Senior Scientist II, Cell Culture Development

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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