Senior Scientist, Upstream Process Development

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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