Regulatory Applicability Assessments/Risk assessments, • IQ/OQ/PQ documentation, • Periodic review, • Create and manage system changes through formal change control processes., • Ensure proper system configuration, access control, data integrity, and backup/recovery practices., • Cross-Functional Collaboration, • Partner with business partners to ensure systems effectively support business needs., • Act as a subject matter expert (SME) for Quality systems & Processes across the organization. Requirements • Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, or related field., • 7+ years of experience implementing/supporting GxP-regulated IT systems within pharmaceutical, biotech or equivalent Commercial Operations background., • Strong knowledge of Quality Systems and QMS business processes., • Hands-on experience with system validation and compliance in regulated environments., • In-depth understanding of 21 CFR Part 11, EudraLex Annex 11, and data integrity principles., • Experience supporting audits and regulatory inspections., • GxP compliance and regulatory knowledge, • CSA/CSV expertise, • Quality mindset with strong attention to detail, • Excellent communication and stakeholder management skills, • Ability to balance compliance requirements with business efficiency, • Leadership in cross-functional, matrixed environments Preferred: • Direct Veeva Vault Quality administration experience., • Experience supporting automation, engineering, commercial manufacturing, quality operations. Wisconsin pay range $120,000—$150,000 USDCalifornia pay range $130,000—$165,000 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 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.

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.