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%).