Associate Director, Injectable Drug Product Technology Transfer

Associate Director, Injectable Drug Product Development

The Associate Director will lead the development, characterization, technology transfer, and validation of sterile injectable drug products across a range of modalities including biologics, peptides, nucleic acids, and synthetic molecules. This role spans early-phase development through commercialization and includes responsibility for liquid and lyophilized formulations in vials, prefilled syringes, and cartridges. The successful candidate will serve as a technical subject matter expert (SME), providing strategic and hands-on leadership in process development, scale-up, manufacturing support, and regulatory submissions.

You will be responsible for:

• Leading cross-functional teams in the design, execution, and oversight of injectable drug product technology transfers to internal and external GMP manufacturing sites.
• Developing and implementing robust, phase-appropriate technology transfer and process validation strategies, including risk assessments, FMEAs, and control strategies.
• Overseeing development and optimization of drug product unit operations such as freeze/thaw, mixing, sterile filtration, aseptic filling, lyophilization, stoppering, sealing, and visual inspection.
• Serving as the technical lead during manufacturing campaigns, providing on-site support, troubleshooting, and decision-making in collaboration with Process Development, QA, and Operations.
• Authoring and reviewing technical documentation including batch records, validation protocols, change controls, deviations, and regulatory filings (IND, IMPD, BLA, MAA).
• Monitoring and trending process performance data; leading investigations and implementing CAPAs as needed.
• Collaborating with internal and external stakeholders to ensure alignment on timelines, deliverables, and technical strategy.
• Leading or contributing to continuous improvement initiatives to enhance the efficiency and effectiveness of technology transfer and manufacturing support processes.
• Staying current with industry trends, regulatory expectations, and emerging technologies in injectable drug product development.
• Mentoring junior staff and contributing to resource planning, budgeting, and departmental strategy.
• Traveling domestically and internationally (~25%) to support manufacturing site activities.

You will need to have:

• Proven leadership in injectable drug product development and technology transfer, including experience with biologics and complex modalities.
• Deep technical knowledge of sterile manufacturing processes and equipment, including single-use systems.
• Strong understanding of GMP regulations, process validation, and regulatory submission requirements and supporting regulatory inspections as a technical SME.
• Experience managing or mentoring technical staff and leading cross-functional project teams in direct or matrix teams through late-phase development and commercial product launches.
• Proficiency with electronic quality systems (e.g., Track Wise) and data analysis tools.
• Excellent communication, collaboration, and problem-solving skills.
• Ability to work in GMP environments and travel as needed for manufacturing support.
• Prior work with CDMOs and global manufacturing networks.
• Familiarity with protein formulation, stability, and analytical methods.

• Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or Engineering with 8+ years of experience; M.S. with 12+ years; or B.S. with 15+ years in biopharmaceutical drug product development and manufacturing.
• Lean Six Sigma or continuous improvement training