Senior Scientist, Manufacturing Science and Technology

Proclinical is currently recruiting for a Senior MS&T Scientist with a leading biopharmaceutical company located in Gaithersburg, MD. As the Senior MS&T Scientist, you will be a key contributor to scale up, tech transfer and GMP manufacturing support activities across the company's highly innovative portfolio. In addition, you would be responsible for ensuring that scientifically sound and scalable Upstream/Downstream processes are created (dependent on your background) whilst also being responsible for generating materials for pre-clinical studies and other development purposes.

Job Responsibilities:

• Transfer and implementation of process, ensuring they are robust, high purity & yield, and scalable for clinical manufacturing of biologic product candidates.
• Perform and analyze Design of Experiment (DOE) studies to develop or optimizing processes.
• Develop and implement process validation strategy including validation protocol writing, execution and report writing.
• Supporting scale up and optimization processes, as well as critical operations in the company's GMP manufacturing facility in order to deliver materials for pre-clinical and clinical studies.
• Provide reagents and other supplies for various projects and departments.
• Collaborate with cross functional teams, including; Process & Analytical Development, Discovery, Manufacturing, and QA teams.

Skills and Requirements:

• PhD or MS degree with relevant industrial experience in Biochemistry, Microbiology, Biology, or closely related field.
• Biologic manufacturing experience is required. Multi-year industrial purification experience with approved biologics is preferred.
• Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.
• Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.
• Strong understanding of FDA regulatory requirements

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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