Scientist, Biologics Process Development (Upstream)
The Biologics Upstream Process Development and Manufacturing group is responsible for developing recombinant protein production processes, with a great emphasis on product quality, and the subsequent technology transfer to cGMP Manufacturing. Additionally, the upstream group supports the protein expression needs for multiple early stage research programs.
The candidate hired for this position will employ and create new analytical methods, including HPLC based approaches, to track protein quality between microbial fermentations and within microbial fermentation time courses. The candidate will also perform small scale inclusion body extractions, refolding and chromatography to verify the quality of recombinantly expressed proteins. She or he will write development and qualification reports for upstream in-process methods that are to be used in GMP manufacturing. The candidate will participate in technology transfer of upstream processes to partners or CMOs. Additionally, the candidate will review and/or authors the CMC sections of regulatory filing documents. The ideal candidate will demonstrate an understanding in microbial fermentation and an expertise in both protein analytical techniques, including HPLC method development, and small scale purification, to analyze and characterize the quality of the microbial expressed proteins.
Essential Duties and Responsibilities:
- Development of HPLC based and other analytical methods for analysis of fermentation samples
- Small scale primary recovery including homogenization, inclusion bodies isolation, protein refolding, tangential flow filtration and chromatography using AKTA systems
- Integration of protein yield and quality analytical data with fermentation trend data to form hypotheses towards improved processes
- Support of upstream process scale-up, tech transfer, and CMO manufacturing support
- Supports efforts to identify and minimized host cell protein impurities carried thru the protein production process
- Documents results and developed process in Internal Reports, Qualification Reports, and/or Technology transfer documents.
- When necessary, supports CRO/CMO manufacturing through process demonstration, person in plant (PIP) coverage, and troubleshoots manufacturing issues
- Work efficiently, collaboratively, and cross-functionally toward project timelines and goals
- Attention to detail and ability to keep detailed written records in lab notebook
- Independently design, execute, and interpret laboratory experiments to answer scientific questions
- Forward-thinking to lead and contribute to scientific or technical discussions
- Clear and presentations of results and/ or proposed experiments
- Must possess a positive, can-do attitude and demonstrate creative, problem-solving skills
- Flexibility and ability to adapt to quickly changing priorities
- Mentor and train junior scientists
A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted. A minimum of 2 years work experience in a biotechnology/pharmaceutical industry, preferably in a process development, is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Ability to present technical information to both technical and non-technical audiences is required. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is required. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired. Experience with regulatory filings is a plus. Previous management experience is a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.