Position Responsibilities

• Perform all functions associated with mammalian cell culture and process characterization, e.g. technical writing, lab skills suitable for upstream (solution preparation, aseptic technique, cell counting and subculturing, set up and operation of lab scale bioreactors and other cell culture equipment, harvest of bioreactors including centrifugation and filtration), process monitoring, data entry, data analysis and data presentation
• Perform all functions associated with process transfer and scale up to manufacturing, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, assists in equipment commissioning and validation activities
• Mentor and supervise junior team members
• Interface with customer technical and quality representatives, represent MSAT group in Project Teams
• Evaluate proposals from new customers
• Keep current with advances in technology in fermentation and upstream processing
• Some non-standard work hours, e.g. evening or weekend work will be required, up to 10% travel to customer or Lonza sites may be required

Qualifications
Qualifications and Experience

• Ph.D. degree in Biological Sciences plus 5 years’ biotech industry experience in cell culture process development, or
• M.S. degree in Biological Sciences plus 8 years’ biotech industry experience in cell culture process development, or
• B.S. degree in Biological Sciences plus 12 years’ biotech industry experience in cell culture process development
• Advanced knowledge of laboratory and large scale manufacturing ( mammalian preferred), current Good Manufacturing Practices, US / EU regulations
• Advanced knowledge of cell biology, cell culture including small scale bioreactors, scale up and mass transfer, disc stack centrifugation, filtration, statistical data analysis
• Excellent communication skills, technical writing skills, interpersonal skills, ability to work in a fast paced environment