(Senior) Scientist, Upstream Process Development
Proclinical is urgently recruiting for a (Senior) Scientist of Upstream Process Development for a leading clinical-stage biopharmaceutical company located in Cambridge, MA. The company is seeking a talented, creative, and motivated upstream scientist/biochemical engineer to help advance the manufacturing of first in class biologics therapeutics by developing and refining cell culture bioprocessing platforms.
- Independently design and execute cell culture experiments related to development, scale-up and characterization of cell culture processes
- Apply engineering principles in scaling up from bench to pilot and cGMP clinical manufacturing scale
- Establish linkage between upstream bioreactor process parameters and /or media conditions to exosome yield and quality attributes
- Maintain good communication and collaborate with Downstream, Analytics and Research groups to deepen process knowledge and structure-activity relationships;
- Resolve technical problems by applying keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.
- Manage and maintain process data in an organized manner, this includes writing/revising SOPs, authoring technical reports, tech transfer documents and preparing scientific presentations as needed.
- Participate and drive decision-making within the project team by actively engaging in and leading scientific and technical discussions;
- Author scientific manuscripts and patents. Present work internally and externally;
- Ensure effective, high-quality, timely and appropriate documentation in electronic lab notebooks.
Skills and Requirements:
- Advance degree in biochemistry, biochemical engineering or related scientific discipline with an appropriate amount of relevant industry experience (PhD 2+ years, MS 8+ years)
- Advanced knowledge of scientific principles, mammalian cell culture research, and implementation strategies
- Hands on experience with bioreactors (bench and pilot/production scale) is required.
- Experience in development and transfer of production processes for biologics, with specific expertise desirable with antibodies, viral vectors or nanoparticles to cGMP manufacturing organizations;
- With minimal supervision, demonstrated capability to troubleshoot, design/execute thoughtful experiments, and implement innovative solutions.
- Strong work ethic with capability to work independently and in a collaborative environment;
- Excellent communication and presentation skills (oral and written)
- Prior experience in supporting regulatory filings for drug substance manufacturing is a plus
If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 617-903-7746 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.