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Research Associate, Upstream Process Development
3 months ago
Research Associate, Upstream Process Development
Boston, Massachusetts
Our clinical stage pharmaceutical client here in Boston, MA is growing their Process Development team and looking to add a Research Associate, Upstream PD (onsite 3-4 days/week) Responsibilities include but not limited to:
- Serve as subject matter expert on fermentation and/or cell culture unit operations.
- Execute process development activities from vial thaw to shake flasks and bioreactors with aseptic operation.
- Execute new technology development initiatives to enhance manufacturing capabilities (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
- Support manufacturing investigation supporting activities and program lifecycle management activities.
- Implement in-process analytical assays as necessary.
- Collaborate with other functions and support upstream team members as necessary.
- Collect and control experimental data and maintains accurate daily logs of experiments including methods, results, and conclusions.
- Ensure high-quality, timely documentation in electronic laboratory notebooks, technical reports and contribute to regulatory filings.
Requirements:
- Bachelor or master in cell biology, biochemistry, pharmaceutical sciences or related field. AND 5+ years (BS) OR 3+ years (MS) relevant industrial experience in bioprocessing.
- Demonstrated technical expertise in fermentation/cell culture of recombinant proteins.
- Upstream processing experience at small scale, pilot scale and manufacturing scale.
- Understanding of analytical methods used to support process development is needed.
- Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, and manufacturing.
- Direct experience with recombinant VLPs or vaccines is highly desirable.
- Some experience working with CDMOs is nice to have.
- Proficiency in statistical software (JMP, R, etc.) for data analysis and tracking and trending.
Other:
- Seeking Boston local candidates to be on-site 3-4 days per week.
- Willingness to travel to various meetings or CMO sites, including overnight trips (up to 10%).
