Principal Scientist, Upstream Process Development
Oakland-Fremont-Pleasanton Metro Area, CA
- Successful candidate will provide technical or scientific expertise & leadership in the upstream process development of mammalian cell culture derived recombinant proteins & monoclonal antibodies.
- In addition to upstream process development candidate will lead efforts for developing & optimizing cell culture processes including process parameter optimization, process characterization & scale-up/tech transfer for large scale product production.
- Candidate will also have experience with microbial fermentation based processes & associated process development, technical transfer & support successful implementation of production fermentation processes at commercial scale.
PRIMARY RESPONSIBILITIES FOR ROLE
- Has considerable knowledge in area of protein & monoclonal antibodies production using mammalian host cell systems, experience with microbial based host cell systems for recombinant protein production is a plus.
- Responsible for design & execution of experiments regarding cell culture media screening/development, evaluate feeding strategies, process parameter optimization & scale-up to support large scale production
- Candidate will monitor, explore & evaluate next generation technologies to speed up process development.
- Be responsible for technology transfer to third parties including partners & CMO
- Supports process technology transfer & scale-up to commercial facilities
- Individual will be accountable for scientific data review including data integrity verification, statistical analysis & technical report writing.
- Directly interfaces with other departmental groups (R&D, Quality Assurance, Regulatory Affairs, Supply Chain & Manufacturing)
- Provide technical leadership to staff with focus on verbal & written communications, teamwork & problem solving
- Uses scientific knowledge to make decisions on projects.
- Analyzes data & results and makes recommendations that impact both the science & the business
KNOWLEDGE, SKILLS, & ABILITIES
- Technical/scientific knowledge of biopharmaceutical processes, both process development & manufacturing scales of operation
- Knowledge of process scale-up & scale-down methodologies, including process characterization & design of experiments
- Understanding/experience with wave bag systems & SUBs is essential.
- Familiarity with Finesse Delta V control systems & PI systems is highly desirable.
- Experience in process technology transfer within & between organizations, manufacturing support & troubleshooting
- Writes procedures & technical reports that include data interpretation.
- Extensive working knowledge of cGMP environments
- Skilled in application of standardized root cause analysis, investigation tools & methodologies.
- Proficient with the use of MS Office (Excel, Word, PowerPoint), application software including Unicorn, JMP, Minitab, Design Expert, etc.
- Minimum of 10 yrs. experience in product development, manufacturing science & technology, process engineering within the pharmaceutical industry required
- 7 yrs. experience working in a pharmaceutical manufacturing site
- Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements
- Master s or PhD in science or engineering preferred