Scientist - Analytical Operations - II*
Location: Oceanside, CA – onsite 5 days/week. Duration: 1 year.
About the role
Execute purification process development and process characterization studies supporting pivotal and commercial biologics development. Design and perform laboratory experiments for purification process development, scale-up, and technology evaluation. Support process transfer and implementation at internal and external GMP manufacturing facilities. Analyze experimental data and prepare protocols, technical reports, and electronic laboratory notebook documentation. Provide technical support for manufacturing atypical event investigations. Support purification platform development, process improvements, and implementation of new purification technologies. Maintain purification laboratory operations and support GMP/non-GMP drug substance manufacturing activities.
Requirements
- M.S. in Chemical Engineering, Biochemistry, Bioengineering, Biotechnology, or related scientific discipline with 2+ years of relevant experience
- B.S. in a relevant scientific discipline with 4+ years of relevant experience
Skills
Required
- Biologics purification process development
- Purification process characterization
- Chromatography
- Tangential Flow Filtration (TFF)
- Normal Flow Filtration (NFF)
- Centrifugation
- High-throughput purification screening
- Virus inactivation and removal
- Process scale-up
- GMP process transfer and implementation
- Purification process operations
- Experimental design and data analysis
- Electronic Laboratory Notebooks (ELN)
- GMP and non-GMP drug substance processing
Preferred
- AKTA chromatography systems
- UNICORN software
- JMP
- Spotfire
- Design of Experiments (DOE)
- Lab automation
- Data management and data science
- Knowledge management
- Pivotal-stage purification development
- Purification process implementation in GMP facilities
- Purification platform development and technology evaluation
Pay
$45.28/hour