We are partnered with an exciting Biotech company based in the San Francisco Bay Area on an Associate Scientist, Downstream Process Development. This is a full-time opportunity.
Responsibilities:
- Develop and optimize multi-step purification processes for drug substances.
- Design and conduct formulation studies for drug substances.
- Present experimental findings during project and team meetings.
- Prepare and author detailed technical reports.
- Implement innovative purification technologies to enhance and streamline processes.
- Transfer purification processes to Contract Manufacturing Organizations (CMOs) for GMP manufacturing and provide oversight.
- Review batch records from CMO manufacturing to ensure compliance.
- Produce materials for in-house development projects.
Education and Experience:
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, or a related scientific discipline.
- Minimum of 4 years of relevant industry experience for Master’s degree holders; 6 years for Bachelor’s degree holders.
Core Competencies and Skills:
- Proficient in protein purification techniques, including column chromatography, standard membrane filtration, and Ultrafiltration/Diafiltration.
- Familiarity with AKTA systems and Unicorn software programming.
- Strong analytical skills for interpreting complex process data.
- Ability to work independently and proactively with minimal supervision.
- Excellent interpersonal, oral, and written communication skills.
- Willingness to travel for Person-in-Plant oversight at CMOs is preferred.
- Experience collaborating with external manufacturing vendors and partners is a plus.