Senior Manager, External Manufacturing Operations

Senior Manager, External Manufacturing Operations Base pay range: $185,000.00/yr - $195,000.00/yr DIRECT HIRE MUST HAVES: 10+ years of experience w/ a B.S.; 7+ years of experience w/ M.S. or higher MUST HAVE Small Molecule experience (5+ years) MUST HAVE External Manufacturing experience (5+ years) Must have experience working with / managing CDMO or external partner (3+ years) ABOUT THE POSITION We are looking for a Senior Manager of External Manufacturing Operations to lead the management, implementation, and execution of our CMC strategy at CDMOs. If you are a highly motivated and experienced GMP manufacturing professional with a passion for developing and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team. KEY RESPONSIBILITIES Manage operational and technical support of small molecule CDMOs to deliver on late phase clinical and commercial production. Lead CDMOs to implement CMC strategy in manufacturing including but not limited to efforts to optimize manufacturing processes, implement process changes, and reduce manufacturing costs. Provide on-site CDMO oversight, as needed, to accomplish clinical and routine, commercial production goals. Provide SME impact assessments on deviation investigations, support CAPAs, and manage proactive initiatives and change controls, as required. Lead review and approval for technical reports, risk assessments, batch records, SOP’s, etc. required for cGMP manufacturing. Develop, track, and monitor production data for CMO during clinical manufacturing and PPQ to mature to continued process verification (CPV) during commercial manufacturing. Represent External MFG / MSAT on cross functional teams (internal and external) for late stage / commercial CDMO. Act as the internal project team lead for CDMO. Ensure operational robustness and efficiency through management and tracking of manufacturing metrics and KPIs. Support authoring and review of CMC sections of health authority submissions. Provide immediate response support, as required. Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches. Other duties as assigned. QUALIFICATIONS AND EDUCATION B.S, M.S, or Ph.D. degree in chemistry, chemical engineering or related, scientific discipline required. 10+ years of experience w/ a B.S.; 7+ years of experience w/ M.S. or higher. 5+ years of experience, in process chemistry/development, MS&T, and/or External Manufacturing for small molecules required. cGMP manufacturing experience required. 3+ years preferred. Experience managing production at CDMOs required. 3+ years preferred. Experience with late-stage clinical enabling, PPQ and commercialization activities for small molecules preferred. REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES Experience managing manufacturing activities and CDMOs during clinical/commercial cGMP manufacturing. Strong understanding of cGMP regulations and process chemistry. Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners. Experience authoring and reviewing protocols and reports that support GMP manufacturing, validation, and regulatory (BLA/MAA/etc) filings. Strong analytical and problem‑solving skills, with the ability to apply scientific and engineering principles to complex technical problems and data trending. Ability to meet deadlines, adapt to rapid changes, and work in a fast‑paced team environment. Proficient use of MS Office products, JMP or other data analysis software proficiency is a plus. Travel required up to 20% Seniority level Mid‑Senior level Employment type Full‑time Job function Other Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing #J-18808-Ljbffr