Formulation & Lyophilization Lead

Use Your Power for Purpose
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.
What You Will Achieve
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

Here Is What You Need (Minimum 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

Bonus Points If You Have (Preferred Requirements):

• 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

PHYSICAL/MENTAL REQUIREMENTS

• 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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• 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.

Work Location Assignment: On Premise
The annual base salary for this position ranges from $116,000.00 to $193,400.00. 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 Act
Pfizer 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.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Research and Development