Process Development Scientist II
Oakland-Fremont-Pleasanton Metro Area, California
The Process Dev Scientist II provides technical expertise to the development, scale-up, transfer, and/or support of production processes for plasma derived or recombinant proteins.
- Activities are centered on unit operations such as:
- cell culture
- phase separation
- process trouble shooting.
- May have supervisory responsibility for up to approximately 6 technicians.
- Independently identifies actions required to support departmental objectives.
- Execute action plans independently, as part of a team, or as the lead for a departmental team.
- Independently prepares and edits procedures or technical reports, including data interpretation, suitable for regulatory submission.
- Prepares and effectively communicates technical results in cross-functional settings.
- Applies scientific principles in development of solutions to complex technical problems.
- Independently designs, executes, and interprets results for scientifically rigorous experiments.
- May direct others in study execution.
- Has considerable knowledge in professional field of specialization and can mentor/train junior staff in relevant principles and/or guidelines.
- Maintains laboratory and clinical manufacturing facilities in accordance with procedure.
- Provides and/or supervises support for developmental studies, clinical or commercial manufacturing as needed.
- Identifies, implements, and qualifies, as necessary, equipment to achieve operational needs in compliance with regulatory expectations.
- Demonstrates ability to apply diverse knowledge base to novel areas.
- Possesses advanced laboratory skills
- Displays organizational skills and ability to prioritize personal tasks to meet deadlines
- Efficiently works in a team-based environment to meet goals
- Demonstrates effective written & oral communication skills
- Proficient with the use of FPLC hardware and Unicorn and MS Office software
- Minimum Bachelors in Microbiology, Biochemistry, Chemistry, Chemical Engineering, or relevant Life Science field
- PhD with 2+ years
- BS with 8+ years
- MS with 4+ years