Senior Scientist II, Cell Culture Development

DESCRIPTION:

The Biologics CMC Development team at AbbVie has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing biologic therapies such as monoclonal antibodies bi-specifics and novel modalities to human clinical studies and eventual licensure. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20 novel oncology drugs and successfully filed two BLAs.

The Cell Culture Development Group in South San Francisco CA is seeking a Senior Scientist II to join a talented and collaborative team to develop robust phase-appropriate cell culture processes for drug substance GMP production to enable human clinical studies and eventual licensure cell culture. As a senior scientist you will be responsible for all aspects of CMC cell culture program deliverables and help drive drugs substance cell culture development strategy though program lead assignments in cross-functional CMC teams.

This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite highly collaborative lab environment with face-to-face cross-functional interactions between scientists.

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:

• Development optimize and scale-up cell culture processes for biologics candidates to support early- and late-stage development
• Demonstrate the ability to resolve key project or process hurdles by effectively utilizing available information technical expertise cross-functional collaboration and scientific literature
• Design and execute scalable ambr250 2L 50L 200L and 500L single use bioreactors processes
• Design scalable inoculum expansion and master cell bank generation processes
• Design and execute small scale and pilot scale depth filtration and centrifugation primary recovery processes
• Lead the tech transfer of cell culture and primary recovery processes to GMP manufacturing facilities in other locations
• Provide person-in-plant support at the GMP manufacturing facility
• Independently design and execute cell culture process characterization and process validation studies
• Represent the cell culture development group 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 
• Actively seek out opportunities to optimize our platform or enhance our understanding of cell culture processes
• Publish or present scientific findings in peer-reviewed journals internal or external conferences or consortia  
• Display effective organization verbal written communication skills and adherence to good documentation practices

Qualifications :

Basic: 

• Scientific degree in chemical engineering bioengineering biotechnology or a related field with BS or equivalent education and typically 12 years of experience MS or equivalent education and typically 10 years of experience PhD and typically 4 years of experience
• Must have experience in CMC cell culture process development
• Proficient in aseptic technique
• Experienced 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 culture bioprocess engineering concepts 
• Strong attention to detail; active and quick learner; able to change course quickly as needed raises the bar and is never satisfied with the status quo; open to suggestions and embraces the ideas of others; collaborative actively builds relationships with others
• Experienced in authoring peer-reviewed publications technical reports regulatory documents and/or presentations at conferences
• Proficient with Microsoft Office software and strong understanding of statistical modelling software/tools (JMP SIMCA Minitab Design Expert)

Preferred: 

• Expertise in programming (VBA Python Javascript C)
• Expertise in different modelling techniques  
• Experience with late-stage cell culture development
• Demonstrated scientific aptitude through authorship of peer-reviewed publications 
• Strong understanding of statistical analysis and design of experiments (DOE)

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• This is an on-site opportunity located in South SF CA. 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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