Senior Packaging Design Lead - Late-Stage Pharma

Centessa Pharmaceuticals

Boston (MA)

On-site

USD 140,000 - 210,000

Full time

24 hours ago
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Benefits offered by this job

401(k) plan
Medical insurance
Dental insurance
Vision insurance
Life insurance
Paid time off
Health and wellness program

Job summary

Centessa Pharmaceuticals seeks a Senior Advisor, Manufacturing Package Design to lead the design, development, and strategic packaging efforts for late-stage and commercial drug products. You will guide primary and secondary packaging, drive technology transfer, and manage packaging programs with CMOs/CPOs to ensure launch readiness.

You will partner with CMC, Regulatory, Quality, and Supply Chain to align packaging with forecasts, validation plans, and regulatory submissions.

Qualifications

  • 8-10 years’ experience in sponsor-side manufacturing package design with leadership of packaging programs.
  • Strong knowledge of cGMP regulations and industry standards for pharmaceutical packaging design.
  • Experience leading packaging strategy and design for late-stage/commercial programs, including technology transfer.
  • Experience managing relationships with CMOs/CPOs and packaging component/material suppliers.
  • Working knowledge of drug substance, drug product, and packaging principles across solid dosage and/or parenteral formats.
  • Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred.
  • Experience with combination products/device packaging preferred.
  • Strong leadership, project management, and cross-functional collaboration skills.
  • Ability to address packaging-related technical or quality issues affecting schedule or supply.

Responsibilities

  • Lead design, development, and technical strategy for primary and secondary packaging for late-stage clinical and commercial programs.
  • Represent packaging design on project teams with CMOs/CPOs; manage packaging-related relationships and site visits.
  • Ensure clinical trial packaging and labeling align with production forecasts and demand.
  • Direct packaging engineering activities including 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, and risk assessments per cGMP and design controls.
  • Collaborate with Regulatory to support CMC packaging sections in submissions.
  • Support launch readiness and supply continuity across manufacturing, quality, and supply chain teams.
  • Identify and implement continuous improvement for packaging processes, equipment, and vendor performance.
  • Manage packaging-related change controls, deviations, and CAPAs with Quality; support root-cause investigations.
  • Evaluate packaging materials and equipment with CMOs/CPOs; support supplier qualification.
  • Provide packaging design expertise for quality systems and procedures.
  • Build and mentor a team; support regulatory inspections and audits; travel 10–20%.

Skills

Packaging design
Project leadership
Cross-functional collaboration
CMO management
Technology transfer
Quality systems
Design verification/validation

Education

Bachelor's degree in packaging engineering or related field

Job description

Centessa Pharmaceuticals seeks a Senior Advisor, Manufacturing Package Design to lead the design, development, and strategic packaging efforts for late-stage and commercial drug products. You will guide primary and secondary packaging, drive technology transfer, and manage packaging programs with CMOs/CPOs to ensure launch readiness.

You will partner with CMC, Regulatory, Quality, and Supply Chain to align packaging with forecasts, validation plans, and regulatory submissions.

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