(Senior) Scientist, Upstream Process Development job in Cambridge, USA

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Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Analytical Chemistry, Bioprocessing

Location: United States

This vacancy has now expired. Please see similar roles below...

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 Marta Suazo at (+1) 347-960-4479 or m.suazo@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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Salary

Highly Competitive Salary

Location:

Wrexham, Wales

Proclinical is seeking a Senior Principal Scientist to lead strategic projects in biomanufacturing processes, focusing on API/Drug substance processing.