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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.
Job Responsibility:
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
Contribute to goal setting, performance reviews, and career development for packaging engineers
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
Ensure laboratory notebooks and electronic lab notebook (eLN) systems meet procedural, regulatory, and best-practice standards
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
Partner closely with Quality, Regulatory, EHS, Facilities, Manufacturing, and Global Workplace Solutions
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
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
Requirements:
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
Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, 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
Demonstrated success leading teams and cross-functional initiatives
Excellent written, verbal, and presentation skills
Strong project management and stakeholder engagement capabilities
Combination of laboratory and office-based work
Occasional travel (approximately 5–10%) to other sites, vendors, and conferences
What we offer:
Participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility