Scientist I, Biologics Drug Substance Development, Cell Culture Development

The Cell Culture Development Group in South San Francisco, CA is seeking a Scientist I to join a talented and collaborative team to develop cell culture processes for GMP applications.

In this position, you will perform cell culture process development, scale-up, and technology transfer activities in a well-supported and dynamic environment to help advance novel biotherapeutics into human clinical studies. 

KEY RESPONSIBILITIES:

 

• Perform inoculum expansion and cell bank generation
• Execute cell culture experiments using Ambr250 and 2L bioreactors
• Perform pilot scale material generation using 50L, 200L and 500L single use bioreactors
• Execute small scale and pilot scale depth filtration and centrifugation primary recovery processes
• Perform tech transfer of Master cell bank generation, cell culture and primary recovery processes to the GMP manufacturing facilities
• Provide person-in-plant support at the GMP manufacturing facility
• Perform cell culture experiments to optimize N-1 perfusion processes as well as intensified fed-batch processes
• Represent the cell culture development group for pipeline projects in cross-functional meetings and collaborate closely with cell line, purification, analytical and formulation development leads to meet project timelines
• Author and review technical reports, GMP campaign summary reports, and relevant sections in regulatory filings
• Proactively identify and implement opportunities to optimize platform processes and deepen process understanding
• Present scientific findings at internal or external conferences

Collaborate effectively with colleagues to promote a positive and efficient laboratory environment, and actively contribute ideas to enhance lab workflows and practices

Required

• Scientific degree in chemical engineering, bioengineering, biotechnology, or a related field. A minimum of 2 years for M.S. or 5 years for B.S. graduates
• Proficient in aseptic techniques
• Experience in developing and executing mammalian suspension cell culture processes in shake flasks, Ambr250 and 2L bioreactors
• Strong understanding of mammalian cell and molecular biology and cell culture bioprocess engineering concepts 
• Strong attention to detail; active and quick learner; able to change courses quickly as needed, raises the bar and is never satisfied with the status quo; opens to suggestions and embraces the ideas of others; actively builds relationships with others
• Experience in technical report authoring and reviewing
• Proficient with Microsoft Office software (Word, Excel, and PowerPoint) and statistical modelling software such as JMP

Preferred: 

• Experience in perfusion technology, especially Alternating Tangential flow filtration (ATF) at bench
• Experience in pilot scale operations including 50L, 200L, 500L Single-use systems, and harvest operations