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Cytek Biosciences, Inc. is a pioneering leader in advanced cell analysis solutions, transforming the field of flow cytometry with its patented Full Spectrum Profiling (FSP) technology. Cytek's innovative platforms - including the Cytek Aurora, Northern Lights, Aurora CS, and other systems - enable researchers to capture high-resolution, high-content insights by measuring the entire fluorescent emission spectrum. This advanced approach expands experimental capabilities, accelerates discovery, and makes complex analyses more accessible to scientists across academic, pharmaceutical, and biotechnology research settings worldwide. The Regional Marketing Manager (Americas) will be responsible for driving marketing strategies and initiatives that increase market share and sales revenue for Cytek's assigned product portfolio and specialized applications within the Americas region. This role requires close collaboration with cross-functional partners, including the Marcom team, platform leadership, regional sales leadership, and operations teams such as production, supply chain, and logistics. To successfully perform the essential functions of this role, the Regional Marketing Manager will: Portfolio Management * Define and execute the regional strategy for Cytek's reagent portfolio, including understanding customer needs, competitive dynamics, and pricing practices, and reporting insights to commercial leadership and product marketing. * Lead tactical planning and execution (monthly/quarterly) to build a strong sales funnel and address local/regional obstacles that may limit growth opportunities. Tradeshows & Events * Lead the strategy and execution for Tier 2-3 tradeshows and events, ensuring alignment with broader business priorities and consistent execution through standardized tools and processes. Business Reviews & Cross-Regional Leadership * Participate in quarterly business reviews for the Americas, highlighting opportunities for revenue and share growth. * Lead monthly/quarterly coordination calls with regional marketing counterparts in APAC/China and EMEA to ensure strategic alignment and knowledge sharing. New Product Introduction (NPI) & Regional Launches * Work with Global Marketing to ensure that regional business needs are incorporated into NPI planning and execution. * Drive regional launch strategies for new products, ensuring impactful and timely market introductions. Digital & E-Commerce Support * Partner with Global Marketing and platform leadership to ensure that global digital assets (websites, e-commerce platforms) meet the needs of the Americas market. Sales & Strategic Account Support * Collaborate with direct and indirect sales leadership to maximize revenue opportunities. * Support strategic account management with application insights and resource coordination to capitalize on large revenue opportunities. Market Analysis & Support * Analyze sales and market data to support progress toward market share goals in each country. * Serve as a key point of contact for documentation, technical support, and scientific resources. Representation & Distributor Coordination * Represent Cytek at key conferences and customer events as a knowledgeable ambassador for the brand. * Coordinate with distributors to ensure strong portfolio representation, consistent messaging, and alignment with Cytek brand guidelines. Candidates should meet the following criteria: * BA/BS in engineering, life sciences, biological sciences, business, or related discipline; equivalent experience will also be considered. * Minimum of 5 years of experience in scientific product management, marketing, or business development, including product line management, pricing strategy, forecasting, and supply/demand planning. * Strong customer focus with a proven track record of successful client engagements. * Excellent communication (written and verbal), interpersonal, analytical, project management, and planning skills. * Demonstrated ability to identify new business opportunities, set and achieve objectives, and build strong internal and external relationships. * Professional-level English proficiency is required; additional European language skills are a plus. * Passion for scientific technologies and a strong interest in life sciences and diagnostics is essential. * This is a field-based role requiring travel by air and/or ground, with up to 50% travel expected. * International travel is required. Salary Range: Fremont, CA: $105,000 - $131,200 San Diego: $97,000 - $121,200 Cytek Biosciences is an equal-opportunity employer. All qualified applicants will receive consideration without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.

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

Job Description Onsite: San Diego About Us • Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure., • We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need. Position Summary • The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA., • In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions., • You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams. Key Responsibilities • Support concurrent activities for legacy Quality systems during QMS integration and system migration phases., • Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems., • Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls., • Operate and support legacy Quality systems during the transition to new platforms., • Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records., • Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA)., • Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records., • Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS)., • Support continuous improvement efforts for events within EDMS and LMS., • Work with document owners to ensure timely periodic review of procedures., • Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools., • Generate and trend quality metrics, communicating findings to leadership., • Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans., • Review and approve paper-based quality documentation and electronic quality records., • Promote a culture of quality, teamwork, and accountability with a patient-first mindset., • Align daily activities with department goals and company values., • Ability to lift up to 20 pounds as needed. Qualifications • Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered)., • Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred). Technical Skills: • Strong knowledge of Quality Management Systems in a cGxP manufacturing environment., • Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training., • Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio., • Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word). Competencies: • Exceptional written and verbal communication skills., • Strong attention to detail and ability to manage multiple projects simultaneously., • Proven ability to work independently and collaboratively in a fast-paced, dynamic environment., • Experience developing training materials and delivering training to employees., • Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents. The hiring range for this position is $50 to $60 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class. #ZR

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director, Trade and Operations Strategy is a member of a team charged with ownership of end-to-end supply chain for Arrowhead products. They will define and lead enterprise-wide trade and channel operations strategy in partnership with Market Access and Commercial Leadership. This role ensures that trade architecture, distribution design, contracting infrastructure, and operational models enable optimal patient access, financial performance, and scalable growth. This position serves as the strategic integrator between Trade & Distribution and broader Market Access strategy. This role is based in onsite with an expectation to be in the office five days a week. Responsibilities Enterprise Trade Strategy • Co-develop enterprise trade and distribution strategy aligned with access and brand objectives, • Define channel architecture across buy-and-bill, specialty pharmacy, retail, and alternative distribution pathways, • Own trade-related GTN strategy in partnership with Finance, • Optimize trade terms, distribution service agreements, and fee structures, • Lead trade readiness strategy for new product launches, • Develop scalable operational playbooks for pipeline assets, • Establish KPIs for channel health, inventory management, and distribution performance, • Leverage 867/852 data, specialty pharmacy data, and channel reporting to inform strategic decisions, • Lead a team responsible for trade operations strategy, • Serve as executive partner to:, • VP Market Access, • Head of Trade & Distribution, • Finance Leadership, • Supply Chain, • Ensure government pricing and compliance considerations are embedded in trade design, • BS in Business Administration, Supply Chain/Logistics, Engineering, or other field related to the essential duties of this role., • 10+ years of relevant industry experience (7+ years in fast paced cGMP environments; 5+ years in a supply chain leadership role within the pharmaceutical industry.), • Exhibits excellent interpersonal communication, project management, collaboration, and analytical skills., • Strong MS Excel, PowerPoint, and Word skills., • Experience using Smartsheet or other work management software., • Proficient generating and presenting operational and financial metrics/KPI's., • Thorough understanding of and experience with some aspect of technical operations or CMC., • Demonstrated ability to effectively lead and influence cross-functional teams not under direct organizational reporting lines to communicate challenging goals and achieve objectives., • Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges., • Able to lead and coordinate large, complex strategy projects, with minimal direction All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Director, Global Strategic Sourcing & Procurement will lead the development and execution of global sourcing strategies across R&D, Technical Operations, G&A, and Commercial functions within a biotechnology organization. This role is responsible for optimizing supplier performance, reducing total cost of ownership, mitigating risk, and ensuring compliance in a highly regulated environment. The ideal candidate brings deep biotech/pharma category expertise (e.g., CROs, CDMOs, clinical services, lab supplies, capital equipment, IT, and indirect spend), strong negotiation capabilities, and experience building scalable procurement processes to support a growing global organization. This role is based in onsite with an expectation to be in the office five days a week. Responsibilities Strategic Leadership • Develop and execute global category strategies aligned with corporate objectives and pipeline priorities., • Lead long-term sourcing strategies across key spend categories (e.g., clinical CROs, CDMOs, CMC services)., • Drive supplier consolidation, value creation, and risk mitigation initiatives., • Establish preferred supplier programs and strategic partnerships globally., • Oversee end-to-end sourcing lifecycle: RFI/RFP, supplier selection, contract negotiation, and implementation., • Lead complex contract negotiations with global suppliers to optimize pricing, service levels, and contractual protections., • Partner with Legal to ensure contracts reflect regulatory, compliance, and IP requirements., • Implement procurement policies, systems, and controls to ensure SOX and regulatory compliance., • Drive cost savings and cost avoidance targets annually., • Serve as a strategic business partner to R&D, Clinical Operations, CMC, and G&A leaders., • Advise executive leadership on sourcing risks, market trends, and supplier landscape., • Collaborate cross-functionally with Finance for budgeting, forecasting, and spend visibility., • Establish structured supplier governance models (QBRs, scorecards, performance reviews)., • Drive continuous improvement and innovation initiatives with strategic suppliers., • Ensure suppliers meet quality, regulatory, ESG, and diversity requirements., • Lead implementation and optimization of procurement systems (e.g., Coupa, Ariba, SAP)., • Develop scalable sourcing processes appropriate for growth-stage biotech., • Establish spend analytics and reporting dashboards., • BS in Business Administration, Supply Chain/Logistics, Engineering, or other field related to the essential duties of this role., • 10+ years of relevant industry experience (7+ years in fast paced cGMP environments; 5+ years in a supply chain leadership role within the pharmaceutical industry.), • Exhibits excellent interpersonal communication, project management, collaboration, and analytical skills., • Strong MS Excel, PowerPoint, and Word skills., • Experience using Smartsheet or other work management software., • Proficient generating and presenting operational and financial metrics/KPI's., • Thorough understanding of and experience with some aspect of technical operations or CMC., • Demonstrated ability to effectively lead and influence cross-functional teams not under direct organizational reporting lines to communicate challenging goals and achieve objectives., • Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges., • Able to lead and coordinate large, complex strategy projects, with minimal direction, • Experience developing operations network strategies for a growing global market Wisconsin pay range $150,000—$170,000 USDCalifornia pay range $160,000—$180,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

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

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

Job Description Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai's portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. Your next role as a Miracle Maker Maravai LifeSciences is seeking a #MiracleMaker to join our Process Development team as a Manager, Production Operations & GMP. As a Manager, Production Operations & GMP you will lead a team of technical subject matter experts and GMP support staff to ensure efficient, compliant, and innovative manufacturing operations. This role provides technical leadership for production processes, supports technology transfers, and drives continuous improvement initiatives. Responsibilities include coaching and mentoring manufacturing teams, sustaining process knowledge, optimizing workflows, and overseeing cleanroom operations and GMP compliance. Acting as a technical liaison, the Manager will collaborate cross-functionally with Manufacturing, Quality, R&D, Supply Chain, and Commercial teams to support new product introductions, customer projects, and investigations. This position requires strong expertise in biologics manufacturing, cleanroom operations, and GMP standards, with the ability to operate semi-independently and deliver solutions in a fast-paced CDMO environment. How you will make an impact: • Lead cGMP CDMO technology transfer projects between customers and internal manufacturing teams for mRNA production., • Manage tech transfer activities for NPIs from R&D/Process Development to GMP manufacturing, ensuring reproducibility and high quality., • Provide technical oversight during technology transfer and manufacturing campaigns; assess and optimize process parameters for scalability., • Design and execute experimental protocols; analyze data and prepare technical reports., • Oversee GMP production and cleaning operations, ensuring compliance with regulatory standards and company requirements., • Review and approve controlled documents, batch records, cleaning documentation, and GMP documentation (SOPs, deviations, CAPAs, change controls)., • Train, schedule, and supervise production and support staff; maintain training matrices and job descriptions., • Coach and mentor manufacturing associates in process understanding, troubleshooting, and project management., • Serve as a technical SME for internal teams and customers, supporting investigations and inquiries., • Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Engineering, and R&D to meet production schedules and resolve issues., • Drive continuous improvement initiatives using Lean Six Sigma and statistical tools; lead root cause analyses for critical investigations., • Stay current with industry trends in modern manufacturing technologies (automation, disposable systems)., • Support audits, change controls, and Quality Risk Management programs., • Ph.D. with 2+ years, M.S. with 4+ years, or B.S. with 6+ years of experience in a scientific field (Biology, Chemistry, Biochemistry, or Engineering)., • Minimum 4–6 years of relevant experience in biotech or pharmaceutical development, including at least 2 years in a supervisory or leadership role., • Strong knowledge of cGMPs, 21 CFR 210/211, 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements., • Experience leading technology transfers, process qualification, and validation., • Familiarity with biologics manufacturing, CDMO operations, and ISO 14644 cleanroom classifications., • Ability to draft and review GMP documentation (SOPs, batch records, deviations, CAPAs, change controls, validations)., • Experience with electronic quality systems and ERP platforms (e.g., NetSuite)., • Excellent written and verbal communication skills with experience supporting strategy development and implementation., • Proven ability to manage and mentor teams, work cross-functionally, and drive strategic initiatives., • Strong collaboration skills and ability to influence across departments., • Lean Manufacturing or Six Sigma experience preferred., • Ability to implement processes that deliver measurable results and adapt best practices in novel technology environments. #LI-Onsite The benefits of being a #MiracleMaker: • You have the potential to change, improve, and save lives around the world., • You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans., • We offer comprehensive medical plans and HSA/FSA options., • Fertility & family planning assistance., • A variety of additional optional benefits and insurance options, including pet insurance., • Retirement contributions. To view more opportunities to become a #MiracleMaker, visit our career site at Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Click here to view Maravai LifeSciences Privacy Notice HIRING SCAM ALERT Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: • Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.), • Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment., • Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment. If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at . If you believe you have been a victim of fraud, you can report this activity at: or .

Job Description 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 DescriptionSales Executive – Freight Forwarding Purpose of Role Drive profitable new business through consultative, solutions-based selling across a full suite of global logistics and supply chain services. Maintain integrity, accuracy, and transparency in all revenue reporting and client discussions. Why This Is a Great Place to Work • Privately held, financially strong, and growing nationwide, • Highly respected reputation for ethics, service quality, and operational reliability, • True entrepreneurial culture — sales reps are empowered, not micromanaged, • Fast decision-making from leadership (no bureaucracy), • Best-in-class operations teams that make it easier to onboard and retain accounts, • Industry-leading technology: real-time tracking, API/EDI integrations, advanced WMS, • Strong support from regional EVP-level sales leaders, • Competitive compensation structure tied to performance, • Long-term career stability with national and international expansion plans What You Will Sell Core Freight Forwarding Services • International & domestic air freight, • International & domestic ocean freight, • FTL, LTL, cross-dock, distribution, • Bonded and FTZ services, • Storage, inventory management, • Pick/pack/ship, kitting, labeling, • E-commerce fulfillment with advanced WMS (Extensiv), • Expedited/time-definite (NFO, charter, critical shipments), • White-glove and high-value handling, • Project cargo: heavy-lift, OOG, crating, rigging, • Automotive, • AI / High-tech, • Pharmaceutical, • Aerospace, • Government / DOD, • Medical devices, • Retail / cosmetics, • Shipment management platform with real-time visibility, • Full API/EDI integration for automation, • Atlanta, • Dallas, • Houston, • Chicago, • Los Angeles, • San Diego, • San Francisco, • San Jose Requirements Core RequirementsRemote Sales Requirements • Remote roles require $2M+ annual GP Professional Standards • Demonstrates integrity, commitment, and passion, • Must be currently employed in a logistics sales role, • No non-compete preferred, • Strong verbal and written communication skills, • Proficient with Excel, PowerPoint, and Word Sales CapabilitiesConsultative Selling • Ability to diagnose customer needs and design customized logistics solutions, • Comfortable discussing automation, EDI/API integration, and operational efficiencies, • Proven history of building loyal, portable client relationships, • Can articulate monthly revenue, GP, margins, and industry mix without embellishment, • Clear prospecting strategy (cold calling, cadence, vertical targeting), • Skilled in CRM execution and organized follow-up, • Strong discipline in pipeline management and forecasting Experience Requirements • Minimum 5+ years of successful freight forwarding sales experience, • Ability to demonstrate true account portability and retention, • Must be accurate — no inflated performance claims Benefits • Medical, dental, and vision insurance, • 401(k) with company match, • Life, short-term, and long-term disability coverage, • Paid vacation, sick time, and holidays, • Flexible/remote options for high-performing sales reps, • Competitive base salary + strong commission structure, • Annual performance bonuses, • Company laptop and mobile reimbursement, • Ongoing sales, compliance, and technology training, • Supportive, fast-moving culture with strong operations backing

Job Description Who we are: Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai's portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. Your next role as a Miracle Maker Maravai LifeSciences is seeking a #MiracleMaker to join our Process Development team as a Manager, Production Operations & GMP. As a Manager, Production Operations & GMP you will lead a team of technical subject matter experts and GMP support staff to ensure efficient, compliant, and innovative manufacturing operations. This role provides technical leadership for production processes, supports technology transfers, and drives continuous improvement initiatives. Responsibilities include coaching and mentoring manufacturing teams, sustaining process knowledge, optimizing workflows, and overseeing cleanroom operations and GMP compliance. Acting as a technical liaison, the Manager will collaborate cross-functionally with Manufacturing, Quality, R&D, Supply Chain, and Commercial teams to support new product introductions, customer projects, and investigations. This position requires strong expertise in biologics manufacturing, cleanroom operations, and GMP standards, with the ability to operate semi-independently and deliver solutions in a fast-paced CDMO environment. How you will make an impact: • Lead cGMP CDMO technology transfer projects between customers and internal manufacturing teams for mRNA production., • Manage tech transfer activities for NPIs from R&D/Process Development to GMP manufacturing, ensuring reproducibility and high quality., • Provide technical oversight during technology transfer and manufacturing campaigns; assess and optimize process parameters for scalability., • Design and execute experimental protocols; analyze data and prepare technical reports., • Oversee GMP production and cleaning operations, ensuring compliance with regulatory standards and company requirements., • Review and approve controlled documents, batch records, cleaning documentation, and GMP documentation (SOPs, deviations, CAPAs, change controls)., • Train, schedule, and supervise production and support staff; maintain training matrices and job descriptions., • Coach and mentor manufacturing associates in process understanding, troubleshooting, and project management., • Serve as a technical SME for internal teams and customers, supporting investigations and inquiries., • Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Engineering, and R&D to meet production schedules and resolve issues., • Drive continuous improvement initiatives using Lean Six Sigma and statistical tools; lead root cause analyses for critical investigations., • Stay current with industry trends in modern manufacturing technologies (automation, disposable systems)., • Support audits, change controls, and Quality Risk Management programs., • Ph.D. with 2+ years, M.S. with 4+ years, or B.S. with 6+ years of experience in a scientific field (Biology, Chemistry, Biochemistry, or Engineering)., • Minimum 4–6 years of relevant experience in biotech or pharmaceutical development, including at least 2 years in a supervisory or leadership role., • Strong knowledge of cGMPs, 21 CFR 210/211, 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements., • Experience leading technology transfers, process qualification, and validation., • Familiarity with biologics manufacturing, CDMO operations, and ISO 14644 cleanroom classifications., • Ability to draft and review GMP documentation (SOPs, batch records, deviations, CAPAs, change controls, validations)., • Experience with electronic quality systems and ERP platforms (e.g., NetSuite)., • Excellent written and verbal communication skills with experience supporting strategy development and implementation., • Proven ability to manage and mentor teams, work cross-functionally, and drive strategic initiatives., • Strong collaboration skills and ability to influence across departments., • Lean Manufacturing or Six Sigma experience preferred., • Ability to implement processes that deliver measurable results and adapt best practices in novel technology environments. #LI-Onsite The benefits of being a #MiracleMaker: • You have the potential to change, improve, and save lives around the world., • You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans., • We offer comprehensive medical plans and HSA/FSA options., • Fertility & family planning assistance., • A variety of additional optional benefits and insurance options, including pet insurance., • Retirement contributions. To view more opportunities to become a #MiracleMaker, visit our career site at Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Click here to view Maravai LifeSciences Privacy Notice HIRING SCAM ALERT Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: • Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.), • Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment., • Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment. If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at . If you believe you have been a victim of fraud, you can report this activity at: or .

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our CMC Department as a Clinical Supply Chain Specialist and work as part of a team to drive success. The Clinical Supply Chain Specialist, Clinical Supplies will support the planning, coordination, and execution of global clinical supply activities for company-sponsored clinical trials. This role will partner cross-functionally with Clinical Operations, CMC, Quality, Regulatory, and external vendors to ensure uninterrupted supply of investigational product (IP) to clinical sites while maintaining compliance with GxP, regulatory, and company requirements. The ideal candidate is detail-oriented, highly organized, and experienced in managing clinical supply logistics in a fast-paced pharmaceutical or biotech environment. Essential Responsibilities: • Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability., • Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company., • Support end-to-end clinical supply chain activities including forecasting, planning, packaging, labeling, distribution, returns, and reconciliation of investigational product., • Coordinate with internal stakeholders and external CMOs, depots, and logistics vendors to ensure timely manufacturing and delivery of clinical supplies., • Maintain and track inventory levels at depots and sites; proactively identify and mitigate potential supply risks., • Generate and manage clinical supply forecasts and resupply strategies based on enrollment projections, drug product expiry dates, and study timelines., • Support creation and review of packaging and labeling specifications in alignment with study protocols and regulatory requirements., • Manage Interactive Response Technology (IRT/RTSM) supply settings and ongoing updates in collaboration with Clinical Operations and vendors., • Prepare and review shipment documentation and ensure compliance with import/export and country-specific requirements., • Reconcile clinical supplies, including returns, destructions, and accountability documentation., • Contribute to development and continuous improvement of SOPs, work instructions, and supply chain processes., • Ensure all activities comply with GCP, GMP, and applicable regulatory guidelines., • Maintain accurate documentation and support audits and inspections as needed., • Provide Operational support services to CMC development and manufacturing functions., • Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level., • Maintain all appropriate corporate standards for facility safety and hazardous material management. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Bachelor’s degree in supply chain, life sciences, or related field., • BS with 3+ years of experience or MS with 1.5 years of experience in clinical supply chain, clinical operations, or pharmaceutical logistics., • Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • Working knowledge of GxP requirements and global clinical trial supply practices., • Knowledge of clinical trial material and/or investigational drug product, • Experience coordinating with CMOs, depots, and third-party logistics providers., • Familiarity with IRT/RTSM systems and clinical supply management tools., • Strong organizational skills with the ability to manage multiple studies and priorities simultaneously., • Experience supporting global, multi-site clinical trials (Phase I–III)., • Understanding of temperature-controlled shipping and cold chain management., • Experience with import/export documentation and international shipping regulations., • Must be able to work independently with supervision as needed., • Proficient at working independently as well as in cross-functional team settings, • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Data: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • Recruiters & Staff Agencies: ADARx Pharmaceuticals (ADARx) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to ADARx or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of ADARx and the Company will not owe any referral or other fees with respect thereto., • Compensation: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation: Includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Conditional Offer of Employment: Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

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

Job Description Job Title: QA Consultant (GxP) Location: San Diego, CA (On-site) Position Type: Contract / Consultant Department: Quality Assurance Reports To: Site Quality Head / Director, QA This is for the Poseida location in San Diego, CA. Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed About Us Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need. Position Summary The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions. You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams. Key Responsibilities • Support concurrent activities for legacy Quality systems during QMS integration and system migration phases., • Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems., • Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls., • Operate and support legacy Quality systems during the transition to new platforms., • Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records., • Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA)., • Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records., • Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS)., • Support continuous improvement efforts for events within EDMS and LMS., • Work with document owners to ensure timely periodic review of procedures., • Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools., • Generate and trend quality metrics, communicating findings to leadership., • Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans., • Review and approve paper-based quality documentation and electronic quality records., • Promote a culture of quality, teamwork, and accountability with a patient-first mindset., • Align daily activities with department goals and company values. Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred). Technical Skills: • Strong knowledge of Quality Management Systems in a cGxP manufacturing environment., • Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training., • Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio., • Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word). Competencies:, • Exceptional written and verbal communication skills., • Strong attention to detail and ability to manage multiple projects simultaneously., • Proven ability to work independently and collaboratively in a fast-paced, dynamic environment., • Experience developing training materials and delivering training to employees., • Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents. #TB_PH #ZRHCCompany DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CAFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Job DescriptionCompany Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to , and follow us on X or LinkedIn. The Director, IT Enterprise Applications is responsible for the strategic leadership, implementation, and ongoing optimization of ORIC’s enterprise applications ecosystem. This role ensures that core business systems—spanning ERP, Finance, Procurement, Travel & Expense, Supply Chain, and regulated GxP platforms—are scalable, compliant, and operationally robust as ORIC advances from clinical development into commercialization. This leader brings deep hands-on experience with cloud ERP platforms (preferably NetSuite) and adjacent systems such as Coupa, Expensify, and Navan, along with proven ownership of validated GxP systems, including Veeva Vault, SAS, and DocuSign (Part 11). The role partners closely with Finance, Quality, Supply Chain, Clinical, and Commercial teams to enable compliant growth, strong controls, and data-driven decision‑making. This hybrid role is based out of either our South San Francisco, CA or San Diego, CA office Job Description Enterprise Applications Strategy & Governance • Define and execute a multi-year enterprise applications roadmap aligned with ORIC’s clinical and commercial growth strategy., • Serve as system owner for ERP, procurement, T&E, contract management, and related enterprise platforms., • Establish and enforce application governance, including SDLC, validation, change management, release management, and documentation standards., • Own the end-to-end lifecycle of ORIC’s ERP platform (strong preference for NetSuite), from design and implementation through optimization and support., • Act as system owner for Coupa (Procurement), Expensify, and Navan, ensuring seamless integration with Finance and Operations workflows., • Partner closely with Finance to maintain SOX-compliant IT General Controls (ITGCs), audit readiness, and financial reporting integrity., • Partner with Quality, Regulatory, Clinical, and Medical Affairs to support validated systems and compliant processes., • Oversee IT ownership and support of regulated platforms, including:, • Veeva Vault (Quality Docs, QMS, RIM, etc.), • SAS (clinical and statistical platforms), • DocuSign with 21 CFR Part 11–compliant workflows, • Ensure enterprise systems meet GxP, 21 CFR Part 11, data integrity, and GDPR requirements., • Lead and develop a high-performing enterprise applications team, including internal staff and external consultants., • Own vendor relationships, implementation partners, and Statements of Work (SOWs)., • Drive application portfolio cost optimization, licensing strategy, and ROI., • Establish and track KPIs for system availability, support SLAs, delivery quality, and continuous improvement.Qualifications Required • 12+ years of progressive experience in enterprise applications and IT leadership roles., • Deep hands-on experience implementing and supporting cloud-based ERP systems (NetSuite strongly preferred)., • Demonstrated ownership of GxP‑validated systems and validation initiatives., • Strong understanding of SOX ITGCs, audit processes, and financial systems controls., • Experience integrating supply chain systems and managing 3PL connectivity., • Proven ability to lead complex, cross-functional enterprise system implementations in a regulated environment., • Direct administration experience with:, • Coupa, • Expensify, • Navan, • Commercial‑stage biotech systems exposure (CRM, distribution, chargebacks, gross‑to‑net)., • Familiarity with enterprise integration architectures and iPaaS platforms., • PMP, ITIL, or other relevant certifications. Additional Information The anticipated salary range for candidates who will work on-site at our San Diego location is between $220,000-$240,000 and South San Francisco is between $240,000-$260,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

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

Job 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 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