Primary Container Engineer

A large pharmaceutical client in Malvern, PA is seeking a Primary Containter or Packaging Engineer supporting the development of primary containers for New Molecular Entities (NMEs), within large molecule biologics and cell therapy. This role is critical in selecting and developing packaging solutions that ensure drug product safety, stability, and regulatory compliance from early clinical stages through commercialization. This role is majority protocol documentation and compliance focused, with 10% of time spent in the lab helping to fill, label, inspect samples, and complete distribution studies.

Key Responsibilities:
• Evaluate and select appropriate primary containers (e.g., glass vials, prefilled syringes, cold chain formats) for NMEs based on safety and stability requirements.
• Collaborate with cross-functional teams including Drug Product Development (DPD), Device, Clinical Supply, MSAT, Commercialization, and Contract Manufacturing Organizations (CMOs).
• Author and execute protocols and reports using systems like TrueVault; coordinate testing and analyze results.
• Understand and apply GMP, regulatory, and compendial requirements across R&D and commercial launch phases.
• Support documentation for regulatory submissions, including protocol writing and study referencing.
• Work independently with minimal oversight; take on leadership responsibilities based on experience and initiative.
• Engage in investigation work, launch team meetings, and purchase order coordination.
• Contribute to the development of new container solutions when existing formats are insufficient

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-2–3 years of experience in packaging development or primary container engineering
-Experience writing and executing protocols
-Technical knowledge of containers (e.g., glass vials, prefilled syringes, cold chain formats)
-Coordinate getting samples shipped out
-Strong understanding of drug product-container compatibility, especially for large molecules.
-Excellent communication skills and ability to work cross-functionally.
-Technically sound and capable of functioning independently.
-Bachelor’s or Master’s degree in Packaging, Material Science, Mechanical Engineering, Chemical Engineering or a related field

-Experience with similar pharmaceutical companies
-Familiarity with CAR T cell therapy and biologics/ large molecule container development

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.