Packaging Design Lead – Manufacturing & Strategy

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Boston (MA)

On-site

USD 180,000 - 240,000

Full time

9 days ago

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Job summary

Centessa Pharmaceuticals is seeking an Associate Director of Manufacturing Package Design to lead the strategy for primary and secondary packaging for late-stage and commercial drug products. You will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, and oversee packaging design, qualification, and launch readiness.

The role requires driving design verification/validation, technology transfer, and risk assessment activities per cGMP and design

Responsibilities

  • Lead packaging design strategy for primary and secondary packaging for late-stage programs.
  • Represent packaging on project teams with external CMOs/CPOs; manage packaging-related relationships.
  • Ensure clinical trial packaging and labeling align with production forecasts and demand.
  • Direct packaging engineering activities including design verification/validation and stability studies.
  • Lead technology transfer from development to commercial manufacturing, including line trials and scale‑up.
  • Maintain design history files, packaging specs, risk assessments/FMEAs per design control.
  • Collaborate with Regulatory Affairs to support CMC packaging sections in regulatory submissions.
  • Support launch readiness and supply continuity across manufacturing and commercial teams.
  • Drive continuous improvement of packaging processes, equipment, and vendor performance.
  • Manage change controls, deviations, and CAPAs related to packaging design.
  • Evaluate packaging materials and equipment with CMOs/CPOs; support supplier qualification.
  • Provide SMEs during regulatory inspections and audits for packaging.
  • Domestic and international travel required (approximately 10–20%).

Skills

Packaging design
cGMP
Regulatory submissions
Project leadership
Vendor management
Technology transfer
Design verification/validation
FMEAs
CAPAs
Documentation (QMS)

Job description

Centessa Pharmaceuticals is seeking an Associate Director of Manufacturing Package Design to lead the strategy for primary and secondary packaging for late-stage and commercial drug products. You will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, and oversee packaging design, qualification, and launch readiness.

The role requires driving design verification/validation, technology transfer, and risk assessment activities per cGMP and design

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