Senior Principal Engineer, Primary Container, Biologics

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We are searching for the best talent for Senior Principal Engineer, Primary Container, Biologics to join our team in Malvern, PA.

Purpose: The Senior Principal Engineer Primary Container, Biologics, will lead the development, selection, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and emerging container technologies for new biologic drug products. The role ensures all primary containers comply with global regulatory, technical, and quality standards while driving innovation and operational excellence.

You will be responsible for:

Strategic Leadership & Governance

• Define and implement the global strategy for primary containers supporting biologics across the JJIM portfolio.
• Oversee development, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and new container technologies.
• Ensure compliance with global regulatory requirements and internal quality standards.
• Partner with cross-functional teams (R&D, Quality, Regulatory, Supply Chain) to align container solutions with product needs.
• Lead risk assessments and mitigation strategies for container systems.
• Manage vendor relationships and evaluate new technologies to enhance performance and patient safety.
• Provide technical leadership and subject matter expertise for regulatory submissions and inspections.
• Drive innovation and the implementation of new technologies across biologics packaging.
• Drive continuous improvement and innovation in container technologies.
• Manage a technical team to deliver a portfolio of projects.

Technical Expertise & Development

• Oversee the design, evaluation, and qualification of primary container systems including vials, pre-filled syringes, cartridges, stoppers, and seals.
• Provide scientific leadership on container–closure integrity (CCI), extractables and leachables (E&L), materials compatibility, and device-drug interface requirements.
• Ensure container strategies support formulation stability, manufacturability, and patient usability.

Project & Portfolio Management

• Partner across CMC, Formulation, Device Engineering, Quality, and Manufacturing to drive product development programs.
• Manage timelines, resources, and budgets for container-related activities.
• Lead risk assessments, mitigation strategies, and governance reviews.
• Manage a technical team, delegate tasks and escalate challenges in a timely manner.

Regulatory & Compliance

• Ensure compliance with global regulatory expectations (FDA, EMA, ICH, ISO, USP/EP/JP).
• Author and review regulatory documentation for IND, IMPD, BLA, and NDA submissions.
• Serve as SME during regulatory inspections and health authority interactions.

Qualifications/Requirements:

Education:

Minimum of a Bachelor's Degree in Packaging Engineering, Material Science, Mechanical Engineering, Chemical Engineering, or a related field is required.

Skills/Experience:

• Minimum of 10 years of experience in biologics drug product development, packaging science, or container–closure engineering.
• Proven leadership experience in pharmaceutical or biotech environments.
• Demonstrated experience with commercial biologics and regulatory submissions.

Technical Skills:

• Expertise in CCI testing, extractables/leachables, materials compatibility, and aseptic processing.
• Strong understanding of combination product regulations and CMC expectations.
• Specific expertise in pre-filled syringe systems is preferred.
• Strong leadership, team-building, and cross-functional collaboration skills.
• Excellent communication and strategic problem‑solving abilities.
• Ability to manage complex portfolios with multiple competing priorities.