Formulation & Lyophilization Lead
- United States - Kansas - McPherson
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
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 disabilityrecruitment@pfizer.com. 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.
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
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.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Global Supply
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
With an unwavering commitment to ensuring the availability and accessibility of these life-saving medications, we play a pivotal role in reaching patients, healthcare professionals, and markets across the globe.
Our network of state-of-the-art manufacturing facilities, strategically located distribution centers, and streamlined logistics systems enables us to deliver Pfizer's medicines with utmost efficiency and reliability, making a tangible difference in patients' lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)