Formulation & Lyophilization Lead

• Provide direct technical leadership for formulation lyophilization and EDES activities supporting PC1‑AMTF programs and customer commitments.
• Provide indirect people leadership for formulation lyophilization and EDES supporting PC1-AMTF programs and customer commitments.
• Own the full lifecycle management of laboratory and process equipment ensuring systems remain qualified compliant and suitable for intended use.
• Approve and oversee Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) strategies using risk‑based cGMP‑compliant approaches.
• Ensure sustained compliance through effective documentation data analysis change control deviation management and CAPA execution.
• Serve as senior technical escalation point for complex equipment formulation or lyophilization issues impacting timelines or compliance for pre-commercial third-party programs.
• Lead cross‑functional collaboration with Quality Engineering IT Manufacturing and external vendors to deliver validated accurate and reliable laboratory operations.
• Manage resources priorities and continuous improvement initiatives to enhance operational efficiency robustness and regulatory readiness for pre-commercial third-party programs.
• Support project change control assessments

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
• Strong oral and written communication skills
• Proficiency in delivering compelling presentations
• Familiarity with cGMP GLP and GDP procedures
• Keen eye for detail
• Experience in managing people
• Ability to manage multiple projects and ongoing work activities of moderate complexity

• Master's degree (MS/MA/MBA) with 3+ years of experience or a Doctoral Degree (PhD/PharmD/JD).
• Effective communication and negotiation skills with vendors
• Strong mathematical analytical and reasoning abilities
• High degree of creativity and innovation
• Ability to adapt to changing priorities and manage multiple tasks
• Experience using common AI tools including generative technologies such as ChatGPT or Microsoft Copilot to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices including risk management and ethical use

• Ability to work in laboratory.
• Ability to review and analyze complex technical data qualification documentation and compliance records.
• Occasional light lifting and extended periods of sitting or standing are expected. The role may involve bending reaching and working with lab instrumentation and data systems.

• Standard day shift Monday through Friday. Occasional off-shift hours may be required to support urgent project needs.
• Minimal travel (0-10%) may be required. Travel may include attendance to scientific conferences support for new business development or collaboration with external partners.
• Work involves routine exposure to laboratory chemicals and reagents. Strict adherence to safety protocols and PPE usage is mandatory. Occasional work in potent laboratories under controlled conditions. The role operates within regulated environment (GLP cGMP) requiring compliance with Pfizer Quality Standards and industry guidelines.

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors the problem solvers the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

Gallery