Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)

Role: Lead technical and project activities for testing strategies of biologic/drug/vaccine-device combination products, focusing on design verification and validation from development through commercialization. Responsibilities: define and execute comprehensive testing plans, including test method development, validation, and validation support for drug–device combinations; partner with cross-functional teams and external suppliers to ensure testing aligns with regulatory, quality, and manufacturing needs; author regulatory documentation (INDs, IMPDs, NDAs, BLAs) and support clinical supply testing; stay current with device technologies and standards; lead aging studies, stability testing, and process validation activities. Qualifications: B.S. in Mechanical Engineering or related, with 8+ years (M.S. 5+ years, Ph.D. 3+ years) of experience in combination product development and testing; proven leadership in design verification programs; deep knowledge of device development, design controls, risk management, materials, and manufacturing validation; strong regulatory familiarity with relevant standards (ISO, CFR, FDA guidance). Preferred: experience with device components (plastic, metal, elastomer), sub-assemblies, material characterization, failure analysis, and advanced testing equipment. High-value biopharma specifics: focus on biologics, vaccines, or drug delivery devices across inhalation, implantation, and injection routes; involvement in design verification, validation, and regulatory submissions; collaboration with R&D, manufacturing, and regulatory teams. Work setup: travel ~10%, hybrid or remote options potentially available.