Vice President of Manufacturing

Cellphire Therapeutics, Inc. is a Rockville, Maryland-based biotechnology company developing next-generation therapeutics. The company is applying its proprietary cell stabilization technology to all cell types, including platelets, to develop lifesaving products. Its lead product, Thrombosomes®, a freeze-dried hemostatic agent derived from human platelets, is currently in a Phase I clinical trial. Cellphire’s technology has potential applications across a wide range of medical applications from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine. Benefits That Matter Competitive base salary + bonus Equity opportunities Comprehensive medical, dental, and vision 401(k) with company match Generous PTO and holidays Position Overview The Vice President of Manufacturing will lead the strategic and operational execution of Cellphire’s manufacturing organization, ensuring scalable, compliant, and cost-effective production of its innovative cell‑based therapeutics. This role is responsible for building and overseeing GMP manufacturing capabilities, advancing process scale‑up, and supporting clinical and commercial readiness. The VP will play a critical leadership role in translating Cellphire’s novel technology into reliable, high‑quality product supply. What You Will Do Lead Cellphire's manufacturing organization, providing strategic direction and operational leadership across process scale‑up, technology transfer, validation, GMP manufacturing, and commercial readiness. Build and expand a world‑class manufacturing organization capable of supporting the company's growth from clinical‑stage development through commercial production while maintaining the highest standards of quality, compliance, and operational excellence. Oversee end‑to‑end manufacturing operations, ensuring reliable product supply, efficient production planning, capacity management, and execution of manufacturing objectives. Develop scalable manufacturing strategies that support current clinical programs while positioning the organization for future commercial demand and long‑term business growth. Build and manage internal manufacturing capabilities while identifying, selecting, and overseeing external manufacturing partners, including CMOs and CDMOs, when appropriate. Partner closely with Quality, Regulatory Affairs, Research & Development, Clinical Operations, Supply Chain, and Executive Leadership to ensure manufacturing activities align with product development timelines, regulatory milestones, and corporate objectives. Ensure manufacturing operations consistently meet FDA, EMA, and global regulatory requirements by maintaining inspection readiness, strong quality systems, and full compliance with current Good Manufacturing Practices (cGMP). Drive operational excellence initiatives focused on improving manufacturing efficiency, production yields, process robustness, cost effectiveness, and overall operational performance. Establish manufacturing metrics and key performance indicators to monitor operational performance, identify opportunities for improvement, and drive data‑based decision making. Develop manufacturing and supply strategies that ensure availability of critical raw materials, qualified suppliers, production capacity, and business continuity. Lead capital planning, operational budgeting, workforce planning, and resource allocation to support organizational growth and evolving manufacturing needs. Recruit, mentor, and develop a high‑performing manufacturing leadership team while fostering a culture of accountability, collaboration, continuous improvement, and employee development. Identify operational risks, proactively implement mitigation strategies, and ensure manufacturing operations are positioned to meet both short‑term deliverables and long‑term company objectives. Serve as a key member of the executive leadership team, contributing to corporate strategy, cross‑functional decision making, and the successful execution of Cellphire's business goals. Ideally, you’ll have PhD, MS, or BS in Chemical Engineering, Biomedical Engineering, Life Sciences, or related field 15+ years of experience in biopharmaceutical manufacturing or operations 8+ years of leadership experience in GMP environments Experience bringing biologics or cell‑based therapies from clinical stage to commercialization Strong understanding of regulatory expectations for biologics manufacturing Proven ability to scale processes and build manufacturing capabilities You’ll excel if you have experience with Cell therapy, blood products, or platelet‑based technologies Lyophilization or freeze‑drying processes Aseptic processing and sterile manufacturing Tech transfer between development and GMP manufacturing environments Working in early‑stage biotech or high‑growth startup environments Interacting directly with regulatory agencies (FDA, EMA) during inspections or filings Pay Range USD $240,000.00 – USD $310,000.00 /Yr. Disclaimer: Please note that job responsibilities, reporting lines, and duties outlined in this job description are subject to change to meet the evolving needs of the organization. Cellphire is an Equal Opportunity Employer. Thrombosomes® has not been approved or licensed by the U.S. Food and Drug Administration (FDA) but has been authorized for emergency use under an Emergency Use Authorization (EUA). The product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use. #J-18808-Ljbffr