Director, Drug Product Manufacturing

Drug Product Director – Permanent – New YorkProclinical is seeking a Drug Product Director for an exciting growing biotechnology company based in New York.Primary Responsibilities:In this role, you will serve as a subject matter expert to support regulatory compliance for drug products while aligning all CMC strategies with company goals. You will oversee GMP drug product manufacturing at Contract Manufacturing Organizations (CMOs) to support clinical projects through commercialization. You will have a proven track record in formulation development, process scale-up, technology transfer and commercial manufacturing. You will play a key role in ensuring timely and cost-effective production of high-quality drug products.The position is fully based onsite in New York.Skills & Requirements:Advanced degree (Ph.D./Masters) in Pharmaceutical Science, Chemical Engineering, or related discipline is required with a minimum of 10 years of experience in the pharmaceutical or other related industries. Exceptional candidates without an advanced degree may be considered.Hands-on working experience and in-depth understanding of cGMP requirements and CMC regulatory requirements and related quality requirements for small molecule drug product manufacturing.Proven experience managing CMO relationships and developing outsourcing strategies for manufacturing operations.Extensive background in process development, scale-up, tech transfer, and commercial manufacturing of small molecule drug products.Have experience with IV, Oral formulation development. Experience with successful regulatory submissions (IND and NDA) and interaction with health authorities is highly desirable.Experience with process development and characterization using QbD principles and application of risk assessment tools such as FMEA.Prior experience in technical management of domestic and international CROs/CMOs.Experience in a small company or start-up environment.The Drug Product Director will:Lead the drug product manufacturing strategy for the company, ensuring alignment with product development timelines and corporate objectives.Oversee the scale-up, optimization, technical transfer, and commercialization of small molecule drug products from the clinical through commercial manufacturing phases. Drive continuous improvement in manufacturing processes to enhance efficiency, product quality, and cost-effectiveness. Establish and maintain relationships with Contract Manufacturing Organizations (CMOs) and other external partners to ensure successful outsourcing and contract manufacturing activities.Develop and execute risk mitigation strategies related to drug product manufacturing, including identifying and resolving any manufacturing-related issues. Prepare and review technical documentation, including but not limited to batch records, validation reports, and regulatory filings. Own the drug product modules in the regulatory dossier and collaborate with regulatory affairs to support regulatory submissions and inspections.Incorporate QbD principles and novel technology to process development, as appropriate.If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.