This is what you will do: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:- Lead cross-functional teams in the design, execution, and oversight of injectable drug product technology transfers to internal and external GMP manufacturing sites.
- Develop and implement robust, phase-appropriate technology transfer and process validation strategies, including risk assessments, FMEAs, and control strategies.
- Oversee development and optimization of drug product unit operations such as freeze/thaw, mixing, sterile filtration, aseptic filling, lyophilization, stoppering, sealing, and visual inspection.
- Serve as the technical lead during manufacturing campaigns, providing on-site support, troubleshooting, and decision-making in collaboration with Process Development, QA, and Operations.
- Author and review technical documentation including batch records, validation protocols, change controls, deviations, and regulatory filings (IND, IMPD, BLA, MAA).
- Monitor and trend process performance data; lead investigations and implement CAPAs as needed.
- Collaborate with internal and external stakeholders to ensure alignment on timelines, deliverables, and technical strategy.
- Lead or contribute to continuous improvement initiatives to enhance the efficiency and effectiveness of technology transfer and manufacturing support processes.
- Stay current with industry trends, regulatory expectations, and emerging technologies in injectable drug product development.
- Mentor junior staff and contribute to resource planning, budgeting, and departmental strategy.
- Travel 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., 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.
Preferred Qualifications:- 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
Date Posted03-Jun-2026
Closing Date23-Jun-2026
