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Job DescriptionDescription: About the Company As a life science company and a leading supplier to global research markets, we offer a comprehensive product portfolio along with outstanding hands-on customer service to ensure every laboratory has the tools and support they need. Our markets include pharmaceutical and biotechnology businesses, research institutions, hospitals, reference labs, and more. Be part of making a difference At Genesee, we believe we can help improve our communities and transform the world through science. Our shared desire to make a difference is what drives and inspires us. We are a fast-growing, dynamic team that listens to each other and embraces collaboration. We foster an open, friendly work environment and show up for one another every day. Role: Sr. Sales Development Representative (SDR) Reports to: Regional Director of Sales FLSA: Non-Exempt Location: El Cajon, CA Why is this role important at Genesee Scientific? The Sr. Sales Development Representative (SDR) plays a critical role in developing and expanding relationships with existing customers and re-engaging inactive accounts. This role focuses on account growth, retention, and long-term customer success, working closely with Account Managers and Sales Leadership to drive sustained revenue. What will you do: • Own and manage an assigned book of existing and inactive customer accounts, • Proactively engage customers to understand purchasing behavior, challenges, and future needs, • Re-engage dormant accounts and identify opportunities to restore and grow spend, • Educate customers on Genesee’s products, services, promotions, and value proposition, • Drive incremental revenue by engaging in discovery conversations and gaining customer commitment to participate in a future meeting with their Account Manager, • Use Salesforce and sales tools to track customer interactions, pipeline, and opportunities, • Collaborate with Customer Service and Marketing to deliver a seamless customer experience, • Bachelor’s degree in business, science, or equivalent experience, • 1–3 years of experience in sales, account support, customer development, or customer-facing roles, • Strong communication skills with the ability to build and maintain customer relationships, • Proven ability to manage multiple accounts and priorities, • Results orientated, strong work ethic and an ability to excel within a rapidly changing and growing organization, • Proficient in Microsoft Office Suite applications; experience with CRM/Salesforce is a plus, • Enjoy owning relationships and driving account growth, • Are proactive, organized, and comfortable managing a book of business, • Can navigate customer conversations and objections, • Are curious, analytical, and solution-oriented, • Are comfortable using technology and data to guide decisions Perform the following tasks, with or without reasonable accommodation: • Primarily sedentary work on a computer in a climate-controlled office environment, • Regularly sit for extended periods, with occasional standing, walking, and lifting of up to 25 pounds, • Training and professional growth initiatives, including comprehensive onboarding programs for new team members, • We provide financial well-being with competitive compensation packages and 401 (k) retirement savings plans, • Health care and well-being programs including medical, dental, vision, life, short- and long-term disability and employee assistance programs Employment offers are subject to successful completion of a background check and pre-employment drug test. Genesee Scientific is proud to be an Equal Employment Opportunity employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. Requirements:

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The 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.

Bachelor’s degree in Accounting or Finance required; CPA certification preferred. Progressive experience spanning public accounting and industry roles within life sciences environments such as biotechnology, pharmaceuticals, or medical devices; large public accounting firm experience strongly pref

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.

Executive Director, Clinical Development (MD) On-site in San Diego Must have an MD Overview The organization is seeking a senior physician leader with extensive experience in obesity and cardiometabolic drug development to establish and lead clinical strategy across its therapeutic pipeline. This role will provide medical and strategic direction for programs spanning early clinical research through late-stage development, with particular focus on obesity and related metabolic disorders. The Executive Director will guide the advancement of novel therapeutics by integrating clinical science, regulatory strategy, and operational execution. The successful candidate will have a proven record of leading complex clinical programs, influencing cross-functional teams, and delivering high-quality clinical data in a biotechnology or pharmaceutical environment. Key Responsibilities Clinical Strategy & Portfolio Leadership • Define and oversee clinical development strategy for obesity and metabolic disease programs across all phases of development., • Provide senior medical leadership for study design, conduct, and interpretation, including endpoints, patient populations, safety oversight, and benefit–risk evaluation., • Serve as the company’s internal medical authority for metabolic disease programs and advise executive leadership, project teams, and external partners., • Provide accountability for execution and quality of assigned clinical programs., • Oversee development of clinical protocols, amendments, and integrated development plans., • Ensure study deliverables are completed within timelines, budget, and quality expectations., • Serve as the senior medical representative in interactions with regulatory agencies for assigned programs., • Partner with Regulatory Affairs, Clinical Operations, Biostatistics, CMC, and Program Management to align development and submission strategies., • Lead medical contributions to key regulatory documents including INDs, investigator brochures, clinical study reports, and regulatory briefing materials., • Participate in regulatory meetings and health authority interactions (e.g., FDA, EMA)., • Lead collaboration across clinical operations, pharmacovigilance, translational sciences, biostatistics, and commercial teams., • Build relationships with key opinion leaders, investigators, and advisors in obesity and metabolic disease., • Medical degree (MD) required, • 10+ years of clinical development experience within the pharmaceutical or biotechnology industry, • Demonstrated experience leading clinical studies in obesity or metabolic disease, • Significant leadership experience, including oversight of teams or programs, • Track record of directing clinical programs across multiple development stages, • Strong understanding of drug development strategy, clinical operations, and planning, • Expertise in clinical data analysis and interpretation, • Familiarity with SOPs, GCP, ICH guidelines, and regulatory compliance, • Experience supporting regulatory submissions and agency interactions (IND, NDA/BLA), • Board certification in Endocrinology, Diabetes, Metabolism, or related specialty, • Experience within a clinical research or biotech operational environment, • Strategic thinking and program prioritization, • Strong cross-functional collaboration and leadership, • Effective decision-making and problem solving, • Organizational and communication skills, • Full-time position, • Competitive compensation based on experience, • Equity participation and performance bonus eligibility, • Retirement plan with employer match, • Medical, dental, and vision coverage, • Flexible spending programs, • Life insurance and employee assistance programs, • Paid time off and holidays

Senior Drug Safety Associate Location: Bay Area, California (On-site, 5 days per week) Company: Excelexis About the Company Excelexis is an innovative biotechnology company focused on advancing novel therapeutics to address serious and unmet medical needs. The team combines strong scientific expertise with a collaborative, fast-paced culture dedicated to bringing impactful treatments to patients. As the company continues to expand its clinical pipeline, they are looking to add a Senior Drug Safety Associate to support and strengthen their pharmacovigilance function. This is an on-site position in the Bay Area (5 days per week). Relocation support is available, and the role comes with a very competitive compensation and benefits package. Position Overview The Senior Drug Safety Associate will support global pharmacovigilance activities, ensuring the accurate collection, evaluation, and reporting of safety data from clinical trials and post-marketing sources. This individual will play a key role in maintaining compliance with global regulatory requirements while collaborating closely with Clinical, Regulatory Affairs, and external vendors. Key Responsibilities • Process and manage Individual Case Safety Reports (ICSRs) from clinical trials, literature, and spontaneous sources., • Perform case intake, triage, data entry, coding (MedDRA/WHO-Drug), and quality review within the safety database., • Ensure timely submission of safety reports to regulatory authorities in accordance with global reporting timelines (e.g., FDA, EMA)., • Assist with preparation and review of aggregate safety reports including DSURs, PSURs/PBRERs, and line listings., • Support signal detection and safety data review activities as required., • Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Medical Affairs to ensure complete and accurate safety information., • Work with external pharmacovigilance vendors and CROs, ensuring quality and compliance with internal processes., • Contribute to the development and maintenance of SOPs, work instructions, and pharmacovigilance processes., • Participate in internal audits and regulatory inspections as needed. Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field., • 3–6+ years of pharmacovigilance / drug safety experience, preferably within biotech or pharmaceutical companies., • Strong knowledge of global pharmacovigilance regulations and reporting requirements (FDA, ICH, EMA)., • Experience with safety databases (e.g., Argus, ArisG, or similar systems)., • Familiarity with MedDRA coding and safety case processing., • Excellent attention to detail and ability to manage multiple priorities in a fast-paced environment., • Strong communication and collaboration skills. Why Join • Opportunity to join a growing biotech with an exciting clinical pipeline., • Highly competitive compensation package including salary, bonus, and equity., • Relocation assistance available for candidates outside the Bay Area., • Collaborative and mission-driven team environment.

Company Description Candid Therapeutics is a clinical-stage biotechnology company that is committed to advancing innovative treatments for a variety of immunological conditions. As a forward-thinking leader in the biotech space, we focus on developing groundbreaking therapies to address unmet medical needs. Our mission is to improve patients' lives through cutting-edge biomedical research and collaboration. Candid Therapeutics values innovation, teamwork, and a patient-centered approach in all aspects of our work. Role Description This is a full-time remote role for a Senior Medical Director (or Executive Medical Director). In this role, you will provide clinical and strategic leadership for our therapeutic programs, actively contributing to the design and implementation of clinical trials. You will oversee relationships and communication with internal teams and external collaborators, including physicians. Additional responsibilities include contributing to medical and scientific materials, providing expertise in therapeutic areas, and guiding regulatory and compliance activities to support product development. Qualifications • Advanced medical expertise in areas such as Rheumatology, Immunology, Neurology, or Pulmonology, • Established network and proven experience working collaboratively with physicians and healthcare professionals, • Minimum 3 year experience and strong understanding of clinical trial design/execution processes in the biotechnology or pharmaceutical industry, • Exceptional communication, leadership, and organizational skills and able to effectively work closely with other functions, • Strong ability to think outside the box and execute independently, efficiently, and creatively, • MD, DO, or equivalent clinical degree with relevant board certification preferred

Job Details Dir/Sr. Medical Director, Clinical Development Job Code #: 26CLDEV-2 Status: Exempt, Full Time Reports to: VP, Clinical Development Department: Clinical Development Location: San Diego Headquarters, Hybrid Contact: About Us! Actio Biosciences, Inc., is a drug discovery and development company grounded in the science of precision medicine. Actio is developing a portfolio of drugs to modulate the activity of proteins responsible for rare diseases with the goal to also translate these findings into treatments for common diseases with shared underlying disorders. Actio has built an integrated discovery engine with deep human genetics, bioinformatics, and drug discovery expertise. Actio was founded in October 2021, and is funded by Canaan, Deerfield Management, Droia, EcoR1 and Euclidian Capital. Come join an exciting and rapidly growing team dedicated to discovering transformational therapies for patients with severe unmet medical needs. At Actio, our employees are passionate about their work and believe in the power of teamwork, collaboration, and mutual respect. Visit: About You! Reporting directly to the Vice President, Clinical Development, the Medical Director / Senior Medical Director, Clinical Development, will play a critical leadership role in advancing the clinical development strategy for one or more pipeline programs. In this highly visible role, you will serve as the Program Team Lead (PTL) for a clinical asset, providing medical and scientific leadership across multiple indications. You will be responsible for both the strategic design and operational execution of clinical development plans, while also fulfilling medical monitoring responsibilities. The ideal candidate brings prior experience from small to mid-sized biotechnology companies and deep expertise in rare diseases and/or neurology. You will partner closely with cross-functional development teams, senior leadership, investigators, and external partners to ensure rigorous, efficient, and patient-focused clinical development. This position offers a unique opportunity to contribute strategically and operationally in a dynamic biotech environment, helping shape innovative therapies for patients with high unmet medical needs. You will be responsible for: • Leading a cross-functional, matrixed development team across research and development as Program Team Lead, in close partnership with the program manager., • Developing, maintaining and executing the clinical development plan across multiple indications., • Designing clinical trials and authoring or reviewing key study and regulatory documents, including protocols, Investigator Brochures, IND submissions, Clinical Study Reports, and related materials., • Providing ongoing medical monitoring for clinical studies, including oversight of patient safety and signal direction., • Analyzing, interpreting, and presenting clinical data and study results to internal stakeholders and external audiences., • Monitoring and interpreting the competitive landscape to inform program strategy., • Supporting the identification and selection of clinical investigators and maintaining strong professional relationships as the Sponsor medical representative., • Identifying resource needs and supporting budget planning and personnel forecasting for clinical programs., • Proactively identifying program risks and partnering with the program manager to develop mitigation strategies., • Participating in the preparation of abstracts, manuscripts, and scientific presentations for external meetings., • Providing clear, timely program updates and communicating effectively with senior leadership., • Contributing to a collaborative, respectful, and patient-focused work environment., • Performing other duties as assigned. You have the following skills and qualifications: Education & Experience • MD required; active medical license preferred but not required., • Formal training in Neurology (residency and/or fellowship) with hands-on patient treatment experience., • Minimum of 5 years of drug development experience within a biotechnology or pharmaceutical company., • Demonstrated leadership experience on development project teams (e.g., core team member, sub-team leader)., • Prior experience serving as a medical monitor for clinical trials., • Experience in rare disease, neurology, and/or genetic disorders strongly preferred., • Experience addressing pediatric patient needs preferred., • Experience interacting with global regulatory agencies (FDA, EMA, or other health authorities) preferred. Knowledge & Skills • Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements for investigational drug development., • Familiarity with FDA and/or EMA regulations, ICH guidelines, and global clinical development standards., • Ability to navigate complex scientific and business challenges in a cross-functional, matrixed environment., • Strong decision-making, problem-solving, organizational, and analytical skills., • Excellent written and verbal communication skills, with the ability to clearly convey plans, risks, and results to diverse stakeholders., • Deep understanding of translation medicine, biomarker development, clinical study design, and execution, biostatistics, data analysis, and scientific reporting., • Comfort working in a fast-paced, small company environment with evolving priorities and minimal direction. Why Actio? The work culture at Actio fully embraces teamwork, collaboration and mutual respect. We believe that our employees are our greatest asset, and we strive to create an inclusive and empowering environment where everyone feels valued and respected for who they are. We encourage our employees to bring their unique perspectives and experiences to the table and we believe that this diversity is what makes us stronger as a team. We invest in supporting our employees to succeed both at work and at home, and we believe that a good work-life balance is essential for everyone’s well-being. If you thrive in an environment where you are inspired by others and empowered to participate to your fullest potential alongside exceptionally talented and kind human beings - - -Actio is the place for you! We are committed to ensuring all employees, both current and future, receive fair and equitable pay. Base pay is one component of the total compensation package, and is determined within a range according to role, level, and location. This provides the opportunity for growth as you gain experience and develop within a role, while also allowing for differentiation based on performance. The base pay range for this role is between $260,000 to $350,000 and reflects our good faith estimate of the minimum and maximum target for the position as of the date of posting and may be modified in the future. The final base pay within the range will be determined by work location and additional factors, including job-related skills, experience, relevant education or training, and market demand for your expertise. Benefits programs offered include: • Medical, dental and vision insurance (employee premiums covered by Actio at 90%), • Health Savings Account with a rich employer contribution, • Flexible Savings Account for healthcare and dependent care, • Mental health and wellness benefits, • 401k plan participation, • Equity Incentive Plan participation (stock options), • Life/AD&D/ST and LT Disability Insurance (premiums covered by Actio at 100%), • Supplemental benefits including legal service, pet insurance and other optional coverage, • Weeklong winter holiday shutdown & generous paid time off and holiday policies, • And more! Details of participation in these benefit plans will be provided with an employment offer. Actio benefits and compensation programs are subject to eligibility requirements and other terms of the applicable plan or program. Actio is committed to building a diverse workforce and providing equal employment opportunities to all employees and applicants for employment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. The above is intended to describe the general content of, and requirements to perform this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. To apply, please send your CV/resume and cover letter by email to: , and reference Job Code #: 26CLDEV-2 in the subject field.

Safety Systems Manager Location: Bay Area, California (On-site, 5 days per week) Company: Excelexis About the Company Excelexis is an innovative biotechnology company dedicated to developing transformative therapies for patients with serious and unmet medical needs. With a strong scientific foundation and a growing clinical pipeline, the company fosters a collaborative and fast-paced environment focused on advancing impactful medicines. As the organization continues to scale its pharmacovigilance infrastructure, they are seeking a Safety Systems Manager to lead the management and optimization of their drug safety systems. This is an on-site role based in the Bay Area (5 days per week). Relocation support is available, and the position offers a very competitive compensation and benefits package. Position Overview The Safety Systems Manager will be responsible for the administration, configuration, and continuous improvement of pharmacovigilance systems supporting global safety operations. This individual will work closely with Pharmacovigilance, Clinical, Regulatory, Quality, and IT teams to ensure safety systems remain compliant, efficient, and scalable as the company grows. The role will also oversee system validation, vendor management, and data governance related to safety platforms. Key Responsibilities • Serve as the system owner and administrator for the pharmacovigilance safety database (e.g., Argus, ArisG, or similar platforms)., • Manage system configuration, upgrades, patches, and enhancements to support global safety operations., • Ensure compliance with regulatory requirements related to pharmacovigilance systems (FDA, EMA, ICH guidelines)., • Lead computer system validation (CSV) activities for safety systems, including documentation, testing, and change control., • Collaborate with Pharmacovigilance teams to optimize workflows for case processing, reporting, and signal management., • Oversee data integrity, system security, and user access management., • Manage relationships with external vendors and system providers., • Support aggregate reporting and regulatory submission workflows through system optimization., • Develop and maintain SOPs, system documentation, and training materials., • Provide training and user support to internal stakeholders on safety system functionality., • Support regulatory inspections and internal audits related to pharmacovigilance systems. Qualifications • Bachelor’s degree in Life Sciences, Computer Science, Information Systems, or a related field., • 5+ years of experience in pharmacovigilance systems or safety operations, preferably within biotech or pharmaceutical companies., • Hands-on experience with drug safety databases such as Argus Safety, ArisG, or similar PV platforms., • Strong understanding of pharmacovigilance regulations and compliance requirements., • Experience with computer system validation (CSV) and system lifecycle management in a regulated environment., • Familiarity with MedDRA, E2B reporting standards, and safety data workflows., • Strong analytical and problem-solving skills with the ability to improve operational efficiency., • Excellent cross-functional communication and project management skills. Why Join • Opportunity to play a key role in building and scaling pharmacovigilance systems at a growing biotech., • Highly competitive compensation package, including salary, bonus, and equity., • Relocation assistance available for candidates moving to the Bay Area., • Collaborative and mission-driven team environment focused on improving patient outcomes.

About the Company Cellics Therapeutics is a rapidly growing biotech company developing novel therapeutics for inflammatory and infectious diseases based on the award-winning Cellular Nanoparticle technology. Cellics offers a highly motivational and rewarding work environment with attractive salary and benefits. About the Role Cellics Therapeutics is seeking a Director/Sr. Director of Downstream Process Development and Manufacturing to provide strategic, technical, and scientific leadership in process development and GMP Manufacturing for non-clinical, clinical, and commercial nano-therapeutics and vaccines. Responsibilities • Lead the design and execution of phase-appropriate process development, technology transfer, process characterization and validation associated with the implementation of cGMP-compliant manufacturing processes and systems for novel nano-therapeutics and vaccines from the development stage to commercialization., • Identify and control critical process parameters (CPPs) and critical quality attributes (CQAs) across cell handling, nanoparticle synthesis, coating, purification, and fill/finish., • Design robust, reproducible processes that minimize operator dependence and variability., • Support deviation investigations, root cause analyses, and CAPAs related to process issues., • Own CMC strategy for IND and subsequent regulatory submissions., • Ensure processes, controls, and documentation are suitable for FDA review., • Define manufacturing requirements, batch records, and process controls., • Partner with Regulatory Affairs and author relevant regulatory submission documents (pre-IND, IND, BLA, etc.) and provide strategic guidance on regulatory interactions relating to process development and validation., • Translate non-clinical and clinical study demands of new candidate biological therapeutics to development timelines and manufacturing strategy for IND and BLA., • Drive continuous improvement through technological innovation to support ongoing product development effort., • Draft, review, and approve process development reports and technology transfer protocols/reports for both internal and external cGMP manufacturing facilities., • Evaluate, select, and manage CDMO partners., • Provide technical support to internal and external cGMP operations. Qualifications • Doctoral (Ph.D.) degree in relevant Science/Engineering/Biotechnology with demonstrated leadership experience and subject matter expertise in biologics process development and GMP manufacturing., • At least 10 years of experience in a biotech or pharmaceutical organization., • Hands-on experience with nanoparticle fabrication processes, purification processes, and microfluidization processes highly desired., • Deep and broad knowledge of relevant cGMPs, ICH guidelines, and QBD principles., • Experience with process development of biologics therapy in various stages of development (preclinical to commercialization)., • Experience in technology transfer including transitioning of research process into cGMP process and transferring existing or new process to internal and external manufacturing facilities., • Experience in preparing and updating regulatory filings (IND, BLA)., • Demonstrated experience in building and leading exceptional teams., • Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision., • Ability to manage multiple projects, prioritize objectives, and manage resources to achieve established deadlines. **Please, no search firms.

Closing Date: Open Until Filled Yes Classification Title BIOTECHNOLOGY: Adjunct / Substitute Instructor POOL (college credit) Working Title Adjunct Faculty Recruitment Limits Location District Wide Pay Information You may view the current salary schedule by clicking. FLSA Status Non-Exempt (accrues

Job DescriptionDescription: About the Company As a life science company and a leading supplier to global research markets, we offer a comprehensive product portfolio along with outstanding hands-on customer service to ensure every laboratory has the tools and support they need. Our markets include pharmaceutical and biotechnology businesses, research institutions, hospitals, reference labs, and more. Be part of making a difference At Genesee, we believe we can help improve our communities and transform the world through science. Our shared desire to make a difference is what drives and inspires us. We are a fast-growing, dynamic team that listens to each other and embraces collaboration. We foster an open, friendly work environment and show up for one another every day. Role: Data Entry Specialist - Customer Service Reports to: Customer Service Manager FLSA: Non-Exempt Location: El Cajon, CA Why this role is important at Genesee Scientific? The Data Entry Specialist is an important member of the Customer Service team. This role ensures high-volume customer orders and related system updates are entered accurately and efficiently, supporting consistent and reliable customer experience. With a primary focus on transactional accuracy and data integrity, the Data Entry Specialist helps maintain clean, dependable system records that support smooth order processing. This role also provides backup support to the Customer Service team as needed. What You Will Do: Primary Responsibilities: • Enter and manage customer orders accurately in ERP and CRM systems, • Process orders from multiple portals with strong attention to detail, • Review orders for completeness, correct pricing, shipping instructions, and special requirements, • Maintain accurate customer and system data, • Monitor order queues to ensure timely processing, • Identify and escalate discrepancies to prevent fulfillment issues, • Provide cross-functional support to Customer Service team members during peak periods to ensure a seamless customer experience, • Respond to routine customer inquiries via email or phone with professionalism and urgency, • Partner closely with Sales, Operations, and Finance to clarify order details, resolve data discrepancies, and support on-time, accurate fulfillment, • High School diploma or GED required; associate or bachelor’s degree preferred or equivalent work experience, • 1+ years of experience in data entry, order processing, or administrative support roles, • Demonstrated accuracy and attention to detail in high-volume environments, • Experience working in ERP and/or CRM systems (Sage100, Salesforce a plus), • Ability to navigate multiple systems and monitors, • Desire to work as part of a team, but also able to work independently, pay attention to details and solve problems quickly, • Basic proficiency in Microsoft Office Suite applications, including Teams preferred Perform the following tasks, with or without reasonable accommodation: • Primarily sedentary work on a computer in a climate-controlled office environment, • Regularly sit for extended periods, with occasional standing, walking, and lifting of up to 10 pounds, • Training and professional growth initiatives, including comprehensive onboarding programs for new team members, • We provide financial well-being with competitive compensation packages and 401 (k) retirement savings plans, • Health care and well-being programs including medical, dental, vision, life, short- and long-term disability and employee assistance programs, • Paid time off including vacation, sick and 12 holidays Candidates must be legally authorized to work in the United States without the need for current or future employer sponsorship. Employment offers are subject to successful completion of a background check and pre-employment drug test. Genesee Scientific is proud to be an Equal Employment Opportunity employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

Job Title: Chemistry MFG Technician I Location: San Diego, CA Pay: 22.85/hr Description: The GMP Biotechnician will work closely with several departments such as QA and inventory control to understand and streamline manufacturing production processes. This position will be responsible for filling, capping, labeling, completing detailed batch records, putting away finished good inventory (FGI), data entry, equipment maintenance, supply inspections & storage. This role will require verification and sign off on records as well as label creation and inspections. Data entry responsibilities include scanning and attaching records into our system, CoA creation and processing work orders through our Enterprise Resource Planning (ERP) system. BioLegends regulated product produced in our US FDA registered Good Manufacturing Practices (cGMP) manufacturing facility. The duties include vialing of the product according to standard operating procedures. Another part of the job responsibility includes preparing product/project related documentation and maintaining the device history records for all the regulated products. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Perform vialing, and labeling of regulated products. Maintain batch records and other documentations that are essential to be in compliance with ISO13485:2016 and MDSAP regulations. Maintain laboratory equipment and manage laboratory supplies. Receiving materials (inspection, organizing/labeling, & updating logs). Printing labels for final product production. General buffer formulation. Washing lab glassware. Data entry responsibilities. Other projects or responsibilities may be required. Skills: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Perform vialing, and labeling of regulated products. Maintain batch records and other documentations that are essential to be in compliance with ISO13485:2016 and MDSAP regulations. Maintain laboratory equipment and manage laboratory supplies. Receiving materials (inspection, organizing/labeling, & updating logs). Printing labels for final product production. General buffer formulation. Washing lab glassware. Data entry responsibilities. Other projects or responsibilities may be required. Minimum Qualifications Education and Experience Associate's Degree in Biology, Biochemistry, Chemistry, or other related area. 0-6 months of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment. Demonstrated ability to be detail-oriented, organized, work well in small work groups and the ability to adhere to timelines. Knowledge of Good Documentation Practices. Knowledge of aseptic techniques in biosafety cabinet. Ability to pipette small volumes. Ability to perform simple math calculations. Ability to communicate effectively both orally and in writing Preferred Qualifications Education and Experience 2 years of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment. Working experience in Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus. Advance pipetting skill is highly preferred. Familiar with raw material supply receiving and inspection process.

Job DescriptionAbout Capricor Therapeutics Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a cutting-edge biotechnology company focused on the discovery and development of novel therapies for the treatment or prevention of rare diseases. Our lead product candidate, allogeneic Cardiosphere-Derived Cells (CDCs), known as CAP-1002, is being investigated as a treatment for Duchenne muscular dystrophy. Additionally, we are advancing our exosomes platform technology for inflammatory indications and developing a novel vaccination approach against COVID-19. Capricor is undergoing a manufacturing technology transfer to produce CAP-1002 for late-stage clinical trials and establish a commercial-scale process, while also developing manufacturing processes for exosome-based vaccines. Join our expanding team to contribute to transformative therapies that address unmet medical needs. Position Overview The Warehouse Supervisor directly manages warehouse teams and ensures day-to-day operations meet regulatory, quality, and efficiency standards. Reporting to the Warehouse Manager, this role involves overseeing team performance, compliance, process improvements, and coordination across departments in a dynamic GMP environment. The ideal candidate is a highly motivated leader with strong supervisory experience in warehouse and logistics operations, capable of driving results while adapting to business needs in a collaborative biotech setting. Responsibilities * Capable of performing all warehouse activities to support operations as needed. * Manages team scheduling, performance evaluations, and conducts audits to maintain high standards. * Initiates and completes investigations, corrective and preventive actions (CAPAs) to address issues promptly. * Initiates and completes change controls and supports their implementation. * Updates and creates Standard Operating Procedures (SOPs) and work instructions. * Oversees investigations and resolves inventory discrepancies. * Reviews metrics and leads process improvements to enhance efficiency. * Coordinates with internal departments and ensures team training compliance. * Supports multiple warehouses, including being onsite and traveling between sites as required. * Flexible with shifts and hours to support business needs (e.g., first shift, staggered shifts, and future changes for development and expansion projects). * Conducts meetings utilizing Microsoft Teams, Outlook, and collaborates with partners to drive results. * Supports data collection for Key Performance Indicators (KPIs) in warehouse operations. * Performs all tasks as needed when assigned by the Warehouse Manager. Requirements * Education: GED or Diploma required; Associate’s or Bachelor’s degree preferred. * Experience: * 7+ years in warehouse operations, including 2+ years in a supervisory role; equivalent combination of experience considered. * 4+ years with adept understanding of cGMP, cGDP, and ISO 9001 in biotech, pharma, or related fields. * 2-4+ years in supply chain and logistics. * 2-4+ years operating forklift, box trucks, and associated warehouse equipment. * 2-4+ years in shipping cGMP and cold chain shipping experience. * 2-4+ years with DOT 49CFR and IATA regulations. * 2-4+ years managing staff. * Technical Skills: Strong proficiency in ERP systems and compliance documentation. * Competencies: * Drives Results: Demonstrates accountability and achieves goals under challenging conditions. * Collaborates: Builds relationships and works effectively with others. * Plans and Aligns: Strategically prioritizes tasks and anticipates obstacles. * Manages Ambiguity: Maintains composure in uncertainty and adapts quickly. * Courage: Addresses difficult issues with confidence. * Manages Complexity: Analyzes information for sound decisions. Work Environment and Physical Demands * Setting: Primarily warehouse-based with some office activities, focusing on logistics, inventory management, and team oversight in a GMP-compliant facility. * Physical Requirements: Ability to stand or walk for extended periods; frequently lift or move objects up to 50 pounds; operate warehouse equipment such as forklifts and box trucks; use arms, hands, and fingers to handle, feel, or reach; ability to climb, balance, stoop, kneel, or crouch as needed; travel between sites and flexibility with shifts. Why Capricor? Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that’s changing lives—help us shape the future of healthcare. Compensation (USD) * Salary Range: Competitive, commensurate with experience. * Benefits: Comprehensive benefits package, including health insurance, retirement plans, equity awards, and opportunities for professional development. Come Work with Us! At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.

Job Description Invivoscribe is an industry pioneer and global leader in precision oncology diagnostics. For more than 30 years we have driven international standardization of molecular and flow cytometry testing and expanded access to advanced cancer therapies worldwide. Our mission is simple and unwavering: Improving Lives with Precision Diagnostics ® We are looking to add a Quality Control Laboratory Associate II, who will be responsible for ensuring that only quality products are released for distribution. It is a QCLAII’s job to ensure that products are tested to meet the applicable government regulations and industry standards. The Quality Control Laboratory Associate II is also responsible for assisting investigations, stability studies, projects, Field Actions, post-market surveillance, statistical quality control activities, and maintenance of GMP environment. This position is also responsible for resolving customer inquiries and complaints. Headquartered in San Diego, with operations across North America, Europe, and Asia, Invivoscribe develops and manufactures a comprehensive portfolio of molecular and flow cytometry assays, reagents, controls, and bioinformatics tools under ISO 13485 design control. Our products and services support more than 700 clinical laboratories in over 160 countries. Core Responsibilities Include: • Effectively maintains the Standard Operating Procedures (SOP), acceptance criteria, etc., for the department and the products tested., • Effectively and efficiently executes testing to support QC release or stability assessment of raw reagents, and in- process and final products., • Assists with Installation Qualification (IQ)/ Operational Qualification (OQ)/ Performance Qualification (PQ) and validations., • Assists with troubleshooting and root cause analysis., • Assists in addressing and documenting product inquiries and complaints, including analysis, troubleshooting, and completing complaint documentation., • Assists with record review for accuracy and completeness., • Assists with post-market surveillance and Field Action Assessments (FAAs)., • Maintains Quality Control reagent inventory, including execution of electronic transactions and adjustments., • B.S. degree in a scientific discipline and, typically, 2+ years of experience in biotechnology, chemistry, or pharmaceutical QC laboratory to include 1+ year(s) of molecular biology experience in a GMP regulated industry. Equivalent combination of education and experience will be considered., • Equivalent combination of education and experience may be considered., • Working knowledge of polymerase chain reactions, gel electrophoresis, capillary electrophoresis, next generation sequencing, DNA/RNA isolation and purification, and cDNA synthesis., • Working knowledge of the following equipment is preferred: 3500xl Dx, ABI 7500 Dx, PGM Dx, S5 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, LabChip Gx, NanoDrop Spectrophotometer, iBright, and single and multichannel pipettes., • Working knowledge with medical device quality and regulatory requirements including QSR and ISO quality system standards, the IVD Directive and the IVD Regulation is preferred., • 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.

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. As a Manufacturing Technician, you’ll be a vital part of Capricor’s efforts in delivering therapies for patients in need. Supporting critical clinical trialscommercial production, you’ll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You’ll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor’s therapeutic success. This role is a full time position on our Manufacturing team, this position will be a 2-2-3 work schedule. Responsibilities • Maintaining cleanroom inventory, performing material transfers and cleanroom-required activities to support cGMP operations (i.e restocking Kanban, scrubs, and gowning), • Ensuring clear communication and working closely with manufacturing and materials management to confirm proper materials are stocked accordingly;, • Performing cleanroom setup and shutdown (Biohazard waste decontamination, packaging and autoclaving of required materials/supplies, etc), • Performing special manufacturing projects, • Completing required documentation with proper cGMP recording of entries and comments on batch records, forms and protocols independently;, • Operation, Maintenance, and Cleaning of GMP equipment, including: Centrifuges, Microscopes, Incubators, BSCs, Refrigerators, Freezers, etc, • Initiate minor revisions to existing documents, to troubleshoot simple existing procedures, and to contribute to continuous improvement initiatives., • Performing such other duties as may be assigned from time to time. Requirements, • High school diploma or GED required, • Bachelor’s degree in Biology, Biological Sciences or related field preferred, • 0-1 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting, • Lift, push, pull and carry up to 40 lbs., • Excellent knowledge of aseptic technique and aseptic practices, • Excellent knowledge of Good Documentation Practices, • Exceptional communication and interpersonal skills, • Excellent organizational skills and attention to detail, • Excellent interpersonal skills, team player, • Ability to work in a dynamic environment, • Adaptable/flexible with work schedule with an ability to multi-task and prioritize work, • From time-to-time extended hours may be required with or without notice, dependent on the work needed 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 Quality Control Associate for Environmental Monitoring (EM) plays a critical role in maintaining the environmental conditions required for GMP manufacturing. This position is responsible for performing routine and specialized sampling, analyzing trends, documenting results, and ensuring controlled areas maintain compliance with regulatory and internal quality standards. As part of the QC EM team, you will perform hands-on monitoring of air, surfaces, and personnel, as well as water system and utility testing to ensure facility integrity. You will be responsible for maintaining accurate, real-time documentation and supporting investigations into any environmental excursions or anomalies. Working closely with QC, QA, and Production, this role ensures that manufacturing and testing environments remain in a constant state of control to support the production of high-quality therapeutic products.Responsibilities • Conduct routine environmental monitoring in controlled and classified areas in alignment with GMP, ISO, and regulatory requirements., • Perform sampling of air, surfaces, water, and equipment using approved methods., • Document sampling activities and results accurately in accordance with GMP and data integrity standards., • Analyze environmental monitoring data to identify trends, excursions, and required corrective or preventive actions., • Escalate atypical results promptly and support the investigation, documentation, and closure of deviations and CAPAs., • Maintain calibration, readiness, and routine upkeep of environmental monitoring equipment., • Support audit and inspection readiness through compliant documentation and area oversight., • Collaborate with QC, QA, and Production to address findings, implement improvements, and maintain a state of control., • Follow gowning and cleanroom entry procedures consistently and perform duties in full cleanroom attire., • Participate in continual learning, safety programs, and ongoing process improvements.Required Qualifications, • Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field., • 2–5 years of experience in environmental monitoring or quality control within a regulated environment (pharmaceutical, biotech, medical device, or similar)., • Knowledge of GMP, ISO, FDA expectations, and environmental monitoring standards., • Experience performing environmental sampling and handling EM equipment., • Strong documentation, data integrity, and analytical skills., • Ability to work effectively in controlled environments, including cleanrooms., • Strong organizational and time‑management skills for handling multiple priorities.Preferred Qualifications (Nice‑to‑Haves), • Experience with viable and non‑viable particle monitoring, active air sampling, and cleanroom incubation workflows., • Familiarity with LIMS or other laboratory information systems., • Experience supporting audits, inspections, or EM program review., • Strong communication and cross‑functional collaboration skills., • Experience with troubleshooting trends or environmental anomalies.Work Environment & Physical Demands, • Significant time spent in GMP cleanrooms, including full gowning., • Prolonged standing during sampling activities and extended computer use for documentation and trending., • May require lifting of equipment or materials up to 20 pounds., • Ability to work within laboratory, cleanroom, and manufacturing environments as part of routine monitoring.Shift/Schedule, • Primary shift options:Sunday through Thursday \u007C Tuesday through Saturday, • Typical hours: 12:00 PM to 9:00 PM (may vary based on business needs), • Flexibility is required, and occasional adjustments to shift times or days may be necessary. 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 Job Title Regulatory Consultant (Part-Time, Remote) Company ViroMissile, Inc. Location Fully remote (U.S. preferred) Commitment 5–10 hours per week, flexible scheduling, through IND filing of the next clinical candidate (anticipated 3–6 months) Position Overview ViroMissile is a clinical-stage biotechnology company developing next-generation oncolytic virus immune-therapies for solid tumors. We are seeking an experienced Regulatory Consultant to provide high-level strategic guidance on clinical development and regulatory pathways for our pipeline programs. You will serve as the primary regulatory strategist, working closely with our internal clinical, CMC, and translational teams to design efficient, approvable development plans that leverage expedited programs (Fast Track, Breakthrough Therapy Designation, Accelerated Approval) and position our candidates for success in oncology. Key Responsibilities • Lead the development and execution of regulatory strategies for one or more clinical-stage oncolytic virus programs from current stage through IND filing of the next candidate., • Advise on optimal clinical trial designs, endpoints, and patient populations to support regulatory interactions and expedite approval pathways in oncology., • Prepare and/or review briefing packages, meeting requests, and responses for FDA interactions (pre-IND, IND, EOP1, EOP2, pre-NDA/BLA)., • Guide strategy for expedited designations (Fast Track, Breakthrough Therapy, RMAT if applicable) and Accelerated Approval pathways, including surrogate endpoint justification and confirmatory study planning., • Provide regulatory intelligence on evolving FDA/EMA guidance relevant to oncolytic viruses and advanced therapies., • Collaborate with the internal team to ensure alignment between clinical, manufacturing, and nonclinical plans and regulatory expectations., • Minimum 10 years of regulatory affairs experience in the biopharmaceutical industry, with direct involvement in all phases of development (IND through NDA/BLA)., • Strong track record in oncology drug development (cell/gene therapy experience highly valued)., • Demonstrated success obtaining and maintaining FDA expedited programs: Fast Track, Breakthrough Therapy Designation, and/or Accelerated Approval., • Deep familiarity with FDA regulations, guidance documents, and meeting processes (Type B/C meetings, pre-IND, etc.)., • Direct experience with oncolytic viruses, viral vector therapies, or other live-virus products., • Prior consulting or fractional regulatory leadership experience in small biotech companies., • Competitive hourly consulting rate commensurate with experience., • Opportunity to make a significant impact on the development of potentially transformative cancer therapies., • Fully remote, flexible engagement with a lean, science-driven team. ViroMissile, Inc., is an equal opportunity employer.

Job DescriptionDescription: Company Overview: Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space. We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression. Vividion has been recognized as a Top Workplace by The San Diego Union-Tribune from 2022 to 2025. Job Summary: As a senior member of the Vividion chemistry department, the successful candidate will be able to contribute to all priority phases of the drug discovery process including library growth, hit identification, hit to lead, and guide lead optimization programs to successful Development Candidate nominations and IND submissions. The preferred candidate will be comfortable balancing traditional approaches, exploring novelty on the cutting edge of modern small-molecule drug discovery, and have a thirst to constantly learn. Requirements: Education and Experience requirements: • PhD in synthetic organic chemistry with 8+ years of industry experience in small molecule drug discovery with a clear understanding of program strategy, therapeutic hypothesis, assay relevance and clinical translation, and the importance of physical-chemical properties as it relates to enabling late-stage in vivo studies and clinical dosing., • A clear command of classical and modern synthetic methodology and reaction mechanism., • Expertise to craft compounds that fully exploit insights from ligand and/or structure-based design while fully exploiting all available synthetic methods., • Proven leadership skills within and across multiple functions as part of integrated drug discovery teams as exemplified by delivery of development candidate small molecules., • Experience in mentoring and managing both internal junior chemists and outsource chemistry resources., • Curiosity, • Fearlessness, • Creativity, • Attention to detail The anticipated base salary for this position ranges from $165,000 to $180,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance. EEO & Employment Eligibility: Vividion Therapeutics, Inc. is an equal opportunity employer. All applicants will receive consideration for employment without regard to disability or veteran status. Privacy Policy: The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit .

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

Job DescriptionSalary: Who Are We? Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diegos Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients. Who Are You? You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently. What is the Primary Objective of the Sr. Staff Accountant? The Senior Staff Accountant is responsible for performing general accounting tasks (multi-company) in accordance with Generally Accepted Accounting Principles (GAAP) and company policies. Work may include month end close, posting and reconciling general ledger accounts, accounts payable, accounts receivable, fixed assets, payroll, banking, inter-company transactions, account reconciliations, clinical investigator payments and other accounting responsibilities as assigned. Your Main Responsibilities and Duties Include: • Bi-weekly payroll (multi-state); preparation and entry of payroll journal entries and monthly reconciliation and allocation of employee benefits., • Accounts receivable; code and enter assigned monthly billing and send with all supporting documentation, track payments and follow-up on collections., • Enter invoices into accounting system and update assigned billing workbooks for investigators and other out-of-pocket expenses., • Clinical study tracking: accrue revenues and associated expenses for assigned clinical study activities performed Cross-Trained Responsibilities Coordinated with Department Staff: • Accounts payable; verify, code, enter, obtain approvals and process for payment in a timely manner., • Maintain accounts payable files., • Implementation and maintenance of expense reporting through Concur., • General ledger accounting: generate and input all journal entries in compliance with GAAP, maintain appropriate supporting documentation and reconcile all accounts., • Process intercompany transactions., • Fixed assets; administration, tracking, depreciation and reconciliation., • Calculate and track all payments to investigator sites., • Maintain Sunshine Act reporting., • Prepare and file property and sales and use tax returns., • Maintain petty cash., • Perform other duties as needed. To Succeed in this Position: • You will have a Bachelor of Science degree in Accounting., • You will have a minimum of six (6) years of related experience., • You should have biotechnology/CRO experience. While not required, it is preferred., • You will have the ability to communicate well, both orally and written., • You will possess the knowledge of accounting principles, practices, procedures and internal controls., • You must have integrated accounting software experience., • You should be proficient in QuickBooks and ADP. While not required, it is preferred., • You must have advanced proficiency in Excel., • You must have public accounting or experience with third-party auditing., • You should be well organized with ability to work independently in a fast-paced environment., • You should be versatile, flexible and be willing to work within constantly changing priorities. The most likely starting base pay range for this position is $85,000 to $118,000 per year. Several factors, such as experience, tenure, skills, and business needs will determine an individuals exact level of compensation. Consideration will be given to experience that exceeds the listed requirements. **Please note the candidate must be currently residing in San Diego, CA. We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. If you are smart and good at what you do, we welcome you to apply!

Job DescriptionAssociate General Counsel Fully Remote | Fast-Growing Biotech/Pharma Company Compensation: $200,000 – $300,000 Base + More Join a mission-driven biotech company transforming the future of rare autoimmune disease treatment. We’re developing innovative therapies for patients who need them most—and we’re looking for a strategic legal partner to help guide our growth. About the Role We’re adding an Associate General Counsel to our dynamic legal team. Reporting directly to the General Counsel, you’ll be a key business partner across the company, providing practical legal advice, driving compliance initiatives, and ensuring that we move fast while staying grounded in ethics and integrity. This is an opportunity to do meaningful work at the intersection of science, law, and business—where your impact will be felt across patients, employees, and the broader healthcare community. What You’ll Do * Keep Us Compliant: Navigate the complex biotech regulatory landscape and ensure we’re ahead of the curve on evolving laws. * Strengthen Our Culture of Integrity: Develop and deliver engaging training on compliance topics—from our Code of Conduct to anti-bribery and anti-kickback rules—while continuously refining company policies. * Be a Deal-Maker: Draft, review, and negotiate critical agreements (clinical trial, licensing, manufacturing, research collaborations, vendor, and more). * Enable Commercial Success: Partner with the commercial team to review promotional materials, advertising, and other go-to-market initiatives. * Protect and Empower: Spot legal risks early, propose smart solutions, and balance business agility with compliance. * Collaborate Across Teams: Work side-by-side with colleagues in R&D, Regulatory Affairs, Quality, HR, Finance, and Commercial to deliver clear, actionable guidance. * Be a Trusted Advisor: Foster trust at every level of the organization, championing ethical business practices and sound judgment. What You’ll Bring * JD (or equivalent) with active bar membership in good standing. * 10+ years of legal experience in biotech, pharma, or life sciences (in-house or at a top firm advising clients in these sectors). * Deep knowledge of the regulations shaping the biotechnology industry. * Proven success drafting and negotiating complex agreements. * Familiarity with global privacy frameworks (e.g., GDPR). * A reputation for providing clear, business-oriented legal counsel in fast-moving environments. * Exceptional communication and relationship-building skills—you can talk science with scientists, strategy with executives, and compliance with employees. * Impeccable ethics, attention to detail, and the ability to juggle multiple priorities without losing focus. Why Join Us? This isn’t just another legal role. It’s a chance to help shape a high-growth biotech company as it brings life-changing medicines to market. You’ll work with passionate, driven colleagues in a collaborative environment where your voice matters and your work has a direct impact on patients’ lives. If this sounds like something you are interested in, apply today!

Job Description Job Description: The Principal Scientist, Toxicology will provide scientific and operational leadership for non-clinical toxicology activities supporting drug discovery and development programs. This role is responsible for the strategic design, execution, oversight, interpretation, and reporting of outsourced GLP and non-GLP toxicology and related nonclinical studies to support global regulatory submissions. Essential Responsibilities: Study Monitoring & Nonclinical Oversight • Serve as Study Monitor with responsibility for oversight of all phases of outsourced GLP and non-GLP studies, including study enabling activities, study setup, protocol development, on-site monitoring of study conduct at CRO sites, and review of data and reports., • Provide scientific guidance, feedback, and directives to Study Directors and non-clinical sub-team members, including coordination of:, • CMC/Formulation planning to support study requirements, including manufacture, release testing, and shipping, • Sample shipping and logistics in collaboration with Operations, • Study timeline development in partnership with Project Management, • Maintain GLP compliance for all aspects of GLP studies and ensure adherence to internal SOPs and regulatory expectations., • Archive final study reports and associated data in IQVIA in accordance with regulatory and company requirements., • Collaborate closely with multidisciplinary drug discovery and development teams including CMC, Clinical, Regulatory Affairs, Pharmacokinetics, Bioanalytical, and Project Management., • Interface with drug safety team leads and represent toxicology as the primary point of accountability for the design, execution, data interpretation, and reporting of in vivo toxicokinetic (TK), tolerability, and investigative studies., • Develop protocols, procedures, data templates, and report templates for non-GLP studies and ensure submission-ready study reports to support advancement of drug candidates., • Contribute to and/or author nonclinical sections of global regulatory filings, including Pharmacology, PK, and Toxicology sections for INDs, NDAs, Marketing Applications, and regulatory briefing documents., • Oversee and manage CRO performance, timelines, budgets, and deliverables to ensure high-quality outcomes., • Contribute to budget estimates for nonclinical studies and ensure actual costs remain aligned with projected budgets on a quarterly and annual basis. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • PhD in Toxicology, Pharmacology, or a related life science discipline (DVM or equivalent may be considered), • 8+ years of relevant experience in pharmaceutical or biotechnology drug development, with demonstrated leadership in nonclinical toxicology, • Extensive experience overseeing outsourced GLP and non-GLP toxicology studies, • Direct experience supporting IND and later-stage regulatory submissions, • Strong knowledge of global nonclinical regulatory requirements (FDA, EMA, ICH), • Proven ability to lead cross-functional teams and manage external vendors, • Excellent scientific writing, communication, and presentation skills, • Must be able to work independently as well in cross-functional team settings with supervision as needed., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job DescriptionDescription: About the Company As a life science company and a leading supplier to global research markets, we offer a comprehensive product portfolio along with outstanding hands-on customer service to ensure every laboratory has the tools and support they need. Our markets include pharmaceutical and biotechnology businesses, research institutions, hospitals, reference labs, and more. Be part of making a difference At Genesee, we believe we can help improve our communities and transform the world through science. Our shared desire to make a difference is what drives and inspires us. We are a fast-growing, dynamic team that listens to each other and embraces collaboration. We foster an open, friendly work and show up for one another every day. Role: Account Manager Reports to: Regional Sales Director FLSA: Exempt Location: Philadelphia, PA Why this role is important at Genesee Scientific? Our Account Managers are responsible for the sales of research products within a defined territory. You will develop and maintain effective customer relations, drive opportunities for growth within an existing customer base, and assure market penetration and profitability while achieving sales and profit forecasts. This is an excellent opportunity for an energetic professional who is looking to gain sales experience with a rapidly growing company. What will you do: • Take ownership of territory to build and sustain strong customer relationships, • Manage pricing in territory to achieve financial targets, • Independently make decisions while leveraging available resources to fulfill customer, fostering seamless collaboration with cross functional teams, • Monitor competitor and industry activity, staying updated on new products/services and relevant customer information to integrate into the business plan, • Maintain detailed and timely activity logging in Salesforce, including customer interactions, opportunities, and pipeline management to ensure data accuracy and visibility, • Provide customers with updates on supply and price trends, aiding inventory management, and offer consultative support, • Deliver updates on supply and pricing trends while providing consultative support to customers on inventory planning, • Leverage Teams and Zoom for virtual demos and sales presentations to expand reach and optimize travel time, • Bachelor’s degree in a relevant science field or equivalent experience, • 3+ years sales or research laboratory industry, or lab experience preferred, • Strong verbal and written communication, negotiation, and presentation skills with a proven ability to effectively deliver sales and marketing information that influences customer decision-making, • Able to work effectively both independently and as part of a team, with comfort conducting virtual sales presentations and product demonstrations via video conferencing platforms (Zoom, Teams), • Proficient in Microsoft Office and Teams with working knowledge of Salesforce or similar CRM tools for data management and reporting, • Results orientated, strong work ethic and an ability to excel within a rapidly changing and growing organization, • Occasional lifting of promotional materials and product displays (up to 25 lbs.) during trade shows and events, • Ability to stand and walk for extended periods during customer visits, trade shows, and tabletop events, • Travel up to 25% within the territory, primarily by car, with occasional overnight travel, • Training and professional growth initiatives, including comprehensive onboarding programs for new team members, • We provide financial well-being with competitive compensation packages and 401 (k) retirement savings plans, • Health care and well-being programs including medical, dental, vision, life, short- and long-term disability and employee assistance programs Employment offers are subject to successful completion of a background check and pre-employment drug test. Genesee Scientific is proud to be an Equal Employment Opportunity employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Quality Systems Specialist (Veeva) is responsible for supporting Capricor’s transition to the Veeva electronic Quality Management System (eQMS) and providing ongoing system administration, configuration, and maintenance. This role plays a key part in ensuring the eQMS meets GxP, regulatory, and operational requirements while enabling efficient and compliant quality processes.The Specialist will support implementation activities, system configuration, validation, user support, continuous improvement, and cross‑functional collaboration. This is a highly visible role critical to Capricor’s modernization of quality systems and digital infrastructure.Responsibilities * eQMS Transition & Implementation • Co‑lead the transition from the legacy QMS to Veeva eQMS, supporting planning, execution, and go‑live readiness., • Participate in system implementation activities including:, • Gathering and documenting user and business requirements (URS)., • Configuration of Veeva Vault Quality modules (QMS, Docs, Training)., • Data migration planning, mapping, execution, and verification., • Coordinate and support system validation activities (IQ/OQ/UAT), including documentation and testing oversight., • Support hypercare and post‑implementation stabilization activities., • Configure and maintain quality workflows, lifecycles, roles, permissions, and security settings., • Manage configuration of Veeva processes including Deviations, CAPA, Change Control, Training, and Document Control., • Maintain metadata structures, document hierarchies, and controlled vocabulary., • Serve as a Veeva eQMS System Administrator for Capricor., • Support Veeva releases by performing impact assessments, regression testing, and required documentation updates., • Manage system issues, enhancements, and change requests in partnership with Veeva Support., • Identify opportunities to enhance system usability, workflow efficiency, and user experience., • Analyze system metrics (cycle times, overdue items, trending data) to drive optimization., • Conduct user training sessions, onboarding, and refresher training for Veeva Vault applications., • Serve as a Veeva eQMS Subject Matter Expert (SME) to support end users with troubleshooting and best practices., • Provide guidance on system usage to ensure compliance and data integrity.Required Skills, • Education & Experience: Bachelor’s Degree and 5+ years of experience in a pharmaceutical, biologics, or FDA‑regulated environment., • Certification: Veeva Vault certifications (Administrator, Quality Suite) or equivalent hands‑on experience administering and configuring Veeva Vault., • Quality Background: Minimum 3+ years of Quality Assurance or Quality Systems experience in a GMP‑regulated environment., • Regulatory Knowledge: Knowledge of GxP regulations and industry guidance including 21 CFR Part 11, 210, 211, and ICH Q8/Q9/Q10., • Technical Skills: Experience supporting system implementation, validation, configuration, and release management activities., • Soft Skills: Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non‑technical stakeholders., • Tools: Proficiency with Microsoft Office applications.Preferred / Nice-to-Have Skills, • Experience migrating from a legacy QMS to Veeva Vault., • Understanding of electronic signatures, data integrity principles, and audit trail requirements., • Experience working with IT, Validation, and QA teams on system qualification activities., • Prior involvement in developing SOPs, workflows, or training content for eQMS systems., • Strong analytical and problem‑solving abilities with experience interpreting system metrics.Work Environment / Physical Demands, • Primarily office‑based with extensive computer use for system configuration, documentation, and administration., • Ability to sit for extended periods while working on system or documentation tasks., • Occasional lifting of 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 DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Job Summary: The Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of the Clinical Trial Manager(s). The CRA works closely with the clinical trial team to ensure site related start-up through close-out activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The CRA may assist with vendor oversight and management. They will identify issues in a timely manner and escalate to management as appropriate. The CRA may complete monitoring visit report review and perform co-monitoring. The core duties and responsibilities of the CRA are delineated below. Duties/Responsibilities: • Organizes, and supports trial managers, in conduct of all study team via agenda and meeting minute preparation, completion and distribution., • Manages Site Essential Documents review during study start-up, maintenance and close-out period, • Prepare study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.), • Ensures tracking and filing of essential documents in the appropriate tracking systems., • Ensures tracking of patient status throughout the study at investigative sites, • Responsible for maintaining internal tracking systems of patient and site status in support of trial and management needs., • May review and approve trip reports, track data query reports, site visit metrics, and overall site performance, • May perform routine monitoring at limited clinical sites, • May perform site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with local CRAs, • Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues, • May assist in the preparation of, and may present at investigator vendor meetings and workshops, • Actively involved in the performance of study feasibility assessments, • Provides rapid action to address both internal and site QA findings from audits, • Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation, • Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.) Requirements: • Bachelors degree or higher, • 3 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site or hospital experience, • Previous site monitoring experience preferred, • Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures, • Understanding of study phases and general knowledge of how they apply to clinical development, • Advanced knowledge of Word, Excel, and PowerPoint., • Knowledge of the principles and practices of computer applications in database management, • Strong verbal and written communication skills required., • 20% - 30% travel may be required Why you should apply: We have a fantastic team and philosophy! We are passionate We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit.We are transparent - believers in flat, accessible, and open communication paths.We are inclusive committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: An entrepreneurial, highly collaborative, and innovative environment Comprehensive benefits, including: • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week Base Salary: $115,000 - $130,000. Exact compensation may vary based on level, skills and experience.

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: The most important aspect of the position of the Associate Director of Global Medical Affairs is being responsible for managing complex projects across medical content development, Medical / Legal / Regulatory (MLR) Review, Medical Affairs (MA) Operations & Excellence, etc. This role also serves as both Client Manager and Project Manager for these projects. Additionally, this individual will be part of the MA leadership team that will support development of MA strategies, solution offerings, technology / innovation, and building and managing MA teams. This person will collaborate closely with other global leaders within our Global Medical Information and Medical Affairs service line and other business units across EVERSANA to further strengthen the vision of an Integrated Medical Affairs solution offering. This person may partner with other Medical Affairs leads by managing multiple complex deliverables for internal and external clients with a team of resources, including both full-time employees and consultants. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: Project & Client Management • Lead and manage complex, cross-functional Medical Affairs projects, including medical content development, MLR (Medical/Legal/Regulatory) review processes, MA operations, and MA consulting., • Serve as the primary Client/Project Manager for assigned client projects, ensuring timely delivery, quality standards, and strategic alignment with client objectives., • Contribute to the development and execution of Global Medical Affairs strategies, aligning with broader organizational goals and client needs., • Actively participate in the MA leadership team to shape solution offerings, drive innovation, and support business growth., • Support the design and implementation of scalable Medical Affairs models and frameworks across therapeutic areas and geographies., • Lead and manage the development of the positioning and marketing information related to EVERSANA’s Medical Affairs Excellence & Strategy and related consulting services. Including, oversight of capabilities presentations, development of case studies, white papers, publications, and information on EVERSANA.com., • Drive continuous improvement in Medical Affairs operations, including process optimization, technology adoption, and performance metrics., • Champion the integration of digital tools and platforms to enhance medical content delivery, stakeholder engagement, and operational efficiency., • Partner closely with leaders across Global Medical Information, Global Medical Affairs, and other EVERSANA business units to deliver integrated, best-in-class solutions., • Facilitate cross-functional alignment and communication to ensure consistency and excellence in Medical Affairs deliverables., • Build, mentor, and manage high-performing Medical Affairs teams, fostering a culture of collaboration, accountability, and professional growth., • Support recruitment, onboarding, and training of new team members (FTEs and consultants) to ensure capability alignment with evolving business needs., • Cultivate Trusted Partnerships: Build and maintain strong, long-term relationships with client stakeholders, acting as a strategic advisor and trusted partner in Medical Affairs transformation., • Client Satisfaction & Retention: Monitor client satisfaction through regular check-ins, feedback loops, and performance reviews; proactively address concerns to ensure high retention and repeat business. EXPECTATIONS OF THE JOB: • Hours: Monday-Friday, 40+ Hours/week 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. • Medical / Scientific degree, PharmD, MD, PhD, etc., • 5+ years of experience in Medical Affairs within the pharmaceutical, biotechnology or device/diagnostics industry, • Demonstrated experience with project management, including vendor and / or technology management, • Experience with Medical Affairs Operations and Excellence across Medical Information, Medical Communications, HEOR, Investigator Initiated Studies, Independent Medical Education, Evidence Generation, etc., • Results driven and team-oriented, with the ability to influence outcomes as necessary, • Able to innovate, analyze, and solve problems with minimal supervision. Passion for technology, innovation (including AI), and process improvement, • Exceptional attention to detail and communication skills, • Demonstrated ability to manage multi-client projects simultaneously while advancing company goals / initiatives, • Ability to communicate and interact effectively with clients 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. 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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. Capricor is seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The Quality Assurance QA Associate II – Quality Events Team (QET) is responsible for cross-functional triage of issues and managing, investigating, and resolving deviations, non-conformances, and corrective and preventive actions (CAPAs) in compliance with cGMP, SOPs, and regulatory requirements. This role ensures the consistent application of quality standards across manufacturing, laboratory, and clinical operations while supporting continuous improvement initiatives. The position will report to the Manager of Quality Assurance. Position: Quality Assurance Associate II- Quality Events Team (Hybrid) 2nd shift, 3pm-1130pmResponsibilities: • Review, investigate, and manage deviations, non-conformances, and CAPA activities across the organization., • Conduct root cause analyses (RCA) and risk assessments for reported quality issues., • Collaborate with cross-functional teams (Manufacturing, MSAT, QC, Clinical, and R&D) to ensure timely resolution of quality events., • Track and maintain documentation of deviations and CAPAs in compliance with cGMP, FDA, and other applicable regulatory guidelines., • Monitor trends in deviations and CAPAs to identify systemic issues and recommend preventative measures., • Assist in preparing and supporting internal and external audits and inspections., • Develop, update, and maintain SOPs and quality documentation, including but not limited to those related to deviations and CAPA processes., • Provide training to staff on deviations, deviation reporting, and CAPA procedures., • Support continuous improvement initiatives by identifying opportunities to enhance quality processes., • Host/Lead Deviation Review Board (DRB) meetings., • Triage with cross-functional teams to ensure issues are resolved in a timely, quality manner.Requirements:, • Education: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field., • Professional Experience: Minimum of 3 years of experience in Quality Assurance within a biotech, pharmaceutical, or related industry., • Strong knowledge of cGMP regulations, FDA/EMA guidance, and industry quality standards., • Proven experience managing deviations, investigations, and CAPA processes., • Excellent analytical, problem-solving, and root cause investigation skills., • Strong written and verbal communication skills, with the ability to prepare clear, compliant documentation., • Ability to work independently and as part of a team., • Attention to detail, organizational skills, and the ability to prioritize multiple tasks in a fast-paced environment.Work Environment & Physical Demands, • Professional office environment (San Diego, CA) and remote work setup for 2nd shift (M-F, 3pm-1130pm). 3 days a week in office at our headquarters in San Diego, CA., • Occasional weekend work may be required Notice to Recruiting AgenciesCapricor 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 Quality Systems Associate will support and maintain Capricor’s Quality Management System (QMS) to ensure compliance with FDA, GMP, ISO 9001, and internal quality standards. This role will assist in document control, training, audit preparation, quality records management, and system administration while collaborating across functional teams to strengthen Capricor’s quality operations.This is an excellent opportunity for someone who is detail‑oriented, organized, and eager to grow their quality career in a fast‑paced biotech environment.Responsibilities • Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements., • Assist in document control activities, including creation, revision, routing, issuance, and archival of controlled documents., • Help manage and track corrective and preventive actions (CAPA) to ensure timely investigation, follow‑up, and closure., • Assist in preparing for and conducting internal audits; support readiness for external audits and inspections., • Coordinate and track employee training activities to ensure staff remain compliant and current with required qualifications., • Support management of deviations, non‑conformances, and audit findings, ensuring documentation is accurate and complete., • Assist with implementing and maintaining change control processes, ensuring proper documentation, review, and approval., • Collaborate with cross‑functional teams (QA, QC, Manufacturing, Facilities, R&D) to support quality system activities and improvements., • Help generate, analyze, and maintain quality metrics and trend reports to support continuous improvement., • Assist with administration of quality system software, including user access management, record maintenance, and troubleshooting., • Stay informed on evolving regulations, guidance documents, and industry best practices.Required Skills, • Bachelor’s degree in Life Sciences, Engineering, or a related field., • Minimum 2+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.)., • Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards., • Strong attention to detail and organizational skills., • Ability to work independently and collaboratively in a fast‑paced environment., • Proficiency in Microsoft Office (Word, Excel, PowerPoint)., • Experience with QMS or electronic quality system software platforms., • Strong written and verbal communication skills for effective cross‑functional collaboration.Preferred / Nice-to-Have Skills, • Experience supporting audits, CAPA processes, deviations, or change control., • Familiarity with electronic document management systems (EDMS) or commercial QMS tools., • Experience in a GMP manufacturing, biologics, or cell therapy environment., • Exposure to ISO audit practices or participation in internal audits., • Ability to analyze quality data, produce reports, and identify trends.Work Environment / Physical Demands, • Primarily office‑based, focusing on quality system management and documentation activities., • Requires prolonged periods of computer use for documentation, reporting, and system administration., • 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 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 an experienced NetSuite Administrator to manage, maintain, and optimize our NetSuite ERP system within a regulated pharmaceutical environment. This role is critical to ensuring system integrity, GxP compliance, audit readiness, and adherence to SOX/internal control requirements.The ideal candidate brings deep NetSuite expertise combined with experience operating in FDA-regulated or compliance-heavy environments. This individual will serve as the subject matter expert for NetSuite and partner cross-functionally with Finance, IT, Quality, and Operations to drive scalable, compliant solutions.Key Responsibilities • ERP Administration & Optimization, • Administer and maintain NetSuite ERP in a validated environment, • Configure workflows, saved searches, dashboards, reports, and custom fields, • Manage sandbox testing, upgrades, and release management, • Support multi-entity and multi-subsidiary structures, • Oversee integrations and data imports while ensuring data integrity, • Compliance & Validation, • Ensure system compliance with GxP, SOX, and internal control requirements, • Support system validation activities, • Maintain SOPs, configuration documentation, and audit trails, • Participate in internal and external audits, • Manage change control processes and documentation, • Conduct user access reviews and enforce segregation of duties (SoD), • Financial & Operational Support, • Partner with Finance to support month-end, quarter-end, and year-end close, • Maintain audit-ready reporting and system documentation, • Support compliance reporting and traceability requirements, • Provide structured end-user training within a controlled environmentMinimum Qualifications, • 3+ years of NetSuite administration experience, • Experience in pharmaceutical, biotech, medical device, or other regulated environments, • Strong understanding of GxP and/or SOX compliance frameworks, • Experience supporting system validation and change control, • Deep knowledge of NetSuite roles, permissions, workflows, saved searches, and reporting, • Strong documentation discipline and SOP development experience, • Excellent cross-functional communication skillsPreferred Qualifications, • NetSuite Administrator Certification, • Experience with SuiteScript, SuiteFlow, or SuiteAnalytics, • Experience supporting FDA-regulated environments, • Familiarity with 21 CFR Part 11 principles, • Experience in multi-entity or global environmentsWork Environment / Physical Demands, • 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 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 highly motivated Scientist deep expertise in in vitro assay development to support our expanding therapeutic programs. This hands‑on, lab-based role is critical in designing, developing, and executing cellular assays to evaluate exosome‑based delivery of therapeutic agents, including protein, mRNA, siRNA, ASO, and PMO. The ideal candidate brings strong technical proficiency, creative problem‑solving, and a passion for advancing novel therapeutic platforms. Experience with iPSC genome editing and differentiation into myogenic lineages is highly desirable. The role requires close collaboration across molecular biology, cell biology, and translational research teams to drive program success.Responsibilities • Design, develop, and validate mechanism‑of‑action and functional in vitro assays to assess therapeutic efficacy, potency, and safety., • Establish PK/PD assay platforms to characterize cellular uptake, expression, and downstream biological responses., • Utilize a range of assay technologies including high‑content imaging, flow cytometry, qPCR, Western blotting, and ELISA., • Develop and optimize exosome or lipid nanoparticle loading and delivery protocols for protein, mRNA, siRNA, ASO, and PMO payloads., • Characterize loading efficiency, payload integrity, delivery kinetics, and functional outcomes in vitro., • Culture and manipulate diverse mammalian cells including primary cells, immortalized lines, and iPSCs., • Perform transfection, transduction, and nucleic acid delivery followed by molecular and functional analyses., • Support CRISPR/Cas9 or related gene editing workflows., • Develop and apply disease‑relevant in vitro models for rare muscle disorders, including iPSC‑derived myoblasts., • Correlate cellular phenotypes with disease‑relevant biomarkers and therapeutic mechanisms., • Troubleshoot and optimize complex assay workflows and delivery methodologies., • Analyze and interpret data; prepare clear presentations and written reports., • Maintain rigorous documentation and data integrity standards., • Work collaboratively with research, bioanalytics, and translational teams to align assay strategies with program objectives., • Stay current with emerging technologies in drug delivery, nucleic acid therapeutics, assay platforms, and exosome science and apply innovative thinking to accelerate discovery.Requirements, • Ph.D. in Cell Biology, Molecular Biology, Biochemistry, or a related field with 0–3+ years of postdoctoral or industry experience; or M.S. with 5+ years of relevant experience., • Proven hands‑on experience in in vitro assay design, development, and validation for therapeutic evaluation., • Proficiency with mammalian cell culture, including primary cells, immortalized lines, and (ideally) iPSCs., • Experience with exosome‑based or related drug substance delivery platforms (e.g., lipid nanoparticles) for protein, mRNA, siRNA, ASO, or PMO payloads., • Technical capability with high‑content imaging, flow cytometry, qPCR, Western blotting, ELISA, and related analytical methods., • Experience performing transfection, transduction, nucleic acid delivery, and subsequent molecular/functional analyses., • Understanding of CRISPR/Cas9 genome engineering and, ideally, iPSC genome editing and differentiation into myogenic lineages such as myoblasts., • Familiarity with rare muscle disease biology, associated cellular phenotypes, and relevant biomarkers., • Working knowledge of nucleic acid and protein‑based therapeutic modalities including siRNA, ASO, PMO, mRNA, and proteins., • Strong analytical skills with proficiency in data analysis tools such as GraphPad Prism and FlowJo., • Demonstrated ability to troubleshoot complex biological systems and optimize experimental workflows., • Highly organized with strong attention to detail and excellent documentation practices., • Effective verbal and written communication skills; proven ability to work collaboratively across cross‑functional teams.Work Environment, • This is a hands‑on, on‑site laboratory role based in Capricor’s San Diego research facilities., • Work is performed using standard cell‑culture and molecular‑biology laboratory practices, including routine use of biosafety cabinets and standard PPE., • Activities may involve human‑derived cell systems, gene‑delivery tools, and complex in vitro assays, requiring adherence to established safety and documentation procedures., • The position includes regular bench work, pipetting, computer‑based analysis, and occasional lifting of items up to ~25 lbs. 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. We are seeking an individual to join our Quality Compliance department. This role conducts internal and external audits to ensure our biopharma operations comply with applicable regulations, standards, and company procedures. The ideal candidate brings hands-on GMP/GxP auditing experience within the life sciences industry and partners cross-functionally to drive continuous improvement and a strong culture of compliance.Responsibilities • Internal Audits: Plan, conduct, and report risk-based GxP audits across manufacturing, QC, labs, validation, and supply chain., • Supplier Audits: Lead and support vendor audits and monitor ongoing supplier performance, as needed., • Audit Execution: Develop audit agendas, checklists, and sampling strategies aligned with regulatory expectations., • Reporting & CAPA: Issue clear audit reports, classify findings, and track CAPA effectiveness to closure., • Inspection Readiness: Support regulatory inspection readiness., • Gap Assessments: Assess compliance against regulations and industry standards and recommend improvements., • Cross-Functional Partnership: Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems., • Metrics & Communication: Maintain audit schedules, dashboards, and communicate status and trends to management., • Quality Improvement: Support SOP development, training, and continuous improvement initiatives., • Additional Support: Willing to support activities related to post-marketing safety and surveillance and additional responsibilities as needed.Minimum Qualifications, • Education: Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience., • Experience: 2–5 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry, including audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control)., • Regulatory Knowledge: Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GxP principles., • Communication: Strong writing skills and attention to detail; able to produce clear, evidence-based audit reports., • Technical Proficiency: Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification., • Stakeholder Management: Excellent communication and stakeholder management skills; comfortable engaging at all levels.Preferred Qualifications, • Certification: Certified Quality Auditor (CQA) – ASQ, or equivalent certification; candidates without certification must demonstrate the ability and willingness to obtain it within a defined timeframe., • Vendor Oversight: Experience auditing CMOs/CDMOs and complex supply chains., • Digital/Data: Background with data integrity, CSV, Annex 11, and Part 11 assessments., • Specialized Manufacturing: Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing., • Post-Marketing: Knowledge of ISO 9001/13485 and quality systems related to post-marketing safety and surveillance (as applicable).Core Competencies, • Integrity & objectivity in evidence gathering and reporting., • Risk-based thinking and prioritization., • Analytical problem-solving and pragmatic recommendations., • Collaboration across functions and suppliers., • Time management, organization, and follow-through.Work Conditions, • On site based in San Diego. 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.

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: Senior BD Manager Location: Onsite - San Diego Position Type: 5 days Onsite Exempt Position Salary Range: $90,000-$150,000 Job Summary: We are seeking a results-oriented Senior Business Development Manager to support CorDx’s growth initiatives by identifying new business opportunities, managing strategic partnerships, and contributing to revenue expansion within the diagnostic sector. This role will focus on market research, relationship management, and deal execution in alignment with corporate strategy. The ideal candidate will have strong experience in business development or commercial operations within the biotechnology, medical device, or pharmaceutical industries. Key Responsibilities: • Market Development & Opportunity Identification, • Identify and evaluate new business opportunities, market segments, and potential partners aligned with company objectives., • Support market entry strategies and product launch initiatives through competitive and market analysis., • Assist in developing pricing and go-to-market strategies to support new product and market growth., • Partnership Management & Deal Execution, • Manage and grow relationships with key customers, distributors, and industry partners., • Support contract negotiations, licensing discussions, and partnership agreements., • Ensure smooth execution of partnership deliverables and monitor ongoing performance., • Sales Enablement & Commercial Support, • Collaborate with Sales, Marketing, and Product teams to align business development initiatives with commercial goals., • Provide market insights and customer feedback to guide product development and marketing strategies., • Track and report on business development KPIs, deal pipeline, and revenue opportunities., • Cross-Functional Collaboration, • Work with internal stakeholders in Regulatory, Finance, and Operations to support deal execution and partnership management., • Assist in coordinating participation in industry conferences, expos, and networking events to increase market presence., • Operational & Risk Management, • Analyze financial and operational data to support business proposals and partnership opportunities., • Identify potential risks related to market shifts, competitive threats, and operational challenges, recommending mitigation strategies. Requirements • Bachelor’s degree in Life Sciences, Biotechnology, Business Administration, or a related field. An MBA is preferred., • 5–8 years of business development, sales, or strategic partnerships experience within the biotech, diagnostics, or life sciences industry., • Demonstrated ability to manage business relationships, negotiate agreements, and support revenue-driving initiatives., • Strong communication, interpersonal, and organizational skills., • Solid understanding of market trends, competitive analysis, and commercial operations within a regulated industry., • Preferred Qualifications:, • Experience in distributor management, or international business partnerships., • Familiarity with regulatory frameworks (FDA, ISO 13485) and intellectual property considerations in the biotech space., • Strong analytical skills with the ability to interpret financial models and market data., • Prior experience working in a high-growth, fast-paced environment is a plus. Benefits • Highly competitive compensation package., • Comprehensive medical insurance., • 401(k) plan., • Flexible paid time off (PTO) policy., • Additional substantial benefits.

Job Description (Associate) Director, Clinical Scientist (Remote) Key Responsibilities • Provide scientific and strategic leadership in the planning and execution of clinical trials, including protocol development, study design, and data analysis., • Author and review clinical protocols, ICFs, CSRs and regulatory documents, • Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, to ensure the successful conduct of clinical studies., • Interpret clinical data, prepare study reports, and contribute to regulatory submissions and presentations for internal and external stakeholders., • Support investigator meetings, advisory boards and data monitoring committee meetings, • Stay current with emerging scientific literature, competitive landscape, and regulatory requirements relevant to Immuneering’s oncology therapeutic area., • Support the development of clinical development plans and contribute to the strategic direction of ongoing and future programs., • Work closely with CRO’s and have a can do, proactive biotech mindset. Qualifications & Education · PhD, PharmD, RN, or MD in a relevant scientific discipline (e.g., biology, pharmacology, medicine). · Minimum of 5-8 years of experience in clinical development within the pharmaceutical or biotechnology industry. · Direct Phase 3 oncology clinical trial experience required. · Demonstrate experience authoring and reviewing clinical documents. · Demonstrated strong experience in clinical trial execution and data interpretation. · Strong analytical, organizational, and communication skills. · Deep understanding of oncology clinical development, endpoints and regulatory expectations. Technical / Soft Skills · Excellent cross-functional communication and stakeholder management. · Ability to work collaboratively in a fast-paced, team-oriented environment. · Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable) Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

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: San Diego, California Position Type: 5 days Onsite Exempt Position Salary range: $100,000-$200,000 annually. 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: • Develop and execute a comprehensive business development strategy to drive revenue growth and market expansion., • Identify and evaluate new partnerships, licensing opportunities, and collaborations with biotech firms, pharmaceutical companies, and research institutions., • Lead initiatives to expand product pipelines, service offerings, and commercialization strategies., • Establish and maintain strong relationships with key industry stakeholders, including investors, corporate partners, and regulatory bodies., • Negotiate and close strategic partnerships, joint ventures, and licensing agreements to support business goals., • Represent the company at conferences, networking events, and industry forums to enhance brand visibility and drive engagement., • Conduct market research and competitive analysis to identify trends, emerging opportunities, and potential risks., • Provide strategic insights and recommendations to senior leadership for business expansion initiatives., • Monitor industry regulations, funding opportunities, and government policies impacting the biotech sector., • Work closely with R&D, finance, marketing, and regulatory teams to align business objectives with scientific advancements., • Support the development of commercialization strategies for biotech products and innovations., • Lead and mentor a team of business development professionals to achieve company goals. Requirements • 10 year work experience;, • More than 5 years team management experience., • Manage team subordinates more than 21., • The average job tenure is 30 months., • Life-science industry, IVD preferred., • Less 7 companies, no consulting experience., • Regulatory Understanding, Familiarity with FDA, IVDR, and other relevant regulations affecting biotech and diagnostics., • Market Analysis, Ability to assess market trends, competition, and business opportunities. Benefits • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

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 Associate Director, Regulatory Operations, is responsible for strategic and operational leadership of complex submissions, publishing, and regulatory information management systems. This role ensures the delivery of high-quality, compliant regulatory dossiers. This role ensures the delivery of high-quality, compliant regulatory dossier to FDA and global health authorities. The Associate Director serves as a subject matter expert in electronic submissions (eCTD), publishing systems, and regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization. Responsibilities • Provide operational leadership and oversight for global regulatory submissions, ensuring compliance with applicable regional regulations and technical requirements. Oversee preparation, publishing, quality control, and transmission of electronic submissions (eCTD) for INDs, NDAs, CTAs, MAAs, and post-approval submissions, • Ensure submissions deliverables meet health authority formatting, validation, and technical standards, • Own and oversee regulatory publishing systems and regulatory information management systems (e.g., Veeva RIM), ensuring system integrity, compliance, and optimization., • Establish and maintain standardized processes for document formatting, publishing workflows, submission validation, and archiving., • Oversee regulatory archiving and document retention practices in accordance with global regulatory requirements., • Evaluate and implement system enhancements, automation, and emerging technologies to improve efficiency and compliance., • Develop and maintain SOPs and work instructions related to regulatory operations and publishing., • Serve as the regulatory operations expert to advise teams on submission standards, timelines for technical preparation, and health authority expectations., • Partner closely with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners/vendors to ensure clarify of submissions requirements and operational readiness., • Perform quality control checks and work with the subject matter expert to address findings, • Identify and resolve formatting, technical, and compliance issues related to publishing manners in collaboration with subject matter experts, • Bachelor's degree in life sciences, computer science, or related science discipline, • 8+ years of relevant experience in pharmaceutical, biotechnology, or life sciences industry, including leadership experience in Regulatory Affairs Operations and Publishing, • Deep expertise in electronic submission requirements (eCTD and regional variations), • Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools), • Experience preparing and publishing high-quality electronic regulatory dossiers with major health authorities, • Demonstrated understanding of regulatory systems from both business process and end-user perspectives., • Experience with regulatory information management systems (e.g., Veeva RIM)., • Knowledgeable in emerging technologies, including AI applications in regulatory operations., • Ability to serve as senior publishing SME and technical escalation point 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 The Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Department. The primary purpose of the position is to facilitate efficient clinical trial planning and execution. Responsibilities • Develop and maintain study tools and trackers (e.g., study contact lists, study vendor contract tracking, site visit report completion, sample management), • Update periodic clinical study and portfolio overview reports provided to senior management, • Route and track approval forms for essential study documents (e.g., informed consent, study plans, etc.), • Submit and track study agreements, contracts, budgets for assigned studies, • Obtain/assign investigative site identification numbers, • Request country-level clinical trial liability insurance certificates for assigned studies, • Provide Regulatory Affairs with copies of the 1572/Investigator Statement of Compliance and Financial Disclosures, • Request study set-up in Veeva Vault and system access for study team members, • Collaborate with eTMF Owner to draft and finalize the eTMF Plan and Expect Document Lists (EDLs), • Perform TMF filing, which may include reviews and reconciliation activities, • Assign and track study specific training for all Clin Ops team members based on the core curriculum, • Manage off-site document storage and retrieval as applicable, • Provide initial and ongoing study information in support of clinical trial registration (e.g., Clinical Trials.gov), • Execute ad hoc study-related administrative tasks assigned by Study Lead, • Assist in the planning and coordination of meetings including logistics, agenda preparation and distribution of meeting minutes and meeting materials, • Participate in Clinical Operations department initiatives and other duties as assigned, • Recommend modifications to SOPs/WIs when necessary to improve compliance or efficiency, • Comply with assigned SOPs/WIs and applicable plans, guidelines and standards, • In addition to Key Duties and Responsibilities:, • May perform QC (formatting, spelling, grammar, accuracy, consistency) of study related documents (ICFs, study plans, etc.) in alignment with study protocols, • May contribute to the development of study related documents (study plans, study templates, investigator site file materials, newsletters, etc.), • May function as a point of contact between clinical vendors as delegated by Study Lead, • 1 year of experience in similar industry position, • Basic understanding of Good Documentation Practice (GDP) and ICH-GCP, • Pharmaceutical or biotechnology environment experience and valued but not mandatory, • Ability to multi-task and prioritize effectively with input from manager or Study Lead, • Proficient interpersonal, verbal and written communication skills, • Ability to work effectively independently and in a collaborative team environment, • Basic software skills (MS-Outlook, Word, Excel, DocuSign), • Ability to perform Key Duties and Responsibilities in a timely manner and with minimal supervision, • 4-year college degree preferred 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. The Post-Marketing Product Quality Compliance Manager will oversee post-market product quality activities in compliance with FDA regulations and internal Quality System requirements. This role leads and develops a team responsible for product quality complaints, post-distribution quality monitoring, and the execution of quality-driven field actions, including recalls and market withdrawals. The manager provides strategic direction, coaching, and performance management to ensure timely, compliant, and effective execution of post-market quality processes while fostering a culture of quality and continuous improvement.Responsibilities * Post-Market Surveillance & Data Analysis • Manage the end-to-end product quality complaint process from intake through closure., • Assess complaints for product quality impact, GMP compliance risk, and field action triggers., • Trend and analyze post-market quality data to identify recurring or systemic issues., • Provide Quality oversight of vendors supporting complaint intake or triage., • Ensure accurate, complete, and timely complaint documentation., • Perform initial Quality assessments and ensure appropriate complaint classification., • Escalate potential adverse events to Pharmacovigilance per established procedures., • Escalate critical or high-risk quality issues in a timely manner., • Identify and assess potential recalls, market withdrawals, or corrections., • Lead quality-driven recalls, including regulatory notifications, documentation, and effectiveness checks., • Drive CAPAs resulting from post-market quality issues and verify effectiveness., • Maintain and improve SOPs related to complaints, post-market monitoring, recalls, and vendor oversight., • Oversee Internal Audit program and Inspection Readiness., • Act as a Quality SME during FDA inspections and audits., • Support preparation of inspection responses and supporting documentation related to post-market quality activities.Requirements, • Education: Bachelor’s degree in Life Sciences, Engineering, or a related field (Master’s preferred)., • Professional Experience: Minimum 7 years of experience in Quality within a regulated pharmaceutical, biologics, or cell therapy environment., • Leadership: 2 years of people management experience., • SME Knowledge: Hands-on experience with product complaints, post-market quality surveillance, and recalls or field actions., • External Oversight: Experience overseeing external vendors in a regulated Quality environment., • Regulatory Foundation: Strong knowledge of FDA Quality System and post-market requirements. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our Conjugation-Discovery Chemistry Department as a Senior Scientist I and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The Senior Scientist I will support ongoing RNA-based drug discovery projects in several therapeutic areas. Essential Responsibilities: • Design, synthesis, purification and analysis of oligonucleotide-conjugates on antibodies and other modalities. Develop and optimize conjugation protocols using novel chemistries and technologies for target drug delivery., • Evaluate SAR on the conjugates and drive the program by collaborating cross-functionally with the teams., • Track progress against project timelines, generate regular status updates, and communicate progress to the team., • Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company to advance discovery research activities to pre-clinical development., • Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience., • Manage and maintain equipment, reagents and dedicated laboratory environment needed to carry out assignments., • Maintain updated and well-organized lab notebooks and batch records., • Execute daily laboratory operations with an approach designed to minimize risks and hazard waste streams., • Maintain all appropriate corporate standards for facility safety and hazardous material management. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Ph.D. in Chemistry, or related scientific discipline, • 3-5 years bioconjugation-related industrial experience., • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • In-depth knowledge of modern bioconjugation methods on antibodies (ADC, AOC), proteins, peptides, and other biomolecules., • Hands-on experience in the analytical characterization of the conjugates with strong analytical mindset. Proficiency in purification techniques such as RP-HPLC, FPLC, SEC, and IEX., • Team management experience, • Previous experience with RNA/oligonucleotide therapeutics is preferred but not essential., • A track-record of impacting drug discovery programs through driving projects to key decision points., • Positive attitude and high personal and ethical standards. A strong team player with a passion for science and drug discovery., • Must be able to work independently as well in cross-functional team settings with supervision as needed., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead Pharmaceuticals is seeking a Director of Pharmacometrics and Clinical Pharmacology to provide strategic and scientific leadership across the company's clinical development programs. This senior-level role is responsible for advancing pharmacometric and clinical pharmacology strategies to support the global development and regulatory submission of Arrowhead's leading siRNA therapeutics. The Director will play a critical role in clinical trial design, data analysis, regulatory documentation, and cross-functional decision-making, ensuring that dosing strategies and clinical pharmacology plans are scientifically rigorous and aligned with regulatory expectations. Responsibilities • Provide leadership and subject matter expertise in pharmacometrics and clinical pharmacology across Arrowhead's development portfolio., • Contribute to global regulatory submissions, including marketing applications for siRNA-based therapeutics., • Design and support clinical trial protocols, including dose selection and optimization strategies., • Author and review clinical pharmacology sections of Investigational Brochures (IBs), Clinical Study Reports (CSRs), and other regulatory documents., • Conduct and oversee analysis of clinical and translational PK/PD data, including population PK/PD modeling., • Communicate analysis results, interpretation, and strategic recommendations to project teams in a timely and effective manner., • Develop clinical pharmacology plans and propose dosing strategies across development stages., • Doctoral degree (PhD, PharmD) in pharmacokinetics, pharmacology, pharmaceutical sciences, or a related discipline., • 8 years of post-degree experience in the pharmaceutical or biotechnology industry in pharmacometrics or clinical pharmacology roles., • Demonstrated expertise in population PK/PD modeling, with proficiency in standard software platforms such as NONMEM. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Description We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements. Job Type: Full time Job Title: Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities · Prepare and submit 510(k) applications for IVD products to ensure timely market entry. · Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory bodies, as needed. · Conduct regulatory risk assessments and develop mitigation strategies for IVD products. · Stay updated with regulatory changes and ensure all IVD products comply with current regulations. · Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions. · Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization. · Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance. · Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company’s products. Requirements · Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field. · Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions. · Strong understanding of FDA regulations, guidance documents, and processes related to IVD products. · Experience in interacting with regulatory agencies, particularly the FDA. · Excellent analytical, organizational, and communication skills. · Detail-oriented with the ability to manage multiple projects simultaneously. Preferred Skills RAC certification or similar. Benefits • Health Care Plan (Medical), • 401K, • Paid Time Off and Paid Sick Leave

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 Discovery Pharmacology Intern will support research efforts at Arrowhead Pharmaceuticals by contributing to studies focused on early CNS programs. This internship offers hands-on laboratory experience characterizing protein expression in human cell lines and analyzing experimental data to better understand biological mechanisms relevant to therapeutic development. The intern will work closely with scientists to generate and interpret data and will summarize findings in a scientific poster presented at the end of the internship. 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 experiments to characterize ATXN1 protein expression in human cell lines, including healthy and patient-derived models., • Perform cell culture and aseptic techniques under supervision., • Conduct immunoassays, including use of platforms such as JESS, as applicable, • Analyze experimental data and organize results using appropriate tools., • Maintain detailed and accurate experimental records in accordance with laboratory standards., • Summarize research findings and prepare a scientific poster and/or PowerPoint presentation., • Present project results to the research team toward the end of the internship., • Currently enrolled student at an accredited university or college, majoring in a biology-related field such as Cell Biology, Molecular Biology, Human Biology, Neuroscience, or a related discipline., • Completion of relevant coursework in biology or life sciences., • Completion of coursework in Molecular Biology, Cell Biology, Neurobiology, and/or Biotechnology, • Familiarity with protein expression analysis, immunoassays, or cell-based assays., • Interest in translational research or neuroscience-related drug discovery., • Proficiency in Microsoft Office applications. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionSalary: $68,640 - $70,000/year About BPS Bioscience: BPS Bioscience is a leading biotechnology company based in San Diego, CA, specializing in the development and production of high-quality recombinant proteins, cell lines, assay kits, and related products to accelerate life science research and drug discovery. Our mission is to empower innovation by providing cutting-edge tools and services to scientists worldwide. Job Overview: This position requires the ability to perform and independently interpret protein purification experiments. The successful candidate will be tasked with duties in biochemistry, including affinity and FPLC chromatography, SDS-PAGE, Western Blot, and spectrophotometric analysis. This position will also include data entry and general lab maintenance. Responsibilities: Perform routine, bench-scale protein purifications following standard work instructions. Perform necessary quality control experiments, including SDS-PAGE, UV/Vis Spectroscopy and Western Blot. Prepare buffers, reagents, and other materials necessary for experiments. Handles documentation needed for project validation and research quality control; keeps an updated laboratory and database record with project details and information. Ensures lab cleanliness and safety by maintaining equipment and technician attire, and keeping all samples properly labeled and stored. Maintains common lab supply stocks as needed. Performs internet searches to gather relevant information, record and present any relevant findings in a manner pursuant to facility protocol. Other duties as assigned. Requirements: Bachelor's plus 1.5 years experience, or masters degree in biological sciences or equivalent. Ability to calculate molar solutions, use a micropipette, follow written procedures precisely. Knowledge of basic protein purification principles and protein analysis techniques is preferred. Good communication, interpersonal, and teamwork skills are essential. Benefits • 401k with 4% company match, • Companywide lunches provided quarterly, • Medical/Dental/Vision health insurance plans, • Vacation and paid holidays Why Join BPS Bioscience: • Contribute to the development of cutting-edge life science tools used by researchers worldwide., • Work in a collaborative, innovative, and scientifically driven environment., • Opportunity to gain experience in both production and R&D workflows., • Competitive compensation, benefits, and opportunities for professional growth. BPS Bioscience is an equal opportunity employer, without regard to race, color, religion, age, gender, sexual orientation, disability, or any other characteristic protected by applicable law.

Job DescriptionThe Director, Global Regulatory Affairs will play a critical role in developing and implementing regulatory strategies to support the global development and expansion of Janux’s clinical pipeline. This player-coach individual will work closely with cross-functional teams to ensure compliance with regulatory requirements and to achieve successful regulatory approvals.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Develop and execute global regulatory strategies for one or more programs., • Will be the regulatory lead for project teams and sub-teams for one or more programs., • Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs, MAAs, etc.)., • Serve as the primary regulatory contact with health authorities, including the FDA, EMA, MHRA and other global regulatory agencies for assigned programs., • Provide regulatory guidance and support to cross-functional teams, including Clinical, Therapeutic Discovery, and CMC teams., • Monitor and interpret regulatory requirements and trends to ensure compliance and to inform strategic planning., • Manage regulatory timelines and ensure timely submission of regulatory documents., • Lead regulatory agency meetings and negotiations., • Own the preparation of regulatory documents, including briefing packages, responses to health authority queries, and labeling., • Ensure that all regulatory activities are conducted in accordance with applicable regulations, guidelines, and company policies., • Other duties as deemed necessary., • Travel up to 25%EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • BS degree in life sciences or a related field is required. Advanced degree in life sciences (MS, PhD, PharmD, MD, or equivalent) preferred., • Minimum of 10 years of experience in regulatory affairs within the biotechnology and biopharmaceutical industries and working knowledge of the development of biologics targeted for the treatment of cancer., • Proven track record of successful regulatory submissions and approvals, alongside successful direct interaction with global regulatory agencies (FDA, EMA MHRA and others)., • In-depth knowledge of global regulatory requirements and guidelines is required., • Strong leadership and project management skills., • Excellent written and verbal communication skills., • Ability to work effectively in a fast-paced, dynamic environment., • Strong analytical and problem-solving abilities.

Job Description About Capricor Therapeutics Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX™ platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future. About the Role We are seeking a highly skilled Formulation Scientist to join Capricor Therapeutics and drive the development of stable, lyophilized exosome-based formulations for our groundbreaking therapies. In this critical scientific role, you will lead formulation design, optimization, and characterization, ensuring compliance with cGMP and supporting IND-enabling studies. You will collaborate with cross-functional teams, including analytical sciences, process development, and regulatory affairs, to advance our novel exosome-based drug delivery platforms. This role offers a unique opportunity to shape the future of exosome therapeutics, contributing directly to Capricor’s mission to transform the biotech industry and improve lives. Responsibilities Strategic Scientific Leadership • Develop and execute innovative formulation strategies for exosome-based drug products, aligning with Capricor’s mission to deliver transformative therapies for rare diseases, including DMD., • Stay ahead of advancements in exosome, lipid nanoparticle (LNP), and lyophilization technologies, implementing cutting-edge solutions to maintain a competitive edge., • Design and optimize exosome-based formulations for therapeutic modalities (e.g., nucleic acids, proteins, biologics), ensuring stability at 4°ree;C or room temperature for enhanced shelf-life., • Lead lyophilization process development for drug substances (DS) and drug products (DP), optimizing excipients, cryoprotectants, and thermal characterization (e.g., DSC, Freeze-Dry Microscopy) to extend stability., • Develop storage buffers (e.g., LNP-based) to support flexible storage conditions (4°ree;C, room temperature, -20°ree;C) and improve DS/DP integrity., • Perform physicochemical and biophysical characterization using techniques such as DLS, TEM, HPLC, LC-MS, DSC, and fluorescence-based assays to assess formulation performance., • Develop and validate quality control (QC) methods to evaluate stability, particle size, encapsulation efficiency, and biological activity of exosome-based DS/DP., • Collaborate with analytical scientists, process engineers, and regulatory affairs teams to define critical quality attributes (CQAs) and support IND submissions., • Partner with process development to transition formulations from R&D to clinical and commercial scale, ensuring scalability and GMP compliance., • Drive advanced formulation optimization to enhance exosome stability and delivery, leveraging data-driven approaches to meet regulatory and clinical demands., • Monitor and analyze key performance indicators (KPIs) for formulation processes, implementing corrective actions to improve efficiency and reliability., • Stay current with scientific literature and industry trends, contributing to Capricor’s innovation in exosome-based therapeutics. Requirements Minimum Qualifications • Education: Ph.D. in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemical Engineering, or a related field with 4+ years of biopharmaceutical industry experience; Master’s degree with 6+ years of relevant industry experience considered., • Experience: 4+ years of hands-on experience in biologics or vesicle-based formulation (e.g., exosomes, LNPs, liposomes, mAbs, peptides) in the biopharmaceutical industry., • Lyophilization Expertise: Direct experience with lyophilization process development, including excipient selection, thermal characterization, and cycle optimization for DS/DP stability., • Stability Optimization: Proven expertise in optimizing formulation stability at 4°ree;C or room temperature through forced degradation, real-time, and accelerated stability studies., • Analytical Skills: Proficiency in analytical techniques, including HPLC, LC-MS, DLS, TEM, and DSC, for formulation characterization., • Scientific Leadership: Demonstrated ability to plan and lead initiatives as a hands-on bench scientist in a fast-paced research environment., • Regulatory Knowledge: Strong understanding of cGMP, ICH guidelines, and compliance with 21 CFR Part 1271 and cGTP for injectable formulations., • Skills: Exceptional problem-solving, attention to detail, and communication skills, with a collaborative approach to cross-functional teamwork., • Direct experience with exosome-based therapeutics or vesicle-based systems (e.g., LNPs, liposomes)., • 5+ years of industry experience in biopharmaceutical or regulated environments within GMP or QC settings., • Expertise in GMP manufacturing, scale-up, and technical transfer to CMOs., • Experience authoring CMC sections for IND submissions or supporting regulatory interactions., • Proficiency in data analysis tools (e.g., Microsoft Excel, statistical software) and familiarity with process monitoring techniques., • Strong scientific communication and technical writing skills for reports, publications, and patent filings. Location Policy This position is based in San Diego, CA, with flexibility for occasional remote work as needed. Work Environment/Physical Demands • Physical Requirements: Ability to sit and stand for extended periods, lift/carry laboratory equipment and materials up to 40 pounds, move about the lab, and communicate effectively via telephone or in person. Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry through exosome-based therapeutics, we’d love to hear from you!

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 Supplier Quality Associate is a critical role responsible for overseeing the development and maintenance of a robust supplier quality program, managing external audit programs, and ensuring compliance with Good Manufacturing Practice (GMP) standards. This position will drive supplier qualifications, conduct risk-based audits, and collaborate with cross-functional teams to maintain high-quality standards and support continuous improvement. The ideal candidate is a detail-oriented professional with extensive experience in supplier quality management and GMP/GLP environments, capable of working independently to meet project goals while ensuring regulatory compliance. This role will play a pivotal part in upholding Capricor’s commitment to quality and excellence in the development of innovative therapies.The team this person will be joining develops and maintains the Supplier Quality Program, conducts supplier qualifications and audits, manages SCAR activities, generates and manages Quality Agreements, and develops SOPs.Responsibilities • Develop and Maintain Supplier Quality Program: Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain., • Travel: Occasional travel may be required for supplier audits or vendor meetings., • Create Supplier Scorecards: Develop and maintain scorecards to evaluate supplier performance and drive accountability., • Ensure Audit Readiness: Maintain audit readiness and compliance with GMP and other regulatory standards., • Conduct Supplier Qualifications and Audits: Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality., • Manage SCAR Activities: Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues., • Collaborate on Material Specifications: Work with cross-departmental teams to develop and refine material specifications., • Prepare Quality Metrics: Compile and present quality metrics to stakeholders to support decision-making., • Address Quality Issues: Partner with internal teams to resolve supplier quality and audit-related challenges., • Drive Best Practices: Contribute to the development and implementation of best practices to enhance compliance and performance., • Perform Data Analysis: Conduct data analysis and maintain organized records, reports, and databases to support quality processes., • Implement Continuous Improvement: Recommend and implement measures to enhance quality processes and operational efficiency., • Present Data Internally: Deliver data-driven insights to support decision-making and quality initiatives., • Work Independently: Operate with minimal supervision to achieve project goals and meet deadlines., • Review and Approve Documents: Review and approve assigned documents to ensure accuracy and compliance., • Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives.Requirements, • Education: Bachelor’s degree in a relevant Biological Science discipline required., • Experience: 3 years of experience in a GMP Quality Control laboratory or GMP/GLP setting required, with direct experience in Supplier Quality Management and corporate/supplier audits., • Experience conducting audits is a plus., • Supplier/Vendor Qualification: 3+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring., • SCAR Management: Experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues., • SOP Development: Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance., • Experience facilitating Supplier Quality Agreements is a plus., • Technical Skills: Proficiency in Outlook, MS Office, and eQMS is a plus, • Communication and Teamwork: Excellent communication, time-management, and teamwork skills to collaborate effectively across departments., • Organizational Skills: Strong organizational skills and attention to detail to manage records, reports, and databases., • Multitasking: Ability to prioritize and manage multiple responsibilities in a fast-paced environment., • Work Environment Adaptability: Ability to gown and work in classified areas for audits or inspections., • Independent Work: Ability to independently perform tasks, generate reports, and escalate issues as needed., • ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe., • Strong team player with the ability to collaborate effectively across cross-functional departments. Work Environment and Physical Demands • Setting: Primarily office- and laboratory-based, focusing on supplier quality management, audits, and documentation, in an office or hybrid arrangement due to limited office space.

Job DescriptionSalary: $150,000 - $200,000/year + bonus As a subject matter expert, this role will support the execution and delivery of clinical and translational biomarker services for Sponsor and internal R&D studies. This role will function to lead and support immunostaining assay development, biomarker projects, and advanced image analysis including developing and applying AI-driven image analysis algorithms to quantitatively assess histopathology and biomarker data, while also serving as a scientific partner to clients from study design through data interpretation and presentation. The role will work cross-functionally with pathologists, laboratory technicians, scientists, project operations and business development teams, and will directly support pharmaceutical and biotechnology clients in planning, executing, and interpreting biomarker studies across preclinical and clinical programs. What you'll be doing: Lead/Support Scientific Efforts for Computational and Digital Pathology • Act as a scientific interface with clients, participating in client meetings, protocol reviews and data review meetings, • Provide expert input on design and conduct of clinical or translational studies incorporating biomarker endpoints and omics and non-omics techniques including but not limited to immunostaining, proteomics, spatial biology, computational and digital pathology., • Prepare and/or support the preparation and review of project plans, analysis plans and study reports, abstracts, manuscripts, and technical reports., • Perform and/or support the analysis and interpretation of biomarker data including providing clear, scientifically rigorous data visualizations, analyses, and summaries. Assay Development, Image Analysis, and Algorithm Development • Partner with laboratory technicians to support immunostaining assay development, optimization, and validation., • Define analytical endpoints, scoring strategies, and quality control metrics aligned with assay performance., • Contribute to assay validation documentation and analytical reports as required., • Develop, validate, and maintain image analysis pipelines for immunostaining (IHC), immunofluorescence (IF), in situ hybridization (ISH), and multiplex assays., • Design and implement AI/machine learning algorithms for tissue segmentation, cell characterization, and biomarker quantification., • Collaborate with pathologists through end-to-end workflows including assay development, validation, quantitative read-outs and interpretation., • Ensure traceability, reproducibility, and documentation of analysis workflows. Business Development Support • Assist with business development activities including participating in client meetings, requests for proposal (RFP) responses, project pricing, protocol review, and bid defenses as needed., • Provide advice to sponsors seeking guidance, • Assist in the development of sales, marketing and promotional materials as needed. Product and Service Innovation Support • Contribute to continuous improvement of computational, digital pathology, spatial biology and translational research capabilities., • Assist in the development of our product/service platforms to ensure all stakeholder requirements are being considered, documented, and translated to the final solution., • Participate in brainstorming meetings and functionality reviews. Qualifications • Post-graduate degree / professional designation; 7-9 years related experience, plus continuous training and knowledge/skills upgrading, • Strong experience with digital pathology and image analysis, • Solid understanding of histopathology and immunostaining techniques, • Experience working in CRO, laboratory, biopharma and/or regulated research environment, ideally supporting clinical and translational research studies, • Experience presenting data to external stakeholders or at scientific meetings, • Scientific rigor and attention to detail - able to communicate complex scientific concepts and results clearly to all stakeholders, • Strong written and oral English communication skills, problem-solving and analytical thinking, • Ability to manage multiple projects in fast-paced environment with a collaborative mindset across disciplines Note: Compensation is dependent on the unique experience, skills, and education the successful candidate brings to the role. The range above represents an estimated base salary that we would expect to compensate at, but we encourage applicants to speak with the member of the TA team if contacted for an initial phone screen should your expectations differ from those listed above.