Formulation & Lyophilization Lead
About The Position
At Pfizer, our mission is to deliver breakthroughs that transform patients' lives. You will play a crucial role in improving patients' lives by advancing biotechnologically derived products to the market through innovation and delivery of cutting-edge analytical testing. You will be part of a team focused on developing methods and strategies to support product and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, and therapeutic proteins at all stages of clinical development. Your work will help expedite the delivery of top-tier medicines to patients globally, leveraging innovative design and process development skills. In this role, you will: 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
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
