Job Description

• Actively participates in cell culture production using aseptic techniques and following protocols and procedures.  This includes, but is not limited to: 
• Thaw, maintenance, and expansion of cell culture in shake flasks 
• Freeze of Development Cell Banks 
• Inoculation of bioreactors in a rocker and STR at scales of 2 L – 200 L 
• Maintenance of cell culture by determining cell count, metabolite concentrations, pH, and gassing 
• Designs and executes process development experiments to develop a thorough understanding of operating and performance parameters and identifies promising areas for process improvements.  Effectively analyses experimental results and designs and executes follow-up experiments that build upon previous results. 
• Provides training to new personnel in specific technical processes, as needed.  
• Performs process development activities for projects and products in collaboration with other individuals and departments. 
• Actively participates in technical transfer of upstream manufacturing processes from clients and between Process Development and other internal groups like Cell Line Development and MSAT/MFG. 
• Actively participates in performing scale-up calculations across varying scales of the process — up to cGMP scale. 
• Accurately makes components, media, buffers and other solutions.  
• Assists in the documentation of observations and collecting data for analysis. Participates in data management and the identification of trends in data and the notification of scientists of possible impacts. 
• Provides technical assistance to scientists. 
• Conducts activities in support of production schedules and objectives as directed by senior staff. 
• Maintains records to comply with regulatory requirements and assists with in-process testing.  
• Maintains lab organization and cleanliness by regularly stocking supplies and managing supply inventory. 
• Assembles and autoclaves tubing assemblies. 
• Maintains cleanliness of specific equipment such as incubators, biosafety cabinets, and water baths.  
• Maintains up-to-date knowledge of quantitative and qualitative analytical methods. 
• Represents Process Development and its activities as needed during project team meetings, training, and evaluation of new technologies. 
• As needed, assists with protein production under cGMP standards for production of clinical trial materials. 

Qualifications

• BS or MS degree in biological sciences, biotechnology, biochemistry or related fields with 3+ or 2+ years’ experience, respectively, in the pharmaceutical or biotechnology fields.  
• Strong knowledge of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization. 
• Strong knowledge of cell culture process steps including cell banking, thaw and expansion, production (batch-fed and perfusion), and harvest.  
• Skilled in operating ambr250 and STRs (2 L, 50 L, and 200 L); Sartorius STR experience preferred. 
• Strong knowledge and skill in using equipment for determining cell counts and cell metabolism. 
• Strong knowledge and experience with single-use technologies. 
• Strong knowledge of quantitative and qualitative analytical methods and interpretation of analytical data. 
• Skilled in data management. 
• Skills in problem-solving and troubleshooting. 
• Ability to follow instructions and to maintain accurate records and notes to write detailed development reports.  
• Practical experience of cGMP manufacturing operations and fluency of regulatory regulations is desired. 
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities. 
• Ability to work effectively in a team environment and motivated to work on multiple and various tasks, when required. 
• Skill with Microsoft Office suite.  
• Ability to safely operate production equipment in accordance with established practices.