Principal Scientist Upstream Process Development Lead
| Company | Pfizer |
|---|---|
| Location | New City, NY, USA |
| Salary | $102900 – $171500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Ph.D. degree in Biochemical Engineering/ Cell Biology/Biomedical Engineering/Biochemistry/Chemistry or related discipline with minimum 5 years of industry experience or a MS with 9 years of experience OR BS degree with at least 10 years of industry experience to the position
- A strong background in cell biology, biochemistry, biochemical engineering and cell culture techniques; Hands on experience with development of culture process conditions, assay development and execution and high throughput technology.
- Extensive experience with small-scale and large-scale mammalian cell culture using bioreactor/WAVE for process development.
- Significant experience with DOE and statistical analysis of data.
- Familiar with QbD principle and implementation in process development.
Responsibilities
- Provide leadership to the upstream process development workstream for bacterial and mammalian cell culture team in Vaccines EBPD process group
- Design, plan, schedule, organize, prioritize, execute, document and present complex experiments to optimize and enhance protein production and quality in bacterial and mammalian cell culture, especially in bioreactors using Design of Experiment (DOE)
- Evaluate and incorporate host cell selection, media and feeds to improve cell culture processes for improved product yield and quality
- Streamline cell/bacterial culture process to save time and cost of goods for continuous improvement; Propose solutions to scientific problems and offer insights based on experience to direct reports and other collaborators
- Take a leadership role in technology transfer initiatives via effective inter-departmental interfaces and author tech transfer 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; Collaborate with colleagues within and outside of the Vaccines Early Bioprocess Development organization
- Lead the evaluation and implementation of new technologies to improve cell culture/fermentation capabilities of process development group; Keep abreast of scientific/ technological development by participating in scientific meetings/ seminars and through regular scientific review.
Preferred Qualifications
- Experience with AMBR/Perfusion/iCELLis/continuous processing.
- Significant experience with media development and optimization and familiarity with cell metabolic pathway.
- Big data processing and acumen to identify trends and key parameters.
- 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.
- Working knowledge of Culture Clarification/Harvest and Downstream purification.
- Thorough understanding of protein chemistry; Some experience with protein/antibody purification/characterization.
- Solid understanding of principles of cell line development; Experience in IND/BLA enabling documentation.