Associate Director, Injectable Drug Product Technology Transfer

This role involves leading the development, characterization, technology transfer, and validation of sterile injectable drug products across a range of modalities. The successful candidate will serve as a technical subject matter expert, providing strategic and hands-on leadership in process development, scale-up, manufacturing support, and regulatory submissions.

Key responsibilities include:

• 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.