Principal Scientist Upstream Process Development Lead
What You Will Achieve
This is a laboratory-based role in which the incumbent will lead development of state-of-the-art mammalian cell culture and bacterial fermentation processes for production of proteins of interest in the Vaccines Early Bioprocess Development (EBPD). The primary purpose of the position is to assure the proper design, planning, and execution of cell/bacterial culture process development experiments by a group of scientists. The position requires proven expertise in media optimization, recombinant protein expression and upstream process development. The scope of responsibility includes the development and optimization of media and upstream process in bioreactors to enhance growth, product yield and quality. Experience with AMBR250/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.
How You Will Achieve It
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
Qualifications:
Must Have
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
Nice to Have
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
PHYSICAL/MENTAL REQUIREMENTS
Performing experiments in the lab safely with ability to stand, sit, lift, walk, bend during a standard 8-hour workday.
Being able to make aseptic transfers with ability to lift up to 50lbs and perform the relevant operations with equipment.
Mental requirements:
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
May works irregular hours (weekends and outside of 9-5 format) as experiments warrant
Other Job Details
Relocation support available
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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.
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Join Pfizer as a Principal Scientist Upstream Process Development Lead based in Pearl River, New York, and take on an exciting laboratory-based leadership role. Your expertise will spearhead the development of cutting-edge mammalian cell culture and bacterial fermentation processes for producing proteins vital to our vaccine initiatives. As a vital member of our Vaccines Early Bioprocess Development team, you'll design, plan, and execute experiments aimed at optimizing cell cultures and enhancing product yield and quality. Your experience with media optimization and process development in bioreactors, particularly with AMBR250 and WAVE systems, will shine as you motivate a team of talented scientists. You’ll evaluate and select host cells, refine media and feeds, and lead the technology transfer initiatives, ensuring seamless collaboration across departments. Your passion for innovation and knowledge of scale-up and GMP considerations will propel our projects forward as you document your findings meticulously and present data effectively. We’re looking for someone who thrives in a fast-paced environment with a strong foundation in cell biology, biochemical engineering, and comprehensive process understanding. Embrace this opportunity to make a significant impact in bioprocess development at Pfizer!
Breakthroughs that change patients' lives.
78 jobs
Subscribe to Rise newsletter
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
Sign up for our weekly
newsletter of fresh jobs
