Associate Director, Injectable Drug Product Technology Transfer
On-site · New Haven, Connecticut, United States
Job Summary
Lead the design, execution, and oversight of injectable drug product technology transfers to internal and external GMP manufacturing sites across early-phase development through commercialization. Provide strategic and hands-on leadership in process development, scale-up, manufacturing support, and regulatory submissions. Manage unit operations including freeze/thaw, mixing, sterile filtration, aseptic filling, lyophilization, stoppering, sealing, and visual inspection. Serve as technical SME, authoring and reviewing batch records, validation protocols, deviations, change controls, and regulatory filings (IND, IMPD, BLA, MAA). Monitor process performance, drive CAPAs, and lead investigations. Collaborate with internal and external stakeholders to align timelines and technical strategy; mentor junior staff and contribute to budgeting and departmental strategy. Travel domestically and internationally (~25%) to support manufacturing site activities.
Required Qualifications
- Proven leadership in injectable drug product development and technology transfer, including 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 late-phase development and commercial product launches
- Proficiency with electronic quality systems (e.g., TrackWise) 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
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