Scientist II - Bioprocess Cell Culture Development

Key Accountabilities/Core Job Responsibilities

• Perform routine tasks such as media/buffer preparation, thawing of cryopreserved cells, cell culture passaging, aseptic sampling and banking competently and independently to support ongoing projects in cell culture lab
• Take routine analytical measurements for cell growth, gas-content analysis, pH, osmolality, nutrient and metabolite measurements and HPLC analysis of monoclonal antibody titers
• Utilize technical expertise and available information to troubleshoot and resolve operational hurdles when encountered and adapt protocols as necessary
• Propose novel scientific experiments in mammalian cell culture
• Collaborate across CMC functions to optimize bioprocess parameters for the production of difficult-to-manufacture biologics
• Execute high-throughput fed batch and batch experiments and perform data analysis of the same
• Able to maintain a can-do attitude to complete innovative projects while being flexible in work priorities based on business needs
• Perform tasks with rigorous attention to detail consistently. Prioritize tasks and contribute to a highly motivated and productive team with a sense of urgency and desire to meet project timelines
• Accurately document, critically analyze/interpret data and communicate the results promptly through various electronic means
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials
• Must be comfortable with physical activities of constant standing, walking, and sitting with arm stretching into biosafety cabinets for cell culture work and occasionally lifting 50Ibs.
• Strong interpersonal skills to thrive in a team environment
• Expected onsite to execute experiments in BSL II laboratory

Qualifications

BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.

• Prior experience in mammalian cell culture techniques, bioreactor operation and cell culture media preparation is a must
• Experience in single use mammalian cell culture tools employed in bioprocess development, including but not limited to deep well plates, shake flasks, wave/rocking machines, ambr250s, stirred tank reactors from bench ( 50L)
• Experience with perfusion technologies and some experience with LIMS deployment/ development is highly desirable
• Excellent aseptic techniques and familiarity with principles of sterilization/disinfection
• Familiar with general troubleshooting techniques and implementation of quality controls in developmental lab
• Experience with process development, optimization, and troubleshooting, especially with translating product quality attributes/ desired product quality profiles to relevant cell culture process conditions
• Experience in the use of spent media analysis to inform media optimization and process development
• Experience in setting up high throughput experiments in both fed batch and batch modes, and comfortable with automation and manual intervention when needed
• Comfortable with practical considerations needed to successfully scale up conditions tested in high throughput systems to larger scales across different sites in the unit operations of cell culture cryopreservation, thaw, expansion, perfusion, fed-batch production and primary recovery
• Experience with the review and analysis of batch records and capable of designing experiments to address gaps between developmental processes and cGMP site capabilities where identified
• Excellent communication skills and experience using collaborative cloud-based technologies
• Knowledge of biological data collection and analysis tools (JMP, GraphPad Prism, HPLCs, Blood gas analyzers, metabolite analyzers) and computer applications such as MS Word, MS Excel and MS PowerPoint
• Able to maintain instrumentation, inventory and cleanliness of a developmental lab to create a safe, effective and efficient scientific working environment