Principal Packaging Engineer- Drug Product Design & Development

Location: Chesterfield

** About the Role
** We are seeking an accomplished and forward-thinking leader to join our Biotherapeutics Pharmaceutical Research & Development – Drug Product Design & Development (DPDD) organization. In this highly visible role, you will shape the future of packaging and laboratory operations for innovative drug-device combination products, while championing quality, compliance, and continuous improvement.

You will lead and inspire a team of packaging engineers and laboratory professionals, serving as both a technical authority and people leader.

This role offers the opportunity to influence strategy, drive operational excellence, and play a critical part in advancing products from development through commercialization—ultimately impacting patients’ lives worldwide.
** What You’ll Do
*** Lead & Inspire
* Provide strategic direction and day-to-day leadership for laboratory operations supporting drug product and combination product development.
* Mentor, develop, and empower a high-performing team, fostering technical excellence, accountability, and professional growth.
* Contribute to goal setting, performance reviews, and career development for packaging engineers.
** Champion Quality & Compliance
** Act as the subject matter expert for laboratory operations, ensuring compliance with ISO 13485, GMP, and internal quality systems.

Own equipment calibration and qualification activities in alignment with the Quality Management System.

Ensure laboratory notebooks and electronic lab notebook (eLN) systems meet procedural, regulatory, and best-practice standards.

Drive Technical Excellence Oversee and review testing activities, protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products.

Lead component and container closure system selection, qualification, and development activities.

Author and support regulatory submission content and respond to packaging-related regulatory inquiries.
** Collaborate & Influence
** Partner closely with Quality, Regulatory, EHS, Facilities, Manufacturing, and Global Workplace Solutions to ensure alignment and proactive issue resolution.

Lead cross-functional initiatives to harmonize laboratory and business processes across teams and sites.

Support the transfer of new drug products to commercial manufacturing and post-launch support teams.
** Innovate & Improve
** Drive continuous improvement initiatives to enhance efficiency, quality, and scalability of lab and design control processes.

Identify and implement best practices, tools, and strategies that strengthen DPDD capabilities and future readiness.##
** Who You Are
*** A confident technical leader with deep expertise in parenteral packaging and medical device/combination product development.
* Comfortable working independently while influencing across complex, global, matrixed organizations.
* Known for attention to detail, strong judgment, and ability to balance multiple priorities.
* A collaborative communicator who can translate complex technical concepts into clear, actionable guidance.
** Qualifications
* *** Education & Experience
*** Bachelor’s degree in Engineering or Science (Packaging, Mechanical, Materials, Biomedical, Chemical, Chemistry, Biochemistry, or related) with 12+ years of relevant experience
* OR Master’s/MBA with 10+ years of experience
* OR PhD with 8+ years of experience in pharmaceutical packaging
* development
* * Technical Expertise
*** Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, Zebra Sci, Computrac, plunger movement chambers)
* Experience in GMP and/or ISO 13485 environments
* In-depth understanding of global regulatory and quality standards (FDA, ICH, ISO 13485, 11040, 10993, USP/EP/JP compendia, combination product regulations)
* Ability to interface with regulatory agencies and provide sound technical justifications
** Leadership & Communication
*** Demonstrated success leading teams and cross-functional initiatives
* Excellent written, verbal, and presentation skills
* Strong project management and stakeholder engagement capabilities
** Work Environment & Travel
*** Combination of laboratory and office-based work
*…