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Hold a Ph.D. in a relevant scientific field with over 2 years of experience, an M.S. with a minimum of 4 years, or a B.S. with at least 6 years of experience in the industry specializing in process development and/or cGMP manufacturing.
Possess in-depth knowledge of cell culture processes, including cell banking, thawing and expansion, production, and harvest.
Demonstrated expertise in developing and executing research plans, conducting Design of Experiments (DoE), and validating proof of concept to achieve project objectives.
Proficient in manufacturing products following Standard Operating Procedures (SOPs), batch records, and working within a cGMP regulated environment.
Ability to identify and address technical issues, directing troubleshooting efforts for process and equipment problems.
Duties And Responsibilities
Bioprocessing Research Program Development:
Develop bioprocessing research programs and projects in alignment with organizational goals.
Supervise complex systems, technical personnel, and equipment, optimizing their utilization in bioprocessing and manufacturing processes.
Assist the Chief Scientific Officer (CSO) in conducting bioprocessing and manufacturing activities.
Oversee and mentor upstream scientists and research associates, fostering teamwork and inclusivity within the organization.
Operate and maintain production equipment related to cell culture, focusing on ensuring adherence to cGMP standards.
Manufacturing And Process Optimization
Lead the manufacturing of protein production at both research and clinical scales, overseeing the production of final products.
Collaborate with downstream/purification teams to facilitate the seamless transfer of processes.
Perform various complex tasks following established GMP guidelines, maintaining meticulous records, and assisting in in-process testing.
Provide detailed observations, analyze data, and interpret results to drive process improvements.
Propose, develop, and implement production procedures for enhancing manufacturing processes.
Organize the daily workload schedule and resource allocation for the upstream team, supporting multiple projects simultaneously.
Training And Compliance
Mentor and train production associates on process transfer and scale-up from scientific and engineering standpoints.
Ensure compliance with GMP regulations, including adherence to facility standards, documentation requirements, training protocols, and record-keeping.
Foster effective relationships with internal and external partners, representing departmental activities in various forums as needed.
Uphold the highest ethical and moral standards, following all ServareGMP policies and procedures.
Communicate effectively with senior management, colleagues, and subordinates, providing feedback on personnel performance.
Travel as necessary for professional development, technical training, and to support client project tech transfers.
Employment Type: Full-Time
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology Research
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