Process Development Scientist, CMC
$80,000 - $100,000/Yr
Orca Bio - Menlo Park, CA
posted about 1 month ago
Full-time - Mid Level
Menlo Park, CA
Administrative and Support Services
About the position
The Process Development Scientist at Orca Bio will play a crucial role in advancing the development of next-generation cell therapies aimed at improving survival rates for patients with blood cancer. This position involves leading process characterization and validation experiments, ensuring cell viability, purity, and potency throughout the cell therapy process, and contributing to the documentation necessary for biologics license application (BLA) submissions.
Responsibilities
- Lead process characterization and process validation experiments and wet lab evaluations.
- Ensure cell viability, purity, and potency throughout the process.
- Conduct data analysis and contribute to scientific and technical documentation.
- Assist in data review for scientific integrity.
Requirements
- Doctoral degree in Chemical Engineering, Immunology, Biochemistry, or a related scientific discipline.
- Experience in a lab environment, preferably in process development.
- Strong scientific principles and understanding of biologics/cells.
- Familiarity with process characterization/validation and regulatory requirements.
Nice-to-haves
- Experience with cell therapy processes and selection mechanisms.
- Previous exposure to late-stage process development and CMC.
- Regulatory compliance experience.
- Prior experience with MACS and/or FACS.
Benefits
- Disability insurance
- Health insurance
- Dental insurance
- 401(k)
- Paid time off
- Parental leave
- Vision insurance
