(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.

Job Responsibilities:

• 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 a.belsabre@proclinical.com.

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.

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