Associate Director, Manufacturing Package Design
Centessa Pharmaceuticals
August 20, 2026
On-site
Boston, MA
Operations
Key Responsibilities
- Lead the design, development, and technical strategy for primary and secondary packaging components/systems for small molecule solid oral dosage forms supporting late-stage clinical and commercial manufacturing.
- Serve as manufacturing/CMC packaging design lead for external CMOs/CPOs; manage packaging-related technical relationships and conduct site visits as required.
- Partner with CMC and Clinical Supply Chain to align clinical trial packaging/labeling with production forecasts and demand.
- Direct packaging engineering including design verification/validation, transportation/shipping validation, stability packaging configurations, and compatibility studies.
- Lead technology transfer of packaging design/processes from development/clinical to commercial manufacturing (line trials, engineering runs, scale-up).
- Develop/maintain packaging design technical documentation (e.g., design history files, packaging specifications, risk assessments/FMEAs) per cGMP and design control requirements.
- Partner with Regulatory Affairs on CMC packaging sections of submissions and responses to health authority queries.
- Collaborate cross-functionally (Manufacturing, Quality, Supply Chain, Commercial) to support launch readiness and product lifecycle management.
- Implement continuous improvement for packaging processes, equipment, and vendor performance.
- Manage packaging-related change controls, deviations, and CAPAs; support root cause investigations.
- Evaluate/select packaging materials/components/equipment; support supplier and line qualification.
- Provide packaging design expertise for quality systems/procedures; mentor packaging design team.
- Support regulatory inspections/audits related to packaging design/engineering.
- Travel ~10–20%.
Qualifications
- Bachelor’s degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or related field; advanced degree preferred.
- 8–10 years sponsor-side manufacturing package design experience with leadership; significant late-stage clinical and/or commercial packaging program experience.
- Strong cGMP knowledge and pharmaceutical packaging/container closure systems/manufacturing standards.
- Experience leading packaging technical strategy and commercial technology transfer.
- Experience managing CMOs/CPOs and packaging suppliers.
- Working knowledge of drug substance/product and packaging principles across solid dosage and/or parenteral formats.
- Regulatory submission CMC packaging experience preferred; combination product/device packaging experience preferred.
- Strong leadership, project management, and cross-functional collaboration; ability to identify/address packaging issues impacting schedule/supply.
Benefits
- Base salary range: $140,000–$210,000; discretionary annual bonus; 401(k); medical/dental/vision/life insurance; paid time off; health and wellness program.
- Lead the design, development, and technical strategy for primary and secondary packaging components/systems for small molecule solid oral dosage forms supporting late-stage clinical and commercial manufacturing.
- Serve as manufacturing/CMC packaging design lead for external CMOs/CPOs; manage packaging-related technical relationships and conduct site visits as required.
- Partner with CMC and Clinical Supply Chain to align clinical trial packaging/labeling with production forecasts and demand.
- Direct packaging engineering including design verification/validation, transportation/shipping validation, stability packaging configurations, and compatibility studies.
- Lead technology transfer of packaging design/processes from development/clinical to commercial manufacturing (line trials, engineering runs, scale-up).
- Develop/maintain packaging design technical documentation (e.g., design history files, packaging specifications, risk assessments/FMEAs) per cGMP and design control requirements.
- Partner with Regulatory Affairs on CMC packaging sections of submissions and responses to health authority queries.
- Collaborate cross-functionally (Manufacturing, Quality, Supply Chain, Commercial) to support launch readiness and product lifecycle management.
- Implement continuous improvement for packaging processes, equipment, and vendor performance.
- Manage packaging-related change controls, deviations, and CAPAs; support root cause investigations.
- Evaluate/select packaging materials/components/equipment; support supplier and line qualification.
- Provide packaging design expertise for quality systems/procedures; mentor packaging design team.
- Support regulatory inspections/audits related to packaging design/engineering.
- Travel ~10–20%.
Qualifications
- Bachelor’s degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or related field; advanced degree preferred.
- 8–10 years sponsor-side manufacturing package design experience with leadership; significant late-stage clinical and/or commercial packaging program experience.
- Strong cGMP knowledge and pharmaceutical packaging/container closure systems/manufacturing standards.
- Experience leading packaging technical strategy and commercial technology transfer.
- Experience managing CMOs/CPOs and packaging suppliers.
- Working knowledge of drug substance/product and packaging principles across solid dosage and/or parenteral formats.
- Regulatory submission CMC packaging experience preferred; combination product/device packaging experience preferred.
- Strong leadership, project management, and cross-functional collaboration; ability to identify/address packaging issues impacting schedule/supply.
Benefits
- Base salary range: $140,000–$210,000; discretionary annual bonus; 401(k); medical/dental/vision/life insurance; paid time off; health and wellness program.