The incumbent will lead the Early Bioprocess Development (EBPD) effort in developing state of the art mammalian cell culture processes for production of proteins of interest. The primary purpose of the position is to assure the proper design, planning, and execution of cell culture process development experiments by a group of cell culture scientists. The position requires proven expertise in media optimization, recombinant protein expression and process development. The scope of responsibility includes the development and optimization of mammalian cell culture media and parameters to enhance growth, product yield and quality. Experience with bioreactor/WAVE systems is essential. The position also requires an appreciation of scale up and GMP manufacturing considerations. Careful documentation of work and effective presentation of data is required. A proven leadership track record is required.ROLE RESPONSIBILITIES
QUALIFICATIONS Must Have
- Provide leadership to the Upstream Process Development for mammalian cell culture group in Vaccines EBPD
- Lead the design and execution of experiments to optimize and enhance protein production using mammalian expression platforms
- Evaluate and incorporate media and feeds to improve cell culture processes for improved product yield and quality
- Lead the design of cell culture activities which focus on characterization, scale-up, and demonstration of process robustness
- Perform and analyze Design of Experiment (DOE) studies to fully characterize processes
- Take a leadership role in technology transfer initiatives via effective inter-departmental interfaces and author tech transfer documentation
- Collaborate with colleagues within Vaccine Research and Development organization including Bioprocess Purification, Analytical, and Formulation Development groups
- Establish relationships and collaborative working alliances outside of Vaccines Early Bioprocess development to foster project advancement
- Propose solutions to scientific problems and offer insights based on experience to direct reports and other collaborating scientists
- Plan and prioritize cell culture related activities for the group
- Lead the evaluation and implementation of new technologies to improve cell culture capabilities of process development group
- Streamline cell culture process to save time and cost of goods for continuous improvement
- Coordinate cell culture activity support and serve as a point person for the Process Development group when required.
- Provide leadership in analyzing, interpreting, and packaging experimental data taken from across the cell culture group
- Author and review cell culture procedures and reports, relevant parts in patent application and IND enabling documentation
- Represent the process development group in relevant project sub team meetings. Maintain detailed records of the meetings and keep management informed as to progress or issues.
- Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review.
- Where applicable, perform job responsibilities in compliance with GLP and all other regulatory agency requirements
- Satisfactorily complete all GLP and safety training in compliance with departmental requirements and follow appropriate safety practices in the workplace
- Perform timely notebook entries and review for completed experiments.
- Assure a strong alliance with the EBPD purification group to develop scale down purification models to help rapidly assess clones/strains and culture processes
Nice to Have
- Ph.D. degree in Cell biology or Biochemical Engineering/Biomedical Engineering/Biochemistry/Chemistry/Biology or related discipline with minimum 5 years of related cell biology, biochemistry, and cell culture experience OR an MS/BS degree and a minimum of 10 years ofrelated cell biology, biochemistry and cell culture experience
- Hands on experience with development of culture process conditions, assay development and execution and high throughput technology is required
- Extensive experience with small-scale and large-scale mammalian cell culture bioreactor/WAVE process development equipment.
- Significant experience with DOE and statistical analysis of data is required.
- Working knowledge of Cell Clarification/Harvest and Downstream purification
- Thorough understanding of protein chemistry.
- Solid understanding of principles of cell line development.
- Experience to designing, organizing and executing multiple complex experiments simultaneously
- Experience planning project workflows and keeping track of past records for different projects
- Experience leading/managing a small team
- Significant experience with media development and optimization and familiarity with mammalian metabolic pathway is a plus
- Experience with AMBR/Perfusion/iCELLis/continuous processing is a plus
- Big data processing and acumen to identify trends and key parameters is a plus. Familarity with QbD principle and implement in process development
- Has a solid understanding of cGMP/ICH and regulatory requirements, in particular as they apply to the development of new processes. Familiarity with CMC drug substance process development. Experience with tech transfer and PPQ/CPV is a plus.
- Some experience with protein/antibody purification/characterization is a plus.
- Experience in IND/BLA enabling documentation is a plus
The ability to make aseptic transfers and perform the relevant laboratory functions.
Mental requirements are a detailed understanding of the scientific subject matter, an ability to make scientific judgments and an ability to perform complex data analysis. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Works irregular hours (weekends and outside of 9-5 format) as experiments warrantOTHER JOB DETAILS
Eligible for Relocation Package
Eligible for Employee Referral BonusPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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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.
Research and Development