Upstream Process Development Lead

ROLE SUMMARY

This laboratory-based leadership role will lead upstream process development for both mammalian cell culture andmicrobial fermentation platforms within Vaccines Early Bioprocess Development (EBPD).

The incumbent will provide scientific and people leadership for the design, planning, execution, and interpretation of experiments supporting recombinant protein and vaccine antigen production. The role requires strong expertise in upstream process development, including host and cell-line evaluation, media and feed optimization, bioreactor process development, and integration of product yield and quality considerations.

The successful candidate is expected to bring deep expertise in at least one platform, mammalian cell culture or microbial fermentation, together with demonstrated knowledge of and ability to lead programs across the other platform.

Responsibilities include application of high-throughput and scale-down models, Design of Experiments (DOE), process characterization and modeling, scale-up, technology transfer, and development of processes suitable for good manufacturing practice (GMP) manufacture. Experience with automated and conventional bioreactor systems, such as ambr, stirred-tank bioreactors, and rocking-motion bioreactors, is highly valued.

The role requires rigorous documentation, clear communication of data and recommendations, effective cross-functional collaboration, and a proven record of scientific and team leadership.

ROLE RESPONSIBILITIES

· Provide scientific and people leadership for the upstream process development workstream spanning mammalian cell culture and microbial fermentation within the Vaccines EBPD Process Development group.

· Lead the design, prioritization, execution, documentation, and communication of complex studies to improve cell growth, recombinant protein expression, product yield, and quality across mammalian and microbial production systems, using DOE and mechanistic modeling approaches where appropriate.

· Direct the evaluation and optimization of production hosts or cell lines, inoculum and seed-train strategies, culture media and feeds, and bioreactor operating parameters.

· Apply platform-appropriate strategies to mammalian cell culture and microbial fermentation while identifying opportunities for common workflows, high-throughput experimentation, automation, digital tools, and continuous improvement.

· Provide scientific judgment and coaching to direct reports and collaborators. Translate experimental results into clear process development decisions, risk assessments, and recommendations.

· Lead upstream scale-up and technology-transfer activities through effective cross-functional interfaces. Author or review development reports, process descriptions, and technology-transfer documentation.

· Represent the Process Development group on project subteams and collaborate with colleagues across Vaccines EBPD and partner organizations to align plans, timelines, deliverables, and issue resolution.

· Evaluate and implement new upstream technologies that strengthen mammalian cell culture and microbial fermentation capabilities. Maintain current knowledge through scientific literature, external meetings, and internal technical forums.

Work a flexible schedule, including occasional work outside core hours or on weekends, when required to support time-sensitive experiments.

QUALIFICATIONS

Required:

· PhD in biochemical or chemical engineering, microbiology, cell biology, biotechnology, biochemistry, or a related discipline with at least five years of relevant experience; or an MS/BS with at least 10 years of relevant experience appropriate to the position.

· Demonstrated expertise in upstream bioprocess development, with deep hands-on experience in at least one of the following areas: Mammalian cell culture or Microbial fermentation using automated or high-throughput bioreactor platforms and conventional systems, such as ambr, stirred-tank bioreactors, rocking-motion bioreactors, perfusion systems, or fixed-bed bioreactors.

· The candidate must also have sufficient knowledge and experience to lead development activities across both platforms.

· Hands-on experience developing and optimizing cell culture or fermentation processes in bench-scale bioreactors, including inoculum or seed-train development, media and feed optimization, process-parameter evaluation, sampling, and data interpretation.

· Experience with recombinant protein or vaccine-antigen expression and with assessing the impact of upstream conditions on product yield and quality.

· Demonstrated application of DOE, statistical analysis, mechanistic modeling and data-driven decision making in process development.

· Understandingof scale-up principles and the development of robust processes suitable for GMP manufacturing and technology transfer.

· Proven ability to lead scientists, manage multiple priorities, solve complex technical problems, and communicate conclusions and recommendations effectively to technical and cross-functional audiences.

Preferred:

· Experience across both mammalian cell culture and microbial fermentation, including relevant production hosts such as CHO or other mammalian cells and bacterial or yeast expression systems.

· Experience with Quality by Design (QbD), process characterization, scale-down models, continuous processing, or advanced process monitoring and control.

· Working knowledge of current GMP, ICH guidelines, and regulatory expectations for the development of biological manufacturing processes.

· Familiarity with CMC drug-substance development, technology transfer, process performance qualification, continued process verification, and authoring of investigational new drug application or biologics license application documentation.

· Working knowledge of harvest and clarification operations, downstream purification, protein chemistry, analytical characterization, and cell-line or strain development.

· Experience using large or complex datasets, modeling, automation, or digital tools to identify process trends and critical parameters.

PHYSICAL/MENTAL REQUIREMENTS

Physical Requirements:

• Ability to perform laboratory experiments safely and to stand, sit, walk, bend, and lift during a standard workday.
• Ability to perform aseptic transfers and equipment-related operations, including lifting up to 50 pounds, where required.

Mental requirements:

• Detailed understanding of relevant scientific subject matter.
• Ability to exercise sound scientific judgment, solve complex technical problems, and perform advanced data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The work requires a flexible work schedule to properly perform cell culture manipulations. This may involve the necessity of working outside of core hours and on weekends.

Relocation support available

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 Act

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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.

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Research and Development