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 subj