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POSITION SUMMARY:

The R&D Scientist I - Upstream will be responsible for designing and implementing cell culture process development activities, including but not limited to: growth and feed medium development, shake flask and small-scale bioreactor process development and optimization studies, cell culture process scale-up and technology transfer. The R&D Scientist I - Upstream provides technical guidance and leadership to process development staff.

ESSENTIAL FUNCTIONS:

• Develops, optimizes and characterizes cell culture process for the production of MAbs, gene therapy vectors,  and other biologics. 
• Designs, performs and analyzes small-scale cell culture experiments.
• Develops new cell culture growth and feed media formulations.
• Bioreactor process scale-up to 250 L.
• Transfers processes to the cGMP plant and supports cGMP manufacturing at up to 250L scale.
• Ensures that all work is properly documented and suitable for regulatory submission.
• Drafts technical reports to support technology transfer, regulatory and intellectual property submissions.
• Maintains substantial knowledge of state-of-the-art principles in cell culture technology.
• May manage process development projects and supervise junior process development personnel.
• Works on problems of moderate scope where analysis of situation or data requires a review of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solution. Normally receives general instructions on routine work, detailed instructions on new assignments.
• Perform additional job-related duties as required.

• REQUIRED QUALIFICATIONS:

• Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and a minimum of 0-2 years of relevant experience in cell culture process development and characterization.
• Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
• Must be detailed orientated with the ability to maintain accurate records and excellent proofreading skills.
• Must have excellent time management and organizational skills, to meet deadlines with minimal supervision.
• Experience with typical cell culture equipment and procedures including bench-scale and pilot-scale bioreactors, cell counters, metabolite analyzers, etc.
• Experience in micro- and molecular- biology techniques such as molecular cloning, flow cytometry based assays and recombinant cell line development is a plus.
• Experience with insect cell/baculovirus system is a plus.
• Willingness to work extended and, at times, unusual hours to meet business needs.

• Job may require working with hazardous and infectious materials.   Employees will receive appropriate training and be required to adhere to UMBL policies and procedures.
• Job may require flexibility to work unusual hours during production processes.

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