About the RoleWe 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 & ComplianceAct 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 & InfluencePartner 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 & ImproveDrive 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.
QualificationsEducation & 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, 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
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
- Occasional travel (approximately 5-10%) to other sites, vendors, and conferences
The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Research and Development
