Research Associate, Downstream Process Development

Boston, Massachusetts

Our clinical-stage pharmaceutical client here in Boston, MA is building out their Process Development team and looking to add a Research Associate, Downstream PD to their team (onsite 3-4 days/week)! Responsibilities include but not limited to:

• Serve as subject matter expert on chromatography and filtration unit operations.
• Execute process development activities for chromatography (ion exchange, mixed mode, hydrophobic/hydrophilic) and filtration operations (microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration).
• Execute new technology development initiatives for manufacturing process improvement.
• Support manufacturing investigation supporting activities and program lifecycle management activities.
• Implement in-process analytical assays as necessary.
• Collaborate with other functions and support downstream 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 chemical engineering, biochemistry, pharmaceutical sciences or related field; AND 5 years (BS) OR 3 years (MS) relevant industrial experience in bioprocessing.
• Demonstrated technical expertise in purification of recombinant proteins utilizing column chromatography and filtrations techniques.
• Downstream 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%).