Senior Scientist, Upstream Process Development job in Gaithersburg, USA

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Job type: Permanent

Discipline: Biochemistry, Biological Sciences, Molecular Biology

Location: United States

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

Proclinical is currently recruiting for a Senior Scientist, Upstream Process Development for an exciting and rapidly growing biotech company near Gaithersburg, MD. As the Senior Scientist Upstream Process Development, you will be play a leading role on upstream process development; scale up, and technical support of cGMP manufacturing and be responsible for generating materials for pre-clinical studies and other development purposes.

Job Responsibilities:

Design experimental work independently or with minimal supervision.
Perform hands on work in a cell culture lab, specifically cell culture expansion as well as process scale up and implementation into GMP clinical production suites.
Design and execute process development studies to develop a thorough understanding of operating and performance parameters.
Ability to process complex data and communicate clearly and timely the implications of the results.
Perform and analyze Design of Experiment (DOE) studies to develop or optimizing processes to ensure a phase-appropriate, consistent, high-yielding, and scalable upstream process.
Generate, manage, evaluate, and maintain critical data in a highly organized manner.
Assist in scale up and optimization of early-stage processes, support critical operations as needed in our GMP manufacturing facility and deliver materials for pre-clinical and clinical studies.
Provide reagents and other supplies for various projects and departments.
Support process characterization studies and tech transfer process. As needed, support process validation, including validation protocol writing, execution and report writing.

Skills and Requirements:

BS or MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline.
Previous experience with suspension cell culture systems.
Solid and hands-on upstream experience is required.
A previous track record of culture process development experience such as cell passaging, formulation of media, aseptic technique processing, and managing reagents.
Practical demonstration of hands-on process development including use of statistical design of experiments is required.

If you are having difficulty in applying or if you have any questions, please contact Alex Tooulas at (+1) 917-284-9670 or a.tooulas@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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