Scientist, Cell Culture and Fermentation in Gaithersburg, MD

Summary of the group:

Members of the tech transfer function are responsible for transfer of upstream processes, from process development into clinical and commercial manufacturing. This team works with process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to GMP manufacturing production.

Main Duties & Responsibilities:

• Routinely transfer multiple projects as upstream tech transfer representative. This includes: Fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and presentations to cross-functional teams and management
• Build and maintains collaboration with partner groups
• Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers
• Effectively communicate and collaborate in a matrix team setting to implement technical solutions
• Write technical reports and deliver presentations
• Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities

Education & Experience Requirements:

• A Bachelors or Masters degree in an engineering or scientific discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.
• Relevant industry related experience (B.S. 5-8, M.S. 2-5).

Required Skills:

• Cell culture tech transfer and/or development experience
• Hands on experience with bioreactors (bench, pilot, or production scale)
• Fundamental understanding of upstream unit operations such as mixing, inoculum expansion, bioreactor, centrifugation, and filtration.
• Knowledge of GMP manufacturing principles and documentation
• Excellent written and verbal communication skills
• Experience with data and statistical analysis

Desired Skills:

• Experience with primary clarification via continuous centrifuge
• Identify and tackle complex manufacturing or bioprocess technical problems with limited data in a timely manner
• Proven track record to defend a technical position
• Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
• Fermentation or viral based production experience
• Skilled in conducting process transfer/process development/technology development projects

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