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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 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 DescriptionCompany Description EVERSANA INTOUCH™ is a leading full-service, global healthcare agency serving the life sciences and pharmaceutical industries. We provide next-generation creative and media services, enterprise solutions and data analytics services for clients. We combine the power of world-class creative and digital teams with deep market access, payer, and healthcare communications expertise to provide innovative solutions to life science companies that want to connect with consumers, healthcare professionals, and payers. We get fired up when people talk about getting—and staying—healthy. That’s where we find our inspiration: in the very human experiences of patients, doctors, and even each other. Then, we collaborate on ways to make caring for one’s health more achievable, connecting patients and physicians with the information and tools they need. And as a part of EVERSANA, a pioneer in next-generation commercial services, we connect dots that other agencies can’t, helping drive commercialization success. 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 INTOUCH, our people, clients and most importantly, the patients we serve. Job Description The Senior Director, Analytics is a trusted internal strategic analytic partner managing a brand or portfolio team to deliver client delight and growth. This is a leadership role within our Marketing Analytics group. The Senior Director, Analytics works with clients, subject matter experts (SMEs) in other departments, and our Marketing Intelligence colleagues to deliver insights that inform strategy development and drive the optimization of our Omnichannel programs. Responsibilities include managing direct reports, proposing ideas, managing senior client relationships, delivering presentations, and contributing to the development of our Analytics practice. The Senior Director, Analytics must be a strong leader skilled in leveraging data-driven solutions to inform and drive Omnichannel program performance. The ideal candidate provides insights from campaigns, claims, and internal client data that can inform strategies and deliver quantified impact. The role involves leading a portfolio of client engagements, providing guidance to managers and analysts within the team, and ensuring effective measurement planning and performance analysis. The role also involves advocating for the implementation of optimization recommendations, serving as a consultative partner to clients and SME colleagues, and identifying growth opportunities to help clients address challenges. The candidate will be responsible for growing existing client relationships and supporting new business development opportunities. Success in this role is measured through client satisfaction, internal team/stakeholder satisfaction, and team billability. Qualifications ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: * Serve as lead partner and contact for Analytics on portfolio/brand engagement for team and clients * Design and lead presentations and communicate business value derived from each engagement to senior clients. * Provide oversight for data analysis and interpretation of results in business context, presenting findings and implications to key stakeholders at all levels * Understand the client’s business context and goals and how marketing activities are evaluated to support these goals. Collaborate with the client team and internal SMEs (Account Management, Planning, CX, CS, UX) to improve campaign performance and user experience. * Manage scoping and budgeting process for assigned portfolio and brands and maintain relationship with AM/PM to ensure up-to-date analytics scopes. Accountable for portfolio revenue & profit and secure scopes by developing analytics proposals including definition of deliverables, timing, costs. * Secure growth by providing thought leadership and direction. Participate in advocating for data-driven solutions through Accounts Management and Omnichannel teams. * Ensure deliverables are on time, accurate, and compelling to client/business objectives and manage internal teams’ and clients’ expectations regarding timelines * Manage projects responsibly, assigning analytics talents to appropriate tasks * Develop new methodologies and frameworks building on existing EVERSANA INTOUCH intellectual capital and partner with key external vendors and partners * Enhance data strategy and maintain expertise in omnichannel marketing, analytical tools, techniques, and similar requirements. * Coach and mentor talent, creating an environment for talent to grow, stay engaged, and perform their best * Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. * All other duties as assigned MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. * 12+ years of experience in an Analytics role * 3+ years in a Pharmaceutical Marketing Analytics role preferred. Agency experience a plus. * Compelling presentation, writing, and storytelling abilities * Advanced knowledge of omnichannel or multichannel marketing analytics with a focus on digital (e.g., Web, Email, Paid media, Social media, Organic search, Mobile apps) * Ability to manage 2 or more direct reports * Command of data analysis to justify insights or recommendations impacting a client’s brand and business goals * Proficiency with MS Office Suite * Strong analytical and problem-solving skills * Desire and ability to mentor and train employees and work collaboratively with team members * Strategic thinking to lead teams and mentor staff to achieve success across multiple accounts * Interest in self-education and staying updated on marketing analytics trends and tools * Self-directed and motivated with strengths in planning, organizing, and project management to meet deadlines, prioritization and multitasking skills * Master of written and oral communication skills * Able to set priorities for the team and manage timelines 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 hold myself accountable. Embrace Diversity I create an environment of awareness and respect. 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. Always Innovate I am bold and creative in everything I do Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

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

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

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Eurofins PSS Insourcing has an exciting and rewarding opportunity for a Business Development Manager to join our team. We are searching for a business development professional with proven experience selling and implementing high-value sales. Someone who thrives on identifying and closing new business caring for the client through the process will succeed in this role. This position offers the excitement of hunting for new clients with the goal of diversifying our offerings and client base as well as the opportunity to foster and expand partnerships with key clients. This is a hybrid role working remotely from a home office, travelling locally and within the region for prospect and current client meetings as well as full days spent at current client sites to maximize networking and relationship building opportunities. A successful candidate will have a proven track record and is comfortable reaching out to and meeting with high level decision makers including C-Suite. This position will manage the strategic sales process including identifying client needs, defining and presenting how PSS can address them, as well as managing the implementation process for new programs. If you’re looking for a rewarding career, a place to call home, apply with us today! Job Description The ideal candidate can demonstrate the following: • Strong business acumen, • Passion for closing new business, • Extensive experience and success with new client acquisition, • Proficient execution of driving and managing the entire sales development cycle from prospecting through project implementation, • Identifying and researching new sales targets and qualifying leads, • Comprehensive understanding of sales strategies and techniques, • Comfort and confidence in engaging with executive-level stakeholders, • Experience managing prospect relationships, uncovering needs, and securing opportunities to engage in meetings to present the Eurofins PSS Insourcing model, • Ability to manage complex sales cycles and collaborate cross-functionally, • Active listening skills, • Skilled and successful at developing long-term strategic relationships by partnering with clients to better understand their business objectives and needs resulting in securing substantial, complex sales, • Experience monitoring competitor activity and identifying market trends, • Developing action plans to achieve KPIs and sales goals, • Contract development and negotiation skills, • Problem solving skillsQualifications Basic Minimum Qualifications: • Bachelor's degree, • 3-5 years of consultative sales experience selling professional services preferably to or within the life sciences industry, • Proven track record of consistently meeting or exceeding sales targets, • Proficient at closing sales, • Proficient at creating, developing and maintaining client relationships, • Experience and comfort with prospecting, • Quick learner, • Willingness to travel up to 75% of the time locally, within a region, • Experience selling in the staffing, recruiting, insourcing and/or laboratory services industry, • Experience working with a CRM, • Experience leading and managing projects, • Book of business within the biopharma industry Additional Information Target compensation: $85k - $110k base • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

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 looking for a Senior Director of Pharmacovigilance with deep expertise within biotechnology, ideally in rare diseases or cell therapies. This role will play a pivotal part in building the pharmacovigilance function as we advance our lead programs following recent clinical milestones. This individual will ensure high-quality, compliant safety processes, oversee vendors and safety surveillance, and facilitate rapid communication of safety concerns. This new headcount position supports our major milestone of positive Phase 3 results and continued advancement of deramiocel.Responsibilities • Design, implement, and manage a robust, compliant, and scalable global pharmacovigilance system, including policies, procedures, and infrastructure suitable for cellular therapy products., • Develop and lead pharmacovigilance activities essential for program progression, including creation of the Risk Management Plan (RMP), Pharmacovigilance System Master File (PSMF), and required safety labeling sections., • Select, onboard, and oversee pharmacovigilance operations vendors and safety database providers to ensure high-quality case management, reporting, and regulatory compliance., • Direct and execute global safety surveillance activities, including monitoring, evaluation, and interpretation of safety data from various sources such as spontaneous reports, literature, and post-approval studies., • Lead signal detection and management processes, ensuring periodic review and updates to the RMP and PSMF., • Oversee and review aggregate safety reports (e.g., PSURs/PBRERs, DSURs) for submission to global health authorities., • Serve as the pharmacovigilance lead during health authority inspections (e.g., FDA, EMA) and internal audits., • Collaborate closely with Regulatory Affairs on submissions and labeling, with Clinical Operations/Development for seamless safety transitions, and with Commercial and Medical Affairs teams to provide expertise and training on safety reporting., • Chair and lead the internal Safety Review Team (SRT) for ongoing evaluation of product benefit-risk profiles., • Interface with vendors such as PPD and Syneos, clinical trial teams, CMO, and commercial partners to prepare safety documentation and oversee post-marketing clinical safety surveillance., • Work cross-functionally to drive business impact, team success, and continuous improvement in pharmacovigilance operations., • Monitor emerging safety data, regulatory trends, and therapeutic advancements in rare diseases and biologics to inform strategy., • Perform such other duties as may be assigned from time to time.Requirements, • Bachelor's degree in a health science field (MD, PharmD, PhD, or equivalent preferred)., • Minimum of 8+ years of progressive experience in Pharmacovigilance/Drug Safety within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or management role., • Mandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU markets., • Deep understanding of global PV regulations, guidelines, and ICH standards (e.g., FDA, EMA, MHRA, and other major health authority requirements)., • Proven experience in establishing or significantly contributing to the implementation of a validated safety database and PV quality management system., • Exceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholders., • Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines., • Ability to work independently, multi-task, and meet aggressive deadlines in a fast-paced, resource-constrained environment., • Willingness to travel up to 20-30% for inspections, meetings, and collaborations., • Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)., • Equivalent combination of education and experience may be considered.Preferred Qualifications, • Experience with cellular or gene therapy products, or other complex biologics/rare diseases., • Ability to transition between strategic planning and hands-on operational execution in a small biotech environment., • Demonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory compliance.Work Environment & Physical Demands, • Professional office environment (San Diego, CA) or remote work setup with standard business hours, subject to flexibility for global interactions., • Ability to sit for extended periods during virtual or in-person meetings and computer work. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Provide strategic leadership for the design, implementation, and continuous improvement of the company's data integrity program across GxP operations supporting clinical and commercial pharmaceutical and combination products. Define and oversee company-wide governance frameworks, policies, and requirements to ensure alignment with global data integrity regulations and ALCOA++ principles. Serve as a cross-functional leader and subject matter expert, partnering across the organization to embed data integrity principles and compliance into systems, processes, and culture. Responsibilities • Lead the development, implementation, and continuous improvement of data integrity policies, procedures, and program elements in alignment with global regulatory requirements., • Establish and oversee data integrity governance programs, partnering cross-functionally to drive strategic initiatives and foster a culture of data integrity., • Develop and maintain systems for data integrity impact assessments, risk evaluations, and remediation plans, ensuring timely completion of commitments., • Evaluate data management, documentation, and record control practices across systems and formats to ensure compliance with data integrity requirements., • Implement and maintain processes to assess computerized systems, software, and equipment for compliance with 21 CFR Part 11, Annex 11, and related guidance., • Lead and oversee comprehensive data integrity audits and assessments to identify risks, gaps, or discrepancies, and lead mitigation and remediation activities., • Drive corrective and preventive actions and process improvement initiatives to strengthen data integrity controls and system reliability., • Develop, analyze, and report data integrity metrics and key performance indicators to senior leadership., • Design and deliver training programs to promote data integrity awareness and ensure consistent understanding across the organization., • Provide subject matter expertise and support during regulatory inspections and partner audits, articulating data integrity program elements and strategy., • Monitor global regulations, emerging guidance, and best practices through active engagement with relevant professional organizations (e.g., ISPE, PDA)., • Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline., • Minimum of ten (10) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including at least five (5) years in a leadership role with increasing responsibility., • Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards., • Demonstrated expertise with ALCOA++ principles, data lifecycle management, and data governance frameworks., • Proven experience applying 21 CFR Part 11, Annex 11, and other relevant regulations and guidance governing data integrity and information security., • Strong understanding of information technology and data management systems, including system validation, security, and enterprise data governance., • Proven ability to lead complex, cross-functional projects and build effective partnerships to advance data integrity and compliance objectives, demonstrating strong organizational, planning, and prioritization skills., • Strategic thinker with demonstrated success in driving continuous improvement, innovation, and proactive risk management., • Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels., • Advanced degree preferred., • Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent). California pay range $180,000—$210,000 USDCalifornia pay range $180,000—$210,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Who we are: Biosero, Inc. is the leader in life science robotic automation and integration. Our award-winning no-code software tools enable vital research to be done quickly while freeing scientists to address additional scientific challenges. Our solutions are placed in the top accounts worldwide, including the top: pharmaceutical, agricultural, clinical, diagnostics, and biotech companies. Our work impacts the world by accelerating productivity, discovery & cures. Our team is passionate about our mission to enable discoveries in life science by coupling our software platforms with data and robotics. Biosero is the fastest-growing software company in the life sciences space. We have been voted the best place to work for many years. Biosero is part of the BICO Group. BICO is the leading bio convergence company in the world, equipping hundreds of laboratories and thousands of scientists with cutting-edge life science technologies. By combining different technologies, such as robotics, artificial intelligence, computer science, and 3D bioprinting with biology, BICO enables customers to improve people's health and lives for the better. Biosero is seeking an accomplished and visionary Head of Strategy & Product Management to define and drive the company’s long-term strategic direction while translating it into actionable product roadmaps. This executive will lead the product management function, shape the overall portfolio, and ensure alignment with market needs and customer value. As a key member of the Biosero leadership team, the Head of Strategy & Product Management will also serve as an external ambassador, representing the company at industry events, customer forums, and partner engagements. Responsibilities: Strategic Leadership • Define and continuously refine Biosero’s overall business and product strategy in alignment with corporate objectives., • Partner with the Managing Director and leadership team to identify and execute growth opportunities, both organic and inorganic., • Own the end-to-end product management function, including vision, roadmap, and lifecycle management., • Translate strategic goals into prioritized development initiatives, balancing innovation, customer requirements, and commercial impact., • Collaborate closely with R&D, software engineering, and operations to ensure timely delivery of roadmap milestones., • Partner with commercial teams to gather customer insights and translate feedback into product enhancements., • Aligning with finance and operations to ensure product decisions are financially sound and operationally scalable., • Represent Biosero at key industry events, scientific conferences, and customer advisory boards., • Act as a thought leader in automation software and digital transformation within life sciences., • 12+ years of experience in strategy, product management, or general management, ideally within life sciences, automation, or laboratory software industries., • Proven success in developing corporate strategies and building product roadmaps that drive growth., • Demonstrated leadership experience in building and managing high-performing product teams., • Strong analytical, problem-solving, and communication skills., • Ability to balance visionary thinking with disciplined execution., • Strategic thinker with strong business acumen., • Customer-centric mindset with a deep appreciation for the scientific community., • Collaborative leader who thrives in cross-functional environments., • Confident communicator and public speaker. Biosero & BICO US is an Equal Employment Opportunity Employer. We are committed to a policy of equal employment opportunity for all job applicants and employees. We strictly prohibit discrimination and harassment of any kind based on the following legally protected characteristics, as well as any other characteristic protected by federal, state, or local laws: Race, color, and national origin, Religion, Sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity, and gender expression, Age, Physical and mental disability, Marital status, Status as a protected veteran or military service, Genetic information, Any other protected status under federal, state, or local law. All employment decisions at Biosero & BICO US are based on individual merit, qualifications, and business needs. We are dedicated to providing an inclusive and equitable workplace where all employees and applicants have the opportunity to succeed. Biosero provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. In addition, Biosero complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Biosero is committed to diversity and inclusion. We seek individuals from all backgrounds and appreciate and celebrate the diversity of our growing team. Powered by JazzHR Xcq85NJP5s

Job DescriptionSalary: $200k-$250k/year About BPS Bioscience BPS Bioscience advances scientific discovery by enabling researchers with innovative, reliable tools and services. Our expertise spans protein design, expression, and purification; cell line and lentiviral engineering; and biochemical and cell-based assay development. With a portfolio of 4,000+ products and rapidly growing service capabilities, we support research in immunotherapy, epigenetics, cell signaling, adoptive cell therapies, and beyond. Our customers include leading pharmaceutical companies, emerging biotechs, and top-tier academic research institutions worldwide. Position Overview We are seeking an experienced and visionary Vice President of Business Development, Services & Partnerships to lead strategic growth initiatives with biotech and pharmaceutical partners. This role will focus on expanding our service businessincluding custom cell line engineering, assay development, screening services, protein modification, and recombinant protein/antibody productionand building high-value collaborations that accelerate drug discovery. This is a senior leadership role for a strategic thinker who can both open doors and close deals. Responsibilities • Develop and execute the strategic business development plan for BPSs service portfolio., • Identify, cultivate, and close new partnerships, collaborations, licensing agreements, and long-term service contracts., • Lead discussions and negotiations at the executive level with biotech and pharma partners., • Establish alliances that expand BPSs access to new technologies, markets, or customer segments., • Collaborate closely with internal stakeholders across R&D, Operations, Sales, and Marketing to ensure commercial alignment and successful project execution., • Develop pricing, positioning, and go-to-market strategies for new service offerings., • Represent BPS Bioscience at industry conferences, partner meetings, and on-site customer visits., • Build and maintain strong, lasting relationships with decision-makers across the life sciences ecosystem., • Mentor the business development and services teams, fostering a high-performance, customer-focused culture., • Establish performance metrics, forecasting processes, and reporting systems to track progress against goals., • Provide progress updates towards goals, critical needs, and access to ongoing sales pipeline activity, proposals and contracts, • Other duties as assigned Requirements • Ph.D. in Cell Biology, Immunology, Molecular Biology, Biochemistry, or related field required., • MBA preferred but not required., • 10+ years of business development experience in biotech, pharma, research tools, CRO/CDMO, or related service organizations., • Demonstrated ability to structure, negotiate, and close multi-million-dollar agreements., • Deep understanding of early drug discovery workflows, research reagent markets, and/or CRO/CDAO partnership models., • Strong leadership presence with exceptional communication, negotiation, and relationship-building skills. Benefits! • 401k with company match, • Medical/Dental/Vision health insurance plans, • Vacation and paid holidays Why Join BPS Bioscience? • Help shape the growth of a recognized leader in first-to-market reagent innovation., • Work with cutting-edge technologies and world-class scientific teams., • Lead partnerships that impact major therapeutic areas, including oncology, autoimmune disease, metabolic disease, and neuroscience., • Competitive compensation package, including base salary, performance incentives, and full benefits 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 DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring an experienced Validation Engineer to support equipment, process, software, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP, Annex 11, and global regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance. • Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems., • Generate and execute validation documentation for manufacturing equipment, utilities, and computerized systems in accordance with cGMP, GxP, and Annex 11 requirements., • Support CQV activities for sterile injectable manufacturing equipment and site utilities, ensuring seamless integration and qualification., • Lead CSV efforts, including risk assessments, validation plans, and test scripts for computerized systems to maintain data integrity., • Validate and qualify various equipment and utilities i.e Depyrogenation Ovens, • Troubleshoot and resolve issues related to validated equipment, processes, and systems; implement CAPA as needed., • Maintain accurate validation documentation and ensure audit readiness., • Additional responsibilities as assigned to drive project success. Requirements • Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences., • 4–5 years of validation experience within pharmaceutical, biotech, or medical device industries., • Strong knowledge of CSV and CQV principles, including regulatory expectations for sterile injectable manufacturing., • Familiarity with Annex 11, data integrity requirements, and industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations., • Experience with equipment, cleanroom systems, HVAC, purified water, compressed air, and other critical utilities., • Proficiency in writing and executing IQ/OQ/PQ protocols, validation reports, and computerized system validation documentation., • Strong analytical and problem-solving skills., • Excellent written and verbal communication abilities., • Strong time management and organizational skills., • Detail-oriented mindset with a commitment to maintaining high-quality standards., • Must be authorized to work in the US., • No C2C at this time. BenefitsW2 Temp positions include our medical and sick time benefits Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 to $125,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

Job Description Duties: • Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release, specifically droplet digital PCR, HPLC, ELISA, culture of primary mammalian cells, and cell based potency assays., • Participate in developing timelines, protocols and reports for assay transfers, qualifications / validations., • Author and review QC analytical SOPs, protocols, and reports as needed, • Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports, • Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS Qualifications: • BS or equivalent in relevant discipline with a minimum of 4 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 1 year of relevant industry experience, • Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role, • Experience with JMP statistical software a plus. Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval Pay Scale: $112,000 - $117,000 (Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r\n\r\nThe cornerstone of our success: a knowledgeable and experienced recruiting team.\r\n\r\nOur life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The HR Coordinator at Capricor Therapeutics will serve as the central point of contact for the employee lifecycle, supporting recruitment coordination, onboarding, record maintenance, and compliance efforts in a fast-growing biotech environment. By ensuring accurate documentation, seamless coordination of HR processes, and responsive support to employees and managers, this role plays a vital part in strengthening people operations, fostering a positive and inclusive workplace culture, and enabling the company’s mission-driven growth as we advance our pipeline toward potential approvals and commercialization.Responsibilities • Serve as the primary point of contact for routine HR inquiries, including holiday calendars, employment verification requests, org charts, policy guidance, benefits navigation, and general HR process support., • Coordinate interview scheduling, candidate communications, reference checks, background checks, and pre-employment requirements in collaboration with recruiters and hiring managers., • Assist with new hire onboarding and orientation activities, ensuring timely and accurate completion of documentation (e.g., I-9, E-Verify, compliance forms, offer letters, and system setups)., • Maintain and audit employee personnel files (digital and physical) to ensure accuracy, confidentiality, completeness, and compliance with company policies and regulations., • Support HRIS updates, payroll-related inputs (e.g., PTO tracking, corrections, bonus spreadsheets), and processing of employee status changes (e.g., promotions, transfers, terminations)., • Prepare HR documents, employee communications, reports, meeting materials, tracking logs, and other administrative support as needed., • Assist with benefits administration tasks, including open enrollment preparation, form tracking, and addressing routine employee benefit questions., • Support performance review and training cycles by tracking deadlines, preparing materials, coordinating sessions, and maintaining related records., • Help maintain compliance with employment regulations, including labor law postings, mandatory training records, EEO data collection/reporting, and policy updates (with emphasis on California-specific requirements)., • Coordinate HR meetings, employee events, culture-building initiatives, and company-wide communications to enhance engagement and morale., • Perform other HR duties and special projects as assigned from time to time.Requirements, • Bachelor’s degree in Human Resources, Business Administration, or a related field preferred., • 1–3 years of HR support experience (e.g., HR Coordinator, HR Assistant, or similar role) in a professional environment; biotech, pharmaceutical, or life sciences industry experience a plus., • Strong organizational skills, meticulous attention to detail, and proven ability to manage multiple priorities and deadlines in a dynamic, fast-paced setting., • Excellent verbal and written communication skills with a customer-service oriented mindset and professionalism in all interactions., • High level of integrity with the ability to maintain strict confidentiality and handle sensitive information with discretion., • Familiarity with HRIS (e.g., ADP, Workday) and ATS systems preferred., • Basic knowledge of employment regulations and best practices; experience with California HR compliance (e.g., wage/hour laws, paid sick leave) a plus., • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) for document preparation, data tracking, and reporting., • Ability to handle occasional extended hours depending on departmental needs (e.g., during peak hiring, open enrollment, or events).Work Environment / Physical Demands, • Primarily office-based with tasks involving HR documentation, system updates, employee interactions, and coordination activities., • Requires prolonged periods of computer use for data entry, document preparation, email communication, and HR system management., • May involve occasional lifting of office materials up to 15 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description 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 Description Work 100% remotely, set your own schedule, and earn additional income while making a real difference in men's health and lives. Hone is one of the fastest-growing health companies in the United States, and we are looking for physicians who have deep knowledge and experience in prescribing for men with hypogonadism. If you are a physician with a strong background in treating hypogonadism and experience prescribing testosterone and other hormone-optimizing pharmaceuticals, this is an opportunity to join a mission-driven team that is reshaping access to care. We treat patients with a combination of pharmaceutical products in accordance with AUA-defined protocols, supplements, and lifestyle changes. We are committed to making care more convenient and affordable for patients. Experience with weight-loss and thyroid medications is a plus, as we have expanded beyond men's hormones into these treatment areas. We have also launched services for women. Experience with women's hormone therapy allows you to see our female patients as well, but is certainly not required. We are looking nationwide and value physicians licensed in multiple states. Who We Are We're a modern health company with a simple mission: help our patients take control of their health and age with confidence. Our platform removes barriers to care through education, technology, and convenience. Our primary focus is hormone optimization for men. We are looking to add to our growing team of 150+ physicians who specialize in treating hormones and are passionate about improving patient outcomes through telemedicine. You'll join a supportive, innovative environment where you'll receive full training on our proprietary telemedicine platform, HIPAA-compliant technology, and technical support. What You'll Do • Conduct video-based consultations from anywhere with an internet connection, • Review labs and create personalized treatment plans, • Prescribe and titrate medications based on clinical findings, • Educate patients on safe and effective hormone optimization, • Provide feedback to help us continuously enhance the patient experienceWhat We're Looking For, • MD or DO with an active license (multi-state licenses preferred), • Minimum 2 years of experience in Endocrinology, Urology, Family Medicine, or Hormone Therapy, • DEA license with authority to prescribe Schedule III medications, • Strong communication skills and a passion for patient-centered care, • Comfort with technology and willingness to learn telemedicine workflows, • Availability for at least 8 hours per week, • A prescribing philosophy that values holistic care and hormone optimization, not just prescribing testosterone to everyone Help men regain their health and confidence - from anywhere. If you are passionate about hormone health, thrive in innovative environments, and want to help men live their best lives, we would love to hear from you.

Job DescriptionLitigation Attorney – Product Liability (Associate or Of Counsel) Direct Counsel is seeking a litigation attorney to join a leading national firm with openings at both the mid-level associate and of counsel levels. Locations: Atlanta, Austin, Baltimore, Boston, Chicago, Dallas, Houston, Los Angeles, Miami, Minneapolis, New York, Northfield, Palo Alto, Philadelphia, Phoenix, Raleigh, Reston, San Diego, San Francisco, Seattle, Short Hills, Washington, Wilmington About the Role The firm is looking for attorneys with strong legal writing skills and substantial experience in pharmaceutical and medical device product liability matters, particularly involving Daubert and Rule 702 motions practice. Candidates should have a background in complex litigation and be comfortable handling a range of responsibilities, including: * Drafting and reviewing motions, briefs, memoranda, and discovery responses * Developing case strategy and working with experts * Assisting with fact development and depositions * Communicating with clients and supervising junior attorneys Experience Levels Mid-Level Associate * 3–5+ years of litigation experience, ideally from an Am Law 100 firm * Demonstrated experience with Rule 702 and Daubert issues * Product liability and pharmaceutical/medical device experience preferred Of Counsel * 8+ years of litigation experience, preferably in an Am Law 100 environment * Extensive brief writing experience on Daubert and Rule 702 motions * Background in products liability litigation required; pharma/medical device is a plus Qualifications * JD from a nationally recognized law school * Admission to practice in the jurisdiction of the office location * Strong analytical, writing, and organizational skills * Ability to manage multiple priorities and work collaboratively or independently Compensation * Associate range: $250,000–$370,000, depending on location and experience * Of Counsel range: $400,000–$500,000, depending on location and experience * Comprehensive benefits package, including medical/dental/vision and 401(k) Work Environment Hybrid schedule with regular in-office presence and flexibility for remote work.

Job DescriptionLife Sciences & Technology Transactions Associate Location: San Diego, CA (Hybrid) Employment Type: Full-Time A global law firm is seeking a 3rd–5th year associate to join its Life Sciences & Technology Transactions Practice in San Diego. This role offers the opportunity to work with startups, growth-stage companies, and global enterprises on complex transactions, licensing, strategic alliances, joint ventures, collaborations, and IP-related matters in the life sciences and technology sectors. Requirements * J.D. from an ABA-accredited law school and active bar membership * B.S./M.S./Pharm.D or equivalent in life sciences, biomedical engineering, or related fields * 3–5 years of relevant experience at a law firm or in-house legal department * Strong knowledge of IP and commercial contract law, particularly in life sciences, biotech, neurotechnology, digital health, and AI * Familiarity with FDA regulations, Bayh-Dole Act, and GDPR * Strong drafting, negotiation, and communication skills * Ability to manage multiple client demands in a fast-paced environment Preferred * Ph.D./M.D. or M.B.A. in relevant field * Experience with cross-border transactions, international licensing, M&A, and IP due diligence * Industry experience at pharmaceutical, biotech, or medical device companies * Knowledge of AI/ML applications in life sciences Responsibilities * Draft, review, and negotiate licensing and commercial agreements * Advise on IP matters for corporate partnerships, collaborations, and joint ventures * Support M&A, financing, and due diligence transactions * Work closely with clients across the life sciences, neurotechnology, space, and AI sectors Compensation * $260,000–$355,000 per year, depending on experience

Job Description Job Summary: The Regulatory Manager will support and execute the planning, preparation, and submission of regulatory documents to global health authorities. In this role, you will support regulatory project planning, timelines, communications, and ensure successful regulatory submissions and deliverables on time. You will help maintain the internal systems and processes that enable efficient regulatory execution. This position is ideal for someone who thrives in a fast-paced, collaborative biotech environment and wants to contribute directly to bringing innovative therapies to patients. Key Responsibilities: • Manage submission timelines and coordinate document deadlines across Regulatory, Clinical, CMC, Nonclinical, and Quality functions, • Prepare, review, format, and publish high quality regulatory documents (e.g., IND/CTA, amendments, DSURs, meeting packages, eCTD modules) for FDA and other global regulatory agencies, • Manage project communication and stakeholder expectations, providing transparent status updates and risk identification, • Experience or familiarity with eCTD publishing systems and document management platforms (e.g., Veeva Vault, Egnyte, SharePoint), • Conduct technical quality checks, bookmarking, hyperlinking, and ensuring compliance with eCTD and regional requirements, • Maintain submission archives and lifecycle management in accordance with regulatory guidance and internal SOPs, • Track agency correspondence and commitments; assist in preparing responses to health authority requests, • Support development and continuous improvement of regulatory processes, templates, and standards, • Assist with regulatory intelligence monitoring, • Support regulatory authority interactions, • Bachelor's or higher degree in a scientific discipline, • Minimum of 5 years of experience in regulatory operations, regulatory affairs, or eCTD publishing within the biotech/pharmaceutical industry, • Strong attention to detail, organizational skills, and ability to manage multiple tasks under tight timelines, • Excellent written and verbal communication and interpersonal skills, • Experience in a small or early-stage biotech environment, • Strong knowledge of global investigational submission standards and processes (eCTD, FDA/EMA requirements, ICH guidelines), • Familiarity with regulatory publishing tools (e.g., Lorenz DocuBridge, Veeva RIM, GlobalSubmit, eCTDmanager) and document management systems We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $138,000- $148,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including: • 90% employer-covered benefits, • Flexible PTO, • A very generous holiday schedule that includes a week off in August and time off around the winter holidays, • A well-stocked kitchen with snacks and beverages, • Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match., • The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Job Description ACROBiosystems is a worldwide leader in developing and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone company in the life science and healthcare industry. We value the fast growth in a global market over a challenging time by excelling through quality, performance, and innovation, empowering our employees with trust, value, and respect, embracing diversity, and encouraging cross-functional collaboration and continuous learning. Job Summary The Regional Marketing Manager will develop, execute, and monitor local marketing strategies across the US region with a focus on local event strategies to optimize marketing event activities and raise company awareness, managing offline events throughout the entire of their life cycle. The manager must be able to gain a thorough understanding of our products and services, work with a multitude of stakeholders and represent ACROBiosystems in a professional manner while positively shaping the ACROBiosystems’ identity, profile, and visibility within the life science community. This position must also be able to work the occasional night and/or weekend, to provide on-site events and internal team support. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. • Develop local marketing plans to optimize marketing event ROI and raise company awareness., • Build offline and online event strategies to optimize marketing event activation and raise company awareness., • Develop localized promotional materials and campaigns tailored to regional regulations and cultural nuances with the internal team., • Collaborate with the digital marketing team on social media promotion, webinars, and newsletter optimization. Track and analyze the results to enhance engagement with local customers and optimize local strategies., • Coordinate related logistics related to trade shows/events; connect with different vendors and carriers to ensure the events run smoothly., • Create detailed reports and engaging presentations to effectively communicate findings and insights to internal stakeholders. This includes synthesizing complex data into clear, actionable recommendations that support organizational objectives., • Conduct thorough research about customer behavior and preferences, including interviewing, surveying, and focus groups, to analyze customer data that can enhance marketing initiatives., • Continuously monitor competitor activities and performance metrics to assess market positioning and identify competitive advantages. This involves analyzing their strategies, product offerings, and marketing efforts to inform our own strategic planning., • Supervise and mentor the offline event marketing team and foster a collaborative environment., • Manage distributors, collaborators, and partners in the US., • Master’s degree in life science or related discipline required., • Advanced degree or MBA preferred., • 5+ years of B2B or B2C marketing experience in the biotechnology or pharmaceutical industry., • Passionate about the life sciences and pharmaceutical industry and aligned with company values., • Excellent written, communication, and presentation skills., • Proficiency in marketing solutions and applications such as Salesforce, Adobe, Canva and Constant Contact, or other similar tools; as well as Microsoft Office especially Excel and PowerPoint., • Strong leadership, stress resistance, with an innovation mindset., • Strong analytical, critical thinking, and problem-solving skills, • Ability to develop strategic vision and execute resulting plans., • Multi-tasking and time-management skills, with the ability to prioritize tasks and meet deadlines., • Project management experience with the ability to coordinate multiple stakeholders globally., • Willing to travel to marketing events and activities across the US.Salary: $90,000-$120,000 base salary + bonus DOE Location: San Diego, CA or San Jose, CA (Hybrid) Work Environment & Physical Demands Office While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Job DescriptionThe Vice President, Clinical Development will serve as the strategic clinical lead for one or more of Janux’s IND programs and/or ongoing clinical trials in solid tumors or hematologic malignancies. The ideal candidate will demonstrate a proven track record of success in clinical trial leadership within academic, biotechnology, and/or pharmaceutical industries, with a strong emphasis on developing and executing clinical strategy, interpreting clinical data, and fostering productive relationships with industry KOLs, medical experts, and investigators. While experience in medical monitoring is important, the primary focus of this role is on strategic oversight and leadership of clinical development programs.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: • Provide strategic oversight and direction for one or more clinical trial programs, ensuring alignment with organizational goals and regulatory requirements, • Lead the design, development, and implementation of clinical trial strategies and plans in partnership with Pre-clinical R&D, Clinical Operations, Regulatory Affairs, Quality Assurance, and Janux’s Management Committee, • Oversee the execution of clinical development programs, including protocol development, data interpretation, and decision-making at key program milestones, • Serve as a source of medical expertise and provide high-level guidance to cross-functional teams, clinical project staff, and investigative sites, • Perform the duties of a Medical Monitor as needed to ensure clinical integrity and patient safety, while delegating operational aspects where appropriate, • Provide subject matter expertise and medical review and/or input within the preparation of medical components of clinical trial and regulatory documents which may include, but is not limited to the following: Clinical Development Plans, Clinical Study Reports, Investigator Brochures, SAE Narratives, INDs, and/or Annual Reports, etc., • Contribute to CRO, clinical site and investigator training; actively interact with CROs, clinical sites and investigators regarding study implementation, • Respond to clinical questions from sites, IRBs/IECs, Health Authorities and CROs, • Review, interpret and present clinical data to both internal and external key stakeholders, • Establish and maintain relationships with KOL’s, medical experts and investigators in the area of Immuno-Oncology and more importantly, within the genitourinary disease areas, • Other duties as deemed essentialEDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • MD or DO with a subspeciality in Oncology, more specifically in the treatment of genitourinary cancers is required, • Successful completion of post-graduate training or residency in Oncology, along with board certification or board eligibility is highly desirable, • Minimum 8 years of experience within biotechnology, pharmaceutical or relevant academic institutions required, • Expert level understanding of early drug development and clinical trial processes with a track record of leading clinical development programs is essential, • Knowledge of GCP and ICH guidelines and regulatory requirements for the conduct of Oncology clinical trials, particularly in the treatment of prostate cancer, • Strong ability to critically evaluate data, literature, and presentations Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job 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. Position Summary The Clinical Logistics Manager will oversee the end-to-end management of investigational product (IP) and non-IP clinical drug supply forArtivasAlloNK,off-the-shelf (allogeneic) cell therapy clinical programs. This individual will play a key role in ensuringtimelyand compliant delivery of clinical materials to global trial sites, managinglogisticsvendors, andmaintainingrobust site communication. The role requires close collaboration with Clinical Operations, Quality, CMC, Regulatory Affairs,MaterialsManagementand external partners to support the successful execution of cell therapy clinical trials. Key Responsibilities Clinical Supply & Logistics Management • Manage the full lifecycle of investigational product (IP) and non-IP materials, including forecasting, labeling, packaging, distribution, and returns/reconciliation., • Manage inventory of IP and non-IP materials both internally and externally, • Ensure compliance withGxP, IATA, and country-specific regulations governing cell and gene therapylogistics., • Oversee temperature-controlled shipments and chain-of-custody documentation to ensure product integrity., • Serve as the primarylogisticscontact for clinical sitesregardingproduct availability, shipment tracking, and issue resolution., • Provide training and guidance to clinical sites on handling, storage, and return of IP/non-IP materialsas needed., • Manage relationships and performance of third-partylogistics(3PL), packaging, and labeling vendors., • Support vendor qualification, audits, and oversight in collaboration with Quality and Procurementas needed., • Work closely with Manufacturing teamsand Materials Managementto align supply chain activities with production schedules., • Partner with Clinical Operations to ensure seamless coordination between supplylogisticsand trial execution., • Develop and implement process improvements for inventory management, forecasting, and sitelogisticscoordination., • Contribute to the design of digital tools or dashboards for real-time tracking of shipments and inventory. Qualifications and Experience • Bachelors degree in Life Sciences, Supply Chain Management, Pharmacy, or related fieldrequired; advanced degree preferred., • 5+ years of experience in clinical supply chain,logistics, or clinical operations within the biotech or pharmaceutical industry., • Experience managing IP/non-IPlogisticsfor advanced therapy medicinal products (ATMPs) or biologics preferred., • Proventrack recordof vendor management and oversight of global supply chains., • Strong understanding ofGxP, IATA, GDP, and cold-chain management principles., • Excellent project management and organizational skills., • Strong communicationand stakeholder management abilities across cross-functional teams and clinical sites., • Detail-oriented with the ability to troubleshoot and resolve logistical challenges under tight timelines., • Experiencewith clinical supply management systems (IRT/RTSM, ERP, or equivalent). 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: A beautiful facility An entrepreneurial, highly collaborative, and innovative environment Comprehensive benefits, including: • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $115,000 - $130,000. Exact compensation may vary based on skills and experience.

Job DescriptionTo support our growth, Janux Therapeutics is searching for a Senior Manager of Data Management to manage day-to-day operations of data management activities. The Senior Manager will ensure compliance with regulatory requirements and industry standards to improve operational efficiency. They will also manage activities with vendors to support our oncology clinical trials and maintain high quality data management deliverables in a timely manner.This role needs a proactive, and resourceful professional who has strong experience in hands-on data management activities within oncology indications.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: • Develop and oversee project level data management strategy., • Oversee CRO data management activities that support clinical trials., • Provide expertise to clinical development functions in data capture, handling, and data management processes., • In-study management for data management activities for Janux clinical studies, including coordinating tasks and deliverables across multiple clinical trials., • Evaluate Electronic Data Capture (EDC) and eSource data capture (ePRO) for implementation., • Contribute toward the drafting and implementation of Data Management Standard Operating Procedures (SOP) in collaboration with cross functional teams per regulatory requirements (ICH/GCP/CFR) and uphold industry standards in vendor outputs (SDTM/CDISC and CDASH)., • Act as primary Data Management contact for assigned projects to cross functional teams., • Review clinical documents (eg. Protocols, Case Report Forms, Statistical analysis outputs, and clinical study report)., • Review and/or develop all core Data Management Documents, including but not limited to Data Management Plans, eCRF Specifications, Data Validation Specifications, CRF Completion Guidelines, Data Transfer Agreement(s) (DTAs), Data Review Plans, and Data Integration Specifications for clinical studies., • Assist in and/or oversee external data reconciliations (SAE, central labs, etc.)., • Oversee and approve the User Acceptance Testing (UAT) of EDC, including relevant documents as needed due to protocol amendments or study needs., • Ensure clinical data within EDC is of high quality for statistical review, interim review, and/or final database lock. Coordinate data reviews between cross functional teams at Janux., • Manage projects assuring timeline and budgetary compliance in data management., • Participates in the preparation and presentation of data, when applicable. Represent Data Management in Sponsor/Regulatory Agency assessments and/or audits., • Up to 20% travel may be required based upon business needs., • Perform other tasks as necessary.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Bachelor’s degree required, advanced degree preferred. A degree in Biomedical or Life Sciences is preferred., • 6+ years of Data Management in pharmaceutical, biotech, and/or CRO, including 3 years of Management experience, including vendor oversight., • Advanced knowledge of data management process for clinical trials and the applicable regulations, experience in oncology and early phase studies required., • Ability to coordinate and drive delivery of activities of outside Data Management vendors., • Knowledge of and experience with EDC databases (especially Medidata Rave) integrations between EDC and IRT systems, CDASH/SDTM standards, medical terminology, medical coding dictionaries, data reconciliations, and quality control processes., • Knowledge and understanding of GCP, ICH and FDA requirements as applicable for Clinical Data Management (CDM)., • Ability to manage multiple initiatives and shift priorities within a small biotech environment., • Excellent interpersonal skills, strong verbal and written communication skills with the ability to work independently and collaboratively in a dynamic team environment.In addition to a competitive base salary ranging from $168,000 to $175,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Job Description: We are seeking an experienced, collaborative, and strategic physician leader with deep expertise in obesity and metabolic disease clinical development to help build and execute the clinical vision for the Company’s portfolio. This role will be responsible for defining and driving clinical strategies across early- and late-stage development programs, with a particular focus on obesity, cardiometabolic, and related metabolic indications. The Senior Director, Clinical Development (MD) will play a critical leadership role in advancing innovative therapies through the clinic, combining scientific rigor, regulatory insight, and operational excellence. The ideal candidate brings a strong track record of leading obesity and metabolic clinical trials, working cross-functionally, and delivering high-quality clinical outcomes in a fast-paced biotech environment. Essential Responsibilities: Clinical Strategy & Leadership • Lead the development and execution of clinical development strategies for obesity and metabolic disease programs across multiple stages of development., • Provide medical and scientific leadership for clinical trial design, execution, and interpretation, including endpoint selection, patient populations, safety monitoring, and benefit–risk assessments., • Serve as the primary medical expert for obesity/metabolic programs, advising internal teams, investigators, consultants, business development partners, and investors., • Champion clinical excellence and accountability across all assigned programs., • Define clinical priorities and oversee the development of protocols, amendments, and integrated development plans tailored to obesity and metabolic indications., • Ensure delivery of high-quality clinical study outputs on time and within budget., • Act as the primary medical point of contact for regulatory agencies for assigned programs., • Partner closely with Regulatory Affairs, Clinical Operations, Program Management, CMC, and other functions to ensure alignment and execution., • Lead preparation, review, and contribution to key regulatory documents, including IND submissions, investigator brochures, clinical study reports, and regulatory briefing packages., • Participate in and support FDA/EMA meetings and regulatory interactions related to obesity and metabolic disease development., • Establish and maintain strong working relationships across clinical operations, regulatory, biostatistics, translational science, safety, and commercial teams., • Build and maintain relationships with key external stakeholders, including key opinion leaders in obesity and metabolic disease, investigators, consultants, and patient advocacy organizations. 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: • Medical Degree (MD)., • Minimum 8+ years’ experience in leading clinical studies within the biotech/pharmaceutical industry., • Experience leading studies for obesity or metabolic disease in the pharma industry, • Minimum 5 years of leadership experience with excellent line management skills., • Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills., • A proven track-record of leading clinical trials at all stages., • Expertise in the areas of drug development, clinical operations and strategic planning., • Expertise in scientific and clinical data review and interpretation, including in-depth analysis and presentation of data from strategic perspectives, • Expertise with SOPs, GCP, ICH guidelines, regulatory compliance requirements, and risk mitigation strategies., • Experience with FDA/EMA processes (IND filing, NDA filings)., • Board certification in Endocrinology, Diabetes, Metabolism or similar discipline, • Experience in operations management within a clinical research setting., • Strong leadership skills with the ability to work in a dynamic, fast-paced environment., • Strong understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Attention to detail while discriminating between critical and non-critical activities and to follow established processes., • 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, occasionally 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.

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: Artiva Biotherapeutics is seeking a skilled and highly motivated Associate Scientist who will be responsible for translational assay development and clinical sample processing, testing, and data analysis. This position will be responsible for establishing protocols, qualifying assays, and conducting in vitro testing to access pharmacokinetic and pharmacodynamic response to NK cell therapies, including immune cell activation and cytokine profiling. The successful candidate will contribute to biomarker development and analysis to support ongoing clinical trials in oncology and autoimmunity. The candidate must have experience with processing human peripheral blood and flow cytometry analysis. This position is temporary. Key Responsibilities • Collaborate with Translational teams to support clinical biospecimen receipt, processing and characterization., • Conduct cell-based assays such as immunophenotyping, cytotoxicity, cell proliferation, serum cytokine/chemokine analysis (MSD platform a plus)., • Processing human blood samples for biomarker analysis., • Assures compliance with protocols, SOPs and work practices., • Complies with standard laboratory procedures and company policies, including notebook documentation and safety protocols. Requirements • MS degree with 5+ years or BS with 8+ years of experience within the biotechnology or pharmaceutical industry., • Experience with multi-parameter flow cytometry (sample acquisition), • Demonstrate basic immunology training with strong cellular immunology and cell culture technical skills, including experience with PBMC isolation and cryopreservation., • Ability to work both independently and as part of a team,attention to detail and data qualityand demonstrating excellent communication and interpersonal skills is required., • Excellent computer skills with experience using flow cytometry analysis software, including FlowJo, Graphpad PRISM and Microsoft office., • Flexibility to work on Saturdays. 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. Base Salary: $110,000 - $115,000. Exact compensation may vary based on skills and experience.

Job Description Position days and hours - Tuesday to Saturday, 9:00 am to 5:30 pm Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 30 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 30 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Medical Laboratory Technician I/II. The Medical Laboratory Technician is responsible for training, receiving, and accessioning specimens for testing, assisting Clinical Laboratory Specialists, and pre-analytical testing for specimens received. S/he will perform basic clinical testing procedures, basic data entry, and filing functions for the clinical laboratory. The Medical Laboratory Technician will also provide professional customer service to our clients. Core Responsibilities Include: • Performs all aspects of pre-analytic workflow to ensure orders are entered correctly, specimens collected are appropriate for the test ordered and are correctly processed/transported including:, • Verifies specimens for add-on tests are available and acceptable and generates add-on test orders. Evaluates specimens for appropriateness and takes necessary corrective action. Appropriately documents unacceptable specimens., • Support operational lab staff with biorepository; organize and stores samples of biological material, blood, bone marrow aspirate, cells, and DNA., • Perform sample receiving and accessioning by following relevant SOPs., • Aid and gather information from Customer to obtain the required information required to complete the accessioning process., • Verifies specimens are correctly and completely labeled upon receipt. Evaluates specimens for appropriateness and takes necessary corrective action. Appropriately documents unacceptable specimens., • Verifies sample acceptability prior to testing., • Performs some aspects of the clinical testing protocols including:, • Semi-automated and manual DNA isolations., • Quantify and normalize isolated DNA., • Conducts biorepository activities. Collects, catalogs, and stores samples of biological material for laboratory research as well as patient testing., • Operate laboratory equipment, such as centrifuges, automated cell counters, UV-Vis Spectrophotometer, fluorometer, etc. Use automated equipment that analyzes multiple samples at the same time., • Performs a quality secondary review of work such as accessioning as well as data entry in logs to ensure accurate information., • Performs some aspects of the post-analytic workflow including: distribution of results, filing testing documentation, archiving samples, and checking for data entry errors., • Ensures quality of operations:, • Performs required Quality System responsibilities including initiating “Quality Occurrence Reports, Customer Complaints,” etc., • Meets competency standards of the department., • Ensures that personal continuing education requirements are met., • Ensures integrity of Laboratory Information Management System (LIMS) by following established protocols and participating in the maintenance and enhancements of the LIMS., • Follows all required safety procedures, assumes a proactive role in laboratory safety. Follows all required privacy, safety, and biohazard procedures and standards., • Provides customer service excellence:, • Answers telephones when needed, using proper telephone etiquette., • Adheres to HIPPA and PHI standards; maintains patient confidentiality., • Sends reviewed results to clients., • Performs inventory control activities related to Laboratory supplies in a timely, efficient, and cost-effective manner for assigned perpetual inventories by professional standards and established internal procedures. You Bring: • High School diploma, or equivalent. Some college coursework and/or relevant certification(s) preferred. Bachelor’s Degree in a related field of study highly preferred. For the MLT II, typically, 2+ years’ experience in a Clinical Laboratory, or Blood Bank environment., • Medical Laboratory Technician degree and licensed by the State of CA., • Experience analyzing complex data, troubleshoot technical issues and make valid scientific conclusions., • 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 DescriptionCompany Description CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. Job Description We are seeking a Lead Architect to drive design excellence and technical innovation across diverse project types. This role requires leadership in all phases of design—from concept through construction administration—while ensuring compliance with building codes and regulatory standards. The Lead Architect will collaborate with multidisciplinary teams, manage complex priorities, and serve as the primary architectural contact for clients, internal teams, and construction partners. Key Responsibilities • Lead and execute all phases of design: programming, planning, concept development, detailed design, and construction administration., • Produce advanced design documentation, including code analyses, life safety plans, floor plans, sections, elevations, details, schedules, and specifications for large-scale projects., • Develop studies, presentations, and reports for internal and external stakeholders., • Apply International Building Code and other regulatory requirements throughout project delivery., • Coordinate closely with engineering and construction teams to ensure constructible, integrated designs., • Oversee quality reviews, coordination meetings, and technical verification of design documents., • Support construction activities, including RFIs, submittal reviews, and progress reporting., • Assist project managers with resource planning, budgeting, scheduling, and deliverable quality., • Mentor architectural staff and act as Architect of Record for assigned projects., • Resolve complex design, code, and construction challenges.Qualifications Minimum Qualifications • Accredited professional degree in Architecture (B.Arch, M.Arch, or D.Arch) or international equivalent., • Architectural license in good standing and NCARB certification., • 15+ years of professional experience in an AEC firm., • Proficiency in Revit and Microsoft Office Suite., • Deep knowledge of International Building Codes, OSHA regulations, and ADA standards., • Strong leadership and client-focused approach., • Ability to travel moderately for projects or training., • Exceptional communication and presentation skills., • Successful track record of cross-discipline project coordination., • LEED, WELL, or similar sustainability accreditation., • Experience in CRB’s core markets: R&D labs, biotechnology, pharmaceutical, food & nutrition, consumer products, and international projects. #LI-JV1 #LI-HYBRID Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking a highly motivated and skilled Data Engineer to join our Research Informatics team within R&D. The successful candidate will play a key role in supporting Translational Genetics, Computational Chemistry, and AI/ML-driven discovery with software, AI tools, data requests, and building data infrastructure and pipelines that support immediate and longer term needs. This role will actively support Arrowhead's AI-enabled discovery initiatives by enabling high-quality, well-governed datasets for machine learning and advanced analytics. Responsibilities include preparing data for AI/ML workflows, supporting model training environments, and evaluating AI-powered tools (including LLM-based systems) to accelerate research insights, automation, and decision-making across R&D. The successful candidate will understand data and software needs for R&D teams, identify and access process gaps and opportunities to speed up research and optimize research results. This role also contributes to evaluating and deploying AI-enabled tools that enhance scientific productivity and insight. The best candidate will also design and implement robust data pipelines and architectures that integrate experimental and computational data across the research organization. A strong background in scientific informatics platforms (e.g., LIMS/ELN such as Benchling) and a passion for FAIR data principles are essential. Responsibilities • Support R&D teams with their day-to-day software, AI tools and data integration needs., • Evaluate, prototype, and adopt emerging technologies that advance data engineering, scientific AI, and research informatics capabilities., • Partner closely with Discovery Chemistry and Biology teams to ensure seamless data flow between experimental, analytical, and predictive workflows., • Develop and standardize data models and architectures to support research data management, metadata, and governance., • Build and manage integrations across scientific informatics platforms, including ELN, CDS, and analytical systems, to unify experimental and computational datasets., • Design, develop, and maintain scalable, reliable data pipelines to support R&D data integration, processing, visualization, and advanced analytics., • Influence architectural decisions that optimize data accessibility for AI development, analytics, and visualization tools., • Bachelor's or Master's degree in Computer Science, Data Engineering, Bioinformatics, or a related field., • 4+ years of professional experience in data engineering or data science, preferably within biotech, pharmaceutical, or scientific research environments., • Familiarity with data modeling, metadata management, data lineage, and data governance best practices., • Strong proficiency in Python, SQL, Git, and modern data engineering practices., • Experience with AI/ML frameworks and tooling (e.g., PyTorch, LangChain, or custom ML/AI pipelines)., • Experience supporting AI/ML workflows, including data preparation, curation pipelines, and model training environments., • Understanding of scientific data domains such as omics, assays, screening, or chemical data. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Senior Director, Business Development Invivoscribe – Improving Lives with Precision Diagnostics® 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 seeking a strategic, entrepreneurial, and relationship-focused Director, Business Development to expand Invivoscribe’s global footprint across the pharmaceutical, biotechnology, and diagnostics sectors. This is a high-impact leadership role for a true dealmaker—someone who excels at the intersection of science, strategy, and commercialization. You will architect and execute partnerships that accelerate adoption of our assays, services, and emerging offerings, helping shape the future of precision oncology. 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 Strategic Partnership Development • Identify, cultivate, and manage high-value partnerships across pharma, biotech, clinical laboratories, and diagnostic technology companies., • Lead the full deal lifecycle, including opportunity evaluation, structuring, negotiation, contracting, and operational transition., • Deliver actionable insights on market trends, competitive dynamics, customer needs, and emerging scientific advancements., • Translate complex scientific capabilities into compelling commercial opportunities and business cases., • Established network and strong relationships across pharma, biotech, and/or diagnostics to accelerate partnership development., • Proven success navigating and closing complex deal structures, including CDx, licensing, co-development, and international collaborations., • Solid understanding of drug development, flow cytometry, molecular diagnostics, clinical research, or advanced biotechnology platforms., • Bachelor’s degree in Life Sciences, Biotechnology, Business, or a related field; 10+ years of business development experience in biotech, pharma, or life sciences with a strong record of closing high-impact partnerships., • Advanced degree (MBA, MS, PhD, MPH) preferred; equivalent experience considered., • Resilient and driven. Dealmaker mentality: able to open doors to new opportunities, negotiate, and close high-value, complex deals. At Invivoscribe, you will join a mission-driven global organization advancing the future of precision oncology. You will have the opportunity to shape major scientific and commercial partnerships that impact patients around the world. We offer: • Competitive compensation and performance incentives, • Comprehensive global benefits, • A collaborative, innovation-driven culture

Job DescriptionSummaryOur client, a top notch mechanical contractor, is currently seeking an experienced Plumbing Estimator for their San Diego, CA location. Backed by the strength and stability that comes with almost a century of customer care and ownership, they adhere to the highest safety standards for its employees and clients. They offer industry-leading building information modeling (BIM) capabilities, design/build services, sustainable solutions, commercial HVAC services, and complex mechanical and industrial system installations. Plumbing estimator is responsible for all phases of the estimating and bidding process including preconstruction services and performing estimate takeoffs. Thorough knowledge of the mechanical construction bidding processes is required. Specific expertise with Plumbing systems serving hotels, student housing, laboratories, power plants, Cogeneration facilities, manufacturing facilities, clean rooms, cGMP facilities and process systems for Pharmaceutical and microelectronics facilities is desired. Ability to produce a complete detailed estimate from incomplete design documents is preferred. Duties And Responsibilities Bid document review, pre-bid meetings, client interface, quantity takeoff, material, equipment and subcontractor pricing, spreadsheet input and proposal preparation. Estimates will be prepared using Quote Express estimating software. Experience with Quote Express or other on-screen estimating software is desired. Duties also include on site and/or In-house estimating where candidate will work with professionals in design firms on design-assist and design-build projects to direct the design to meet the budget. Estimator will also interface with construction project teams and CAD detailing staff. Must have knowledge regarding safety, worker’s compensation, insurance and bonding, materials as it pertains to bidding requirements. Other duties may be assigned. Qualifications Computer Skills Proficient in MS Word, MS Excel, Bluebeam, Internet, Lotus Notes, and QuoteExpress windows-based piping and sheet metal estimating systems. Required Attributes Must possess excellent written and verbal communications skills.Maintain a professional manner in actions and appearance when representing the organization.Must prioritize in a fast paced multi-task environment with organization skills.Must have demonstrated ability to perform basic business mathematical functions.Must work with minimal supervision.Must effectively manage time and details.Must interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Must have organizational skills in handling & archiving technical data.Must comply with all operating policies, procedures, plans, and programs. Prefer a minimum of 3-5 years mechanical construction experience and proficiency in the preparation of large and complex bid proposals of all types. Language Skills Must have the demonstrated ability to effectively communicate, cooperate, and collaborate with multiple levels of employees, vendors, and suppliers.

Job Description Job Description: ADARx is seeking a qualified and highly motivated individual Lab Manager to join the R&D Department. The Lab Manager will provide operational and scientific support for a fast-paced biotechnology research environment to ensure smooth functioning of the lab while maintaining compliance with safety standards. This role is ideal for a highly experienced professional who can operate independently, proactively manage laboratory operations, and ensure the efficient, compliant, and safe execution of research activities. The Lab Manager will serve as a key partner to scientific teams, requiring minimal supervision and a strong ability to anticipate and resolve issues. Essential Responsibilities: • Oversee day-to-day laboratory operations to ensure efficiency, organization, safety, and compliance (e.g., company policies, OSHA, EPA, EHS, local guidelines)., • Oversee proper functioning and maintenance of all laboratory equipment, including calibration, maintenance and repairs., • Serve as a liaison with external vendors and landlord, manage service contracts, and operate as the primary point of contact for lab-related issues, troubleshooting independently when possible., • Manage shipping and receiving of laboratory materials, including reagents, and samples, ensuring proper compliance with company’s policies and IATA shipping certificate., • Oversee inventory management, ordering, and stock levels for reagents, consumables, and supplies; maintain equipment inventory., • Lead lab safety programs, including chemical hygiene, waste disposal, emergency procedures, safety inspections and training., • Support onboarding and training new lab personnel on lab protocols and safety practices., • Implement best practices to support a growing and evolving R&D organization, including establishing, maintaining and improving lab processes, SOPs and workflows., • Manage lab scheduling, space utilization, and shared equipment across Discovery Biology and Discovery Chemistry research teams., • Partner closely with scientists, IT, Legal, and external vendors and act as a trusted operational advisor to internal stakeholders and research leadership., • Identify opportunities to streamline operations, reduce costs, and improve productivity., • Anticipate future lab needs based on scientific and business demands., • Oversee day-to-day laboratory and vivarium operations to ensure efficiency, organization, safety, and compliance (e.g., company policies, OSHA, EPA, EHS, local guidelines)., • Bachelor’s degree in Biology, Chemistry, Biochemistry, or a related scientific field., • Minimum of 5 years of experience managing laboratory operations in a pharmaceutical, biotech, or life sciences environment., • Demonstrated ability to work independently with minimal supervision., • Strong knowledge of laboratory safety, compliance standards, and best practices., • Proven experience managing equipment, vendors, and lab budgets., • Experience supporting discovery and/or development-stage research., • Must be able to work independently with supervision as needed., • Must be collaborative and work well with other team members in a matrix team environment., • Excellent written and verbal communication skills are essential for this role., • Strong organizational skills with attention to detail and accuracy., • Ability to maintain a high level of confidentiality and exercise discretion., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges., • Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Occasional after-hours availability may be required to respond to critical equipment alarms or other urgent laboratory matters. 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. Compensation: • This is a full-time position, Monday-Friday, • Pay is commensurate with experience, • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-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 highly regarded investors. 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 DescriptionAbout Radionetics Radionetics Oncology, a pharmaceutical company focused on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications, is poised to capitalize on the increasing demand for novel radiotherapeutics. The company’s platform technology uses small molecule targeting to deliver therapeutic radioisotopes aimed at novel targets on a broad range of cancers by binding selectively to peptide receptors that are overexpressed on these tumors. This small molecule technology addresses many of the significant challenges currently facing peptide and protein targeted radiotherapeutics. Spun out of Crinetics (Nasdaq: CRNX) in 2021 and financed by 5AM Ventures and Frazier Healthcare, Radionetics is advancing a pipeline of multiple lead drug candidates pursuing first-in-class targets to treat a broad range of cancers. According to commercially available market research reports, the market for radiopharmaceuticals is expected to rise to $12.6 billion by 2027. For more information, visit . Position Summary The Senior Accountant will play a critical role in the day-to-day financial operations of Radionetics. This individual will be a key contributor in the month-end close process, manage the accounts payable function, and assist with the technical execution of clinical trial accruals. The ideal candidate is a Big 4-trained CPA who is ready to transition into a hands-on biotech environment, bringing a high level of technical rigor and "audit-ready" documentation to a growing R&D organization. This role reports to the Senior Manager of Accounting and will work closely with the Controller, CFO, and other cross-functional teams. Essential Job Functions and Duties • General Ledger & Close: Assist with the month-end, quarterly, and year-end close procedures. Prepare journal entries and account reconciliations related to cash, prepaids, fixed assets, and general accruals and assist with the R&D accounting and clinical trial accruals process. Prepare monthly financial statements and flux analyses., • Purchasing: Oversee the end-to-end purchasing workflow to ensure proper coding, internal approvals/compliance with controls, and vendor management. Serve as day-to-day accounting resource for internal stakeholders for all purchasing and contracting inquiries., • AP Oversight: Review and manage all aspects of accounts payable process., • Internal Controls: Maintain and strengthen internal controls over financial reporting and ensure all processes are "IPO-ready.", • Payroll: Process semi-monthly payroll, including collection of relevant support documentation and approvals. Support headcount, payroll, and benefits-related accounting entries/reconciliations., • Audit Support: Serve as a point of contact for external auditors, preparing work papers and providing technical explanations for accounting treatments., • Clinical Trial Accounting: Assist in the month-end clinical accrual process. Collaborate cross-functionally with Clinical Operations and CROs to track patient enrollment, site activities, and milestone payments to ensure accurate expense recognition., • Special Projects: Support the Controller/CFO with ad hoc technical accounting research, tax filings, and preparation of materials for board meetings.Minimum Required Qualifications, • Education: BA/BS in Accounting; CPA license is required., • Experience: 2–4 years of progressive accounting experience. Public accounting experience is required., • Industry Knowledge: Previous experience in the Life Sciences/Biotech sector is preferred, specifically regarding clinical trial accruals and R&D accounting., • Technical Skills: Strong understanding of U.S. GAAP and SOX compliance., • Systems: Proficiency in Excel (advanced formulas, pivot tables), experience with Quickbooks, Prendio, Bill.com, Expensify is preferred., • Communication: Ability to translate complex accounting concepts for non-finance stakeholders (e.g., Project Managers and Scientists). Compensation & Benefits Radionetics has a competitive total compensation package that includes bonus opportunity; equity; medical, dental, vision, life, short-term, and long-term disability insurance; 401(k) retirement plan with employer match; 4 weeks of paid time off (PTO) annually; and generous paid holidays. Pay Range: $95,000 - $120,000 Radionetics evaluates a variety of factors in determining individual pay decisions, which may include relevant education, experience, and skills; internal equity; complexity and responsibility of the role; and market demand relative to the position. Geographic location may also be a consideration in evaluating salary when candidates work in states outside of California. Important notices Radionetics Oncology, Inc. is committed to a policy of equal opportunity in which all qualified applicants receive equal consideration for employment without regard to race, color, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, military or veteran status, or any other federal, state or local protected class. The job description specifics provided above are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and requirements. Radionetics retains the right to add or change duties, education, experience, skills or any other requirements of the position at any time. Radionetics does not accept unsolicited referrals from employment agencies for position vacancies unless written authorization is provided from the Human Resources department before any candidates are referred for specific identified positions. In the absence of such written authorization, any actions taken by the employment business/agency shall be deemed to have been performed without consent or contractual agreement, and Radionetics shall not be liable for any fees arising from such actions or referrals for position vacancies at Radionetics. Powered by JazzHR QMAb0KnsGi

Job 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 DescriptionLife Sciences Partnering & Licensing Attorney Locations: Boston, Palo Alto, San Diego Practice Area: Life Sciences Partnering Direct Counsel is seeking a Life Sciences Partnering & Licensing Attorney to join a highly regarded firm with a nationally recognized Life Sciences Corporate Partnering & Licensing practice. This is an excellent opportunity for an associate with experience in strategic commercial transactions within the life sciences sector. Key Responsibilities: • Structure, negotiate, and draft strategic commercial transaction agreements, including licenses, collaboration agreements, and other commercial contracts., • Advise life sciences clients on complex partnering and licensing transactions in both domestic and international markets., • Work closely with corporate, regulatory, and intellectual property teams to support clients in the biotech, pharmaceutical, and medical device industries.Qualifications & Skills:, • 3-6 years of experience representing life sciences companies in strategic transactions, either in a law firm or in-house setting., • Strong background in commercial transactions, licensing, and collaborations within the life sciences industry., • Corporate or patent experience and/or a technical degree is a plus., • Excellent drafting, negotiation, and communication skills.Compensation & Benefits:, • Salary Range: $260,000 - $390,000 (Final offer dependent on experience and location)., • Comprehensive medical, dental, and vision benefits., • Firm-paid life insurance, disability coverage, and parental leave., • Generous vacation, sick leave, and paid holidays. Apply to learn more!

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. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 30 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 30 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Senior Bioinformatics Scientist. The Senior Bioinformatics Scientist is a hands-on technical leader with advanced knowledge of scientific principles and concepts who designs, builds, and validates production-grade bioinformatics software and scalable NGS pipelines (on-prem and cloud) to diagnose and track disease (MRD) for clinical and research applications. This role independently identifies opportunities, defines technical roadmaps, and leads delivery from requirements and design through implementation, verification/validation, release, and lifecycle support. Core Responsibilities Include: • Lead the design and development of bioinformatics software and pipelines to support Whole Genome Sequencing (WGS), hybrid-capture, and amplicon based NGS assays., • Work in close collaboration with the R&D and clinical lab teams, representing bioinformatics from a technical leadership role., • Evaluate and develop novel methods and external tools; perform benchmarking and method comparisons, and document recommendations and decisions; own projects end-to-end., • Develop reproducible, testable bioinformatics software using modern engineering practices (git, code review, unit/integration tests, CI/CD, containerization), and workflow technologies (e.g., Nextflow)., • Apply deep Next Generation Sequencing (NGS) analytics expertise and partner with scientific stakeholders to translate bioinformatics outputs into actionable conclusions., • Lead bioinformatics software development for CAP/CLIA/NYA environments, including requirements definition, design documentation, verification and validation planning/execution, traceability, change control, and release documentation., • Ph.D. degree in bioinformatics, computational biology, molecular biology, or related field with, typically, 8+ years applicable post-graduate experience. M.S. degree in bioinformatics or related field and 10+ years of applicable post-graduate experience. Equivalent combination of education and experience may be considered., • Advanced proficiency with Linux and strong programming skills (Python, bash required; additional languages welcome)., • Experience building and/or leveraging AI agents and LLMs for various tasks and optimization of software development., • Demonstrated experience designing and building production bioinformatics pipelines for WGS/WTS assays., • Hands-on experience developing and operating bioinformatics software in the cloud, including workflow execution at scale and management of compute/storage costs., • Experience collaborating across multi-disciplinary teams and providing technical leadership through influence (with or without direct reports)., • Strong foundation in statistics and quantitative analysis of biological datasets., • Extensive background in immunology or cancer research is highly preferred., • Experience developing software in a regulated environment is a plus (e.g. IVD, IVDR, CAP/CLIA/NYS)., • 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.

Job DescriptionAbout Us: CompassX is a boutique business and technology consulting firm. We help Fortune 500 and high-growth clients deliver their most strategic initiatives, from enterprise transformations to digital and data-driven projects. With over 15 years of proven results, we’ve expanded across industries including financial services, pharmaceuticals, aerospace, consumer products, and quick service restaurants. We are honored to be recognized as a three-time winner of Consulting Magazine’s Best Boutique Firms to Work For, and previously recognized as a “Best Place to Work” in Southern California and one of INC.’s 5000 fastest-growing private companies in the U.S. We are looking for a high-impact IT Manager - Finance Systems to serve as the strategic bridge between corporate G&A functions, specifically Finance, Supply Chain, and Legal and technical execution. This role is ideal for a "Delivery-First" professional who can navigate the complexities of a heavily regulated environment while maintaining the agility of a high-growth business. You will be responsible for the health and evolution of enterprise platforms like NetSuite and Coupa, ensuring that every solution is built with clarity, measurable business value, and strict SOX compliance.What You'll Do • Act as the "Translator" by converting complex business requirements from Finance and Supply Chain stakeholders into actionable technical designs., • Drive end-to-end delivery of system initiatives, managing the full lifecycle from initial requirements gathering and solution design through to User Acceptance Testing (UAT) and deployment., • Ensure rigorous compliance with corporate and governmental policies, specifically maintaining high standards for SOX and 21 CFR Part 11., • Provide hands-on administration and technical support for core G&A platforms, including NetSuite ERP and Coupa (Procure-to-Pay)., • Manage complex project roadmaps, financials, and timelines, acting as the single source of truth for G&A system health and evolution., • Partner with cross-functional leadership to identify process improvements and redesign workflows for better scalability and user experience., • Oversee data integrity and financial reporting accuracy across analytics platforms such as Power BI or Tableau.What You'll Bring, • 5+ years of experience providing direct technical and functional support for G&A financials, procurement, and legal applications., • Deep functional expertise in NetSuite ERP (Finance, Supply Chain, Inventory) and Coupa (Procure-to-Pay)., • Strong industry background, specifically within the Biotech or Pharmaceutical sectors, navigating fast-paced, high-growth environments., • Proven track record in technical project management, with the ability to manage shifting priorities and make effective decisions under pressure., • Solid understanding of compliance frameworks, including SOX and 21 CFR Part 11., • Exceptional communication skills, with the ability to articulate technical concepts to non-technical business stakeholders clearly.

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

Job DescriptionJanux Therapeutics is seeking a hands-on, execution-driven Clinical Pharmacology Lead to support the design, analysis, and interpretation of clinical pharmacology strategies across our development programs. This role is ideal for a scientific contributor who thrives on working directly with data, ensuring high-quality PK analysis, and enabling data-informed decisions for dose selection and regulatory filings.This position is focused on executional excellence, not modeling ownership. PK/PD modeling and simulation may be supported externally, while this role ensures internal strategic alignment and scientific rigor in clinical pharmacology deliverables.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Serve as the Clinical Pharmacology Lead across multiple programs, owning the execution of clinical pharmacology plans from IND through early clinical development., • Design and oversee PK, PK/PD, and exposure-response analyses to support dose selection, study design, and benefit-risk assessments., • Lead the development and execution of clinical pharmacology components of studies, including food effect, drug-drug interaction, organ impairment, and QT assessments., • Author and review clinical pharmacology sections of regulatory documents (e.g., INDs, NDAs, briefing books) and support regulatory interactions., • Ensure proper bioanalytical sampling strategies, assay validation, and data quality across studies., • Collaborate with Translational Medicine and Biomarker teams to integrate mechanistic and biomarker data into PK/PD interpretation., • Work closely with Biometrics and external modeling partners to support population PK and exposure-response modeling., • Stay current with regulatory guidance and scientific advances in clinical pharmacology, applying best practices to development programs., • Contribute to program-level planning and prioritization based on pharmacological insights and development risk., • Other activities as required.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Ph.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related field., • 6+ years of experience in clinical pharmacology and/or pharmacometrics in the biotech or pharmaceutical industry., • Direct experience designing and executing early-phase clinical studies, including healthy volunteer studies., • Strong expertise in PK analysis and exposure-response interpretation; experience in oncology or biologics preferred., • Familiarity with T cell engagers (TCE) and managing external Clinical Pharmacology resources., • Proven track record of contributing to regulatory submissions and engaging with health authorities., • Excellent communication, collaboration, and organizational skills., • Ability to work independently and in a fast-paced, matrixed environment., • Ability to travel up to 15%In addition to a competitive base salary ranging from $232,000 to $254,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor’s product lifecycle, with primary accountability for Deramiocel’s BLA pathway and advancement of other pipeline candidates from development through potential commercial approval and post-approval maintenance. Reporting to and collaborating closely with the VP of Regulatory Affairs, this role develops and executes CMC regulatory strategy, ensures compliance with global requirements (FDA, ICH, EMA), identifies and mitigates risks, and partners with cross-functional teams (CMC Development, Manufacturing, Quality, MSAT, Supply Chain, and others) to drive successful submissions, health authority interactions, and company objectives in a fast-paced, mission-driven biotech environment.Responsibilities • Develop, own, and execute CMC regulatory strategy across the product lifecycle (from development through commercial and post-approval phases) in alignment with global regulatory requirements and Capricor’s overall regulatory and business goals., • Oversee and lead the preparation, authoring, review, final approval, compilation, and submission of CMC sections for major regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, MAAs, responses to queries/information requests, and post-approval changes)., • Proactively identify risks related to documentation, content, quality, or timelines for global CMC submissions; collaborate with Manufacturing, Quality, Process Development, MSAT, and other departments to ensure timely delivery of approved, high-quality technical source documents., • Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, process validation summaries, comparability protocols, and deviation/investigation reports., • Foster CMC regulatory alignment and phase-appropriate readiness by collaborating with supporting departments (Manufacturing, Quality Assurance, MSAT, Supply Chain, Commercial, etc.) to support development, scale-up, validation, and commercial readiness activities., • Review and approve product labeling with responsibility for CMC-related claims, product descriptions, manufacturing statements, and participate in Advertising & Promotion review committees as needed., • Manage, mentor, and develop regulatory affairs professionals; provide leadership, oversight, accountability, and support to ensure high-performance deliverables and team growth., • Serve as the primary CMC interface with health authorities (primarily FDA for biologics/cell therapies, potentially EMA) for submissions, negotiations, formal meetings (e.g., Type meetings, pre-BLA interactions), and responses to queries or deficiencies (including addressing any CMC-related items from the Deramiocel CRL)., • Monitor global regulatory trends, guidelines, and precedents (e.g., ICH Q updates, FDA guidance on CMC for cellular/gene therapies, advanced therapies) and adapt Capricor’s CMC strategies proactively to maintain compliance and competitive advantage., • Contribute to regulatory risk assessments, gap analyses, contingency planning, and inspection readiness for CMC aspects and manufacturing sites., • Perform such other duties as may be assigned from time to time.Requirements, • Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) preferred., • 8+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, including significant experience with biologics, cell therapies, or regenerative medicine products; commercial-stage product experience (post-approval lifecycle management) highly preferred., • Proven track record of preparing, authoring, leading, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including successful responses to agency queries, deficiencies, or Complete Response Letters., • In-depth knowledge of global regulatory requirements and guidelines relevant to CMC for biologics and cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, process validation, stability, comparability, potency assays)., • Experience supporting BLA or similar submissions for advanced therapy products, with familiarity in addressing CMC issues in late-stage reviews or post-CRL scenarios preferred., • Strong project management skills with the ability to lead multiple complex projects, manage timelines, resources, and cross-functional dependencies in a dynamic environment., • Exceptional communication skills (written and verbal) for effective interaction with internal teams, external partners, and health authorities, including authoring clear regulatory documents and presenting strategies., • Proficiency in regulatory information management systems and tools (e.g., Veeva RIM, document authoring/publishing software)., • Demonstrated leadership abilities, including mentoring and developing team members, fostering collaboration, and driving accountability., • Ability to work strategically and independently while thriving in a collaborative, fast-paced setting.Work Environment / Physical Demands, • Primarily office-based with tasks involving regulatory documentation, strategy development, and cross-functional/global coordination., • Requires prolonged periods of computer use for drafting, reviewing, compiling, and reporting on CMC documents and submissions., • May involve lifting office materials up to 15 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Manufacturing Lead - 1st Shift - $26/hr-$28/hr Job Description The Manufacturing Lead plays a crucial role in guiding the team to achieve weekly production goals and manufacturing yields. This position involves operating manufacturing equipment and monitoring progress towards achieving manufacturing goals. The individual will ensure adherence to all Good Manufacturing Practices (GMP) and related standard operating procedures (SOPs), while supporting staffing needs and managing shift rotations and breaks. Responsibilities • Operate manufacturing equipment while monitoring production goals., • Ensure compliance with Good Manufacturing Practices (GMP) and related SOPs., • Monitor team's documentation practices according to Good Documentation Practices (GDP)., • Support staffing needs and manage shift rotations and breaks., • Lead departmental training activities and maintain compliant training records., • Evaluate and pilot new manufacturing technology to minimize initial and subsequent production issues., • Maintain accurate records and documentation as per GDP and SOPs., • Track and implement corrective action protocols., • Coordinate corrective action for technical problems with raw materials and finished products., • Three (3) to five (5) years of related manufacturing experience in a regulated medical device or pharmaceutical environment., • Previous leadership experience in a manufacturing setting, ideally having led a team of 20., • Understanding of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP)., • Familiarity with FDA regulations and quality processes., • Experience in production management, assembly, and process improvement., • Knowledge of cleanroom operations and medical device assembly. Join a supportive environment that offers a clear path to full-time employment with a raise upon conversion after four months. Enjoy quarterly events and activities that foster team spirit and camaraderie. Benefit from an 8% employer match on your 401(k) and enjoy paid holidays. Work Environment Work on the Cuvettes team with a schedule from 6am to 2:30pm. Training will take place on the first shift with hands-on guidance from the manufacturing manager. The work setting is a cleanroom where specific dress codes apply, including no leggings, face makeup, or lipstick. Glasses wearers must use side shields, and hair nets and beard covers are mandatory. Job Type & Location This is a Contract to Hire position based out of San Diego, CA. Pay and Benefits The pay range for this position is $26.00 - $28.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in San Diego,CA. Application Deadline This position is anticipated to close on Feb 11, 2026. About Aerotek: We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

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 DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor’s product lifecycle, with a primary focus on supporting the BLA pathway for Deramiocel and advancing other pipeline candidates from development through potential commercial approval and post-approval maintenance. This role supports the development and implementation of CMC regulatory strategy, ensures compliance with global regulatory requirements (including FDA, ICH, and EMA guidelines), and partners closely with cross-functional teams (e.g., CMC Development, Manufacturing, Quality Assurance, Clinical, and Regulatory) to enable timely submissions, successful interactions with health authorities, and achievement of company objectives in a dynamic biotech environment.Responsibilities • Support the development and execution of CMC regulatory strategy across the product lifecycle (development through commercial and post-approval) to ensure regulatory compliance and alignment with global requirements., • Lead the preparation, authoring, review, compilation, and submission of CMC sections for regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, responses to information requests, and post-approval changes)., • Collaborate with internal CMC, Manufacturing, Quality Assurance, Process Development, and other supporting departments to ensure timely generation, review, and approval of source documents required for regulatory submissions (e.g., stability data, comparability protocols, process validation reports)., • Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, validation master plans, and deviation investigations., • Interface directly with health authorities (primarily FDA, potentially EMA) for CMC-related submissions, negotiations, meetings (e.g., Type meetings, pre-submission interactions), and responses to queries or deficiencies (including addressing any outstanding CMC items from prior BLA feedback)., • Monitor evolving global regulatory changes, guidelines, and precedents (e.g., ICH updates, FDA biologics guidance for cell therapies) and assess impacts on Capricor projects, providing proactive recommendations to leadership., • Contribute to regulatory risk assessments, gap analyses, and contingency planning for CMC aspects of submissions and lifecycle management., • Support inspection readiness activities related to CMC documentation and manufacturing sites., • Perform such other duties as may be assigned from time to time.Requirements, • Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) preferred., • 5+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, preferably for biologics, cell therapies, or advanced therapy medicinal products (ATMPs)., • Demonstrated experience preparing, authoring, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including responses to agency queries., • Solid knowledge of global regulatory requirements and guidelines relevant to CMC for biologics/cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, comparability, process validation, stability)., • Experience supporting BLA or similar submissions for regenerative medicine products, with familiarity in addressing CMC deficiencies or Complete Response Letters preferred., • Strong project management skills with the ability to manage multiple projects, timelines, and priorities in a fast-paced environment., • Excellent communication skills (written and verbal) for effective interaction with internal stakeholders, external partners, and health authorities., • Proficiency in regulatory document management systems and tools (e.g., Veeva RIM, document authoring software)., • Ability to work independently while collaborating cross-functionally with scientific, manufacturing, and quality teams.Work Environment / Physical Demands, • Primarily office-based with tasks involving regulatory documentation, strategy development, and cross-functional coordination., • Requires prolonged periods of computer use for drafting, reviewing, compiling, and reporting on CMC documents and submissions., • May involve lifting office materials up to 15 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Information Systems & Informatics Quality Systems Manager is responsible for the ownership, oversight, and continuous improvement of enterprise Quality Systems and associated systems that support regulated business processes. This role ensures that Quality Systems are compliant, validated, and effectively support the business. The position serves as key liaison between IS&I and Quality, with a strong focus on Business process & configured system effectivity, continuous improvement, regulatory compliance, system lifecycle management, and audit readiness. Responsibilities • System Owner - manage electronic QMS and processes, including Change Control, Deviations, CAPAs, SCARs, Audits, Findings, Suppliers, Complaints Management, Batch Release Management, Document Management, Training, etc., • Ensure systems align with established Quality System procedures and business process requirements., • Identify and lead continuous improvement initiatives to enhance system usability, compliance, and efficiency., • CSA.CSV expertise, • Regulatory Applicability Assessments/Risk assessments, • IQ/OQ/PQ documentation, • Periodic review, • Create and manage system changes through formal change control processes., • Ensure proper system configuration, access control, data integrity, and backup/recovery practices., • Cross-Functional Collaboration, • Partner with business partners to ensure systems effectively support business needs., • Act as a subject matter expert (SME) for Quality systems & Processes across the organization. Requirements • Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, or related field., • 7+ years of experience implementing/supporting GxP-regulated IT systems within pharmaceutical, biotech or equivalent Commercial Operations background., • Strong knowledge of Quality Systems and QMS business processes., • Hands-on experience with system validation and compliance in regulated environments., • In-depth understanding of 21 CFR Part 11, EudraLex Annex 11, and data integrity principles., • Experience supporting audits and regulatory inspections., • GxP compliance and regulatory knowledge, • CSA/CSV expertise, • Quality mindset with strong attention to detail, • Excellent communication and stakeholder management skills, • Ability to balance compliance requirements with business efficiency, • Leadership in cross-functional, matrixed environments Preferred: • Direct Veeva Vault Quality administration experience., • Experience supporting automation, engineering, commercial manufacturing, quality operations. Wisconsin pay range $120,000—$150,000 USDCalifornia pay range $130,000—$165,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Position: Business Development Director Location: Onsite - San Diego, California Position Type: 5 days Onsite Exempt Position Salary Range: $100,000-$200,000 Job Summary: We are seeking an experienced and strategic Business Development Director to drive growth, partnerships, and revenue expansion within the biotechnology industry. This role is responsible for identifying new business opportunities, cultivating relationships with key stakeholders, and leading strategic initiatives to enhance market presence. The ideal candidate will have a strong background in biotech, life sciences, or pharmaceuticals, along with expertise in strategic partnerships, licensing, and market expansion. Key Responsibilities: • Strategic Planning & Commercialization, • Develop and execute business strategies aligned with corporate objectives., • Lead full business cycles, including market entry, product expansion, and transformation during decline phases., • Implement pricing strategies, optimize channel mix, and allocate resources to balance short-term profitability with long-term growth., • Example: Created a 3-year growth roadmap that elevated market share from Top 5 to Top 2., • Team Leadership & Organizational Development, • Build and restructure medium-to-large teams, ensuring a strong talent pipeline., • Lead teams through cultural and structural mechanisms rather than direct authority., • Revitalize legacy teams to drive engagement and prevent stagnation., • Example: Transformed a commission-based sales team into a triad model (sales + solution + delivery), increasing efficiency by 50%., • Resource Integration & Ecosystem Building, • Establish and manage strategic partnerships across industries and regions, including government relations, supply chain alliances, and capital partnerships., • Design win-win partnership frameworks to enhance business growth., • Leverage external opportunities such as policy incentives, industry expos, and media PR., • Example: Partnered with industry associations to establish standards, making the company’s product a recommended industry solution., • Data-Driven Operations & Risk Management, • Utilize financial models (e.g., LTV, CAC) to optimize business performance., • Build and implement business health metrics, including cash flow alerts and inventory turnover strategies., • Identify and mitigate risks related to channel arbitrage, over-reliance on key clients, and compliance challenges., • Example: Implemented a dynamic pricing system to stabilize gross margins amid raw material price fluctuations., • Change Leadership & Crisis Management, • Navigate industry disruptions, such as regulatory shifts and technological obsolescence, leading successful transformations., • Manage enterprise-level crises, including brand reputation issues and executive departures., • Build team consensus through town halls, incentive realignment, and agile decision-making., • Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Business Administration, or a related field. An MBA or Ph.D. is a plus., • 10+ years of business development experience in the biotech, pharmaceutical, or life sciences industry., • Proven track record in strategic partnerships, licensing, and deal negotiations., • Strong network and relationships within the biotech and life sciences sector., • Excellent communication, negotiation, and leadership skills., • Ability to analyze market trends, competitive landscapes, and financial data to drive business decisions., • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development

Job 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 Job Description: ADARx is seeking a qualified and highly motivated individual at the QA Associate III level to join the Quality Assurance (QA) group. This is a key role within the QA group and offers exciting opportunity for the successful candidate to make major contributions to the development, implementation and maintenance of the Quality Management System (QMS) at ADARx. This role will collaborate closely with CMC and Clinical functions at ADARx to ensure that quality practices, procedures, standards and systems are established and followed to maintain compliance to applicable cGxP regulations. Essential Responsibilities: • Assist in the development, implementation, improvement and maintenance of ADARx’s overall Quality Management System (QMS)., • Support the implementation of an electronic Quality Management System (eQMS) and act as the administrator to ensure proper configuration and usage of the system. Provide training and support to eQMS users., • Provide QA support and oversight to internal staff and suppliers to ensure compliance with SOPs and relevant cGxP requirements., • Manage the Document Control process for creating or revising controlled documents following internal procedures., • Manage the training program and ensure all GxP related personnel receive appropriate training. Maintain and update training files and training curricula., • Support the development of QA-related training materials and provide QA process training to new and existing employees., • Author, review, and approve Quality System records, including deviation, CAPA, change records, etc., • Author, review, and approve controlled documents for QA and other functional areas., • Conduct and support supplier qualification activities, including issuance and review of quality questionnaires, supplier audits, and review of quality agreements., • Manage supplier files and the approved supplier list to ensure they are accurate and up-to-date., • Support internal audits, including planning, risk assessment, scope, audit program development, fieldwork, reporting and action follow-up., • Collect and summarize Key Quality Indicator (KQI) metrics for review to identify trends., • Support the preparation and hosting of regulatory inspections and external audits. 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: • BS/MS degree in a related scientific or technical discipline, • 6+ years of experience in the biotech/pharmaceutical industry, • 4+ years of experience in the QA function in a cGxP environment, • Strong understanding of cGMP and ICH regulations and guidance, • Demonstrated experience in development and implementation of quality processes, procedures and systems, • Previous experience in a GMP QC lab or manufacturing environment preferred, • GCP experience a plus, • Must be able to work independently with supervision as needed., • Must be collaborative, work well with other team members in a matrix team environment., • Excellent written and verbal communication skills are essential for this role., • Strong organizational skills with attention to detail and accuracy., • Ability to maintain a high level of confidentiality and exercise discretion., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-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 highly regarded investors. 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 Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Supply Chain Manager Location: Onsite - Atlanta, or San Diego Salary Range: $80,000 - $120,000 Job Overview The Supply Chain Manager oversees supply chain and logistics operations to ensure efficiency, productivity, and compliance within the pharmaceutical manufacturing industry. This role involves developing strategies, monitoring performance, and implementing policies to optimize processes, reduce costs, and align supply chain activities with company objectives and regulatory standards. Key Responsibilities • Strategic Planning: Design and implement supply chain strategies to meet company goals, forecast demand, and adapt to market changes., • Operations Management: Oversee procurement, production, warehousing, and distribution, ensuring seamless operations and optimized workflows., • Vendor Relations: Manage supplier relationships, negotiate contracts, and evaluate performance for quality and cost-effectiveness., • Inventory & Demand: Maintain optimal inventory levels, implement control techniques, and align production with customer trends., • Logistics: Coordinate transportation and work with third-party logistics (3PL) providers to ensure timely deliveries., • Cost Management: Monitor costs, create budgets, and implement savings strategies while maintaining quality standards., • Data Analysis: Analyze supply chain performance metrics and recommend process improvements., • Risk Management: Identify risks, ensure regulatory compliance, and enforce health and safety policies. Education & Experience: • Bachelor’s degree in Supply Chain, Logistics, Business, or related field., • Strong knowledge of supply chain processes, logistics, compliance, and quality assurance., • Proficiency in ERP and supply chain software (e.g., SAP, Oracle)., • Excellent organizational, project management, and leadership abilities., • Advanced Education & Certifications: Master’s degree or certifications such as CPIM, CSCP, or CLTD., • Industry & Regulatory Knowledge: Familiarity with FDA, GMP, and ISO 13485 regulations. Experience in global logistics and applying lean supply chain principles., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job 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 Associate I/II, Regulatory Operations will provide essential regulatory operations and document management support across Capricor’s development and potential commercial programs. This role is primarily responsible for tracking regulatory deliverables, maintaining document repositories and archives, and assisting with submission readiness, publishing, and lifecycle management activities. The Associate will collaborate closely with Regulatory Affairs, CMC, Clinical, Quality, Manufacturing, and other cross-functional teams to ensure regulatory documents are complete, accurate, current, and readily available to support BLA submissions, regulatory interactions, and ongoing compliance in a fast-paced biotech environment.Responsibilities • Track regulatory deliverables, milestones, and timelines across development programs (including BLA-related activities for Deramiocel), ensuring visibility, proactive risk identification, and on-time completion., • Maintain regulatory document repositories (e.g., eCTD-compliant systems), including version control, accuracy checks, and archival of approved/final documents., • Support regulatory publishing activities, including document compilation, formatting, quality checks, hyperlinking/bookmarking, and coordination of submission components under guidance from Regulatory Affairs., • Coordinate with cross-functional teams (Regulatory Affairs, CMC, Clinical, Quality, Manufacturing, etc.) to collect, track, and organize required submission deliverables and supporting documentation., • Perform detailed document quality checks to ensure formatting, completeness, consistency, and adherence to regulatory standards (e.g., FDA eCTD specifications), internal procedures, and ICH guidelines., • Assist in the preparation and maintenance of submission trackers, document lists, regulatory databases, and correspondence logs., • Support post-submission activities, including filing of regulatory correspondence, document updates, tracking of queries/responses, and maintenance of submission history., • Contribute to the implementation and maintenance of Regulatory Operations processes, templates, tools, and SOPs to enhance efficiency and compliance., • Monitor internal timelines and proactively communicate potential risks, delays, or issues to Regulatory Affairs leadership., • Support inspection and audit readiness by ensuring regulatory records are complete, current, organized, and readily retrievable., • Perform other duties as may be assigned from time to time.Requirements, • Bachelor’s degree in Life Sciences, Regulatory Affairs, or a closely related field., • Associate I: 0–2 years of experience in regulatory operations, document management, publishing, or a related function in the pharmaceutical/biotech industry; Associate II: 2–4 years of relevant experience in regulatory operations, regulatory affairs support, or submissions management., • Familiarity with regulatory submission structures and formats (e.g., eCTD for IND, BLA, NDA, CTD) preferred., • Experience with electronic document management systems (EDMS), publishing tools (e.g., Veeva RIM, Lorenz docuBridge, or similar), and tracking databases preferred., • Strong organizational skills with meticulous attention to detail and a high degree of accuracy., • Ability to manage multiple deliverables, prioritize effectively, and meet tight deadlines in a dynamic, fast-paced environment., • Clear and professional written and verbal communication skills to facilitate effective cross-functional collaboration., • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat for document handling and quality checks., • Knowledge of FDA regulations, ICH guidelines, and GxP principles preferred.Work Environment / Physical Demands, • Primarily office-based with tasks focused on regulatory documentation, electronic submissions, and cross-functional coordination., • Requires prolonged periods of computer use for document review, compilation, quality checking, and data entry., • 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.