AbbVie Principal Research Scientist II - Cell Culture Development in Worcester, Massachusetts
The Cell Culture Development organization within Operations leads the process development and tech transfer of cell culture processes for clinical manufacturing and commercialization of therapeutic proteins in the AbbVie pipeline. In addition, we provide subject matter expertise and experimental support for the manufacture of commercial biologics.
A successful candidate would be one of the senior leaders in the Cell Culture Development group and would be responsible for guiding a team of scientists and engineers in the definition and resolution of complex challenges presented by AbbVie’s robust, diverse biologics pipeline. The candidate would be expected to work together with cell culture scientists at AbbVie Bioresearch Center and other AbbVie sites to define and implement strategies for pre-clinical, early and late stage cell culture development and to identify and prioritize scientific and technological opportunities for investment that will result in robust, high-yielding processes.
• Leads a group of 3+ scientists and engineers with BS/MS and PhDs.
• Leads cell culture process development for monoclonal antibodies, bi-specifics, ADCs, fusion proteins and other molecular formats for early and late stage clinical assets.
• Leads PPQ enabling cell culture process characterization activities.
• Leads/participates in cross-functional CMC teams and reviews relevant sections of regulatory submissions (e.g. IND, BLA, MAA, etc…).
• Advances technical expertise within the cell culture development field. Tracks emerging trends and technologies within the field through internal and external sources, assesses their relevance to AbbVie and facilitates their internal adoption by effectively communicating their value to the business. Pro-actively advises and shares knowledge with the team, peers and senior management.
• Mentors and enhances staff performance to create a climate of excellence to achieve business and scientific objectives.
• Develops, communicates and implements a vision for development of strategic capabilities. Identifies and drives technical innovations that will contribute to future business developments and improvements.
• Builds strong relationships with other process and analytical development teams, Manfacturing Sciences and Technology, R&D, Manufacturing, Quality and Regulatory groups to develop and align strategy to develop AbbVie’s cell culture platform to improve efficiency, productivity, robustness and product quality.
• Takes on a proactive leadership role in the scientific community by showcasing pertinent research at conferences or publishing in scientific journals.
• Outstanding communication abilities for authoring technical reports and regulatory filings, and delivering concise and impactful technical updates to senior leaders.
• BS, MS or PhD in Biology, Biochemistry, Chemical Engineering or related field with 16+(BS), 14+(MS) or 8+ (PhD) years of academic and/or industry related experience. Exceptional candidates with less experience will be considered.
• Outstanding record of accomplishment in the Biotech and/or BioPharmaceutical field
• Proven ability to innovate with a history of capability development and implementation into workflows
• Has demonstrated the ability to lead scientists and engineers through urgent situations by developing actionable goals and robust implementation plans.
• Ability to work effectively in a highly collaborative and changing environment is required.
• Must have a results oriented work ethic and a positive, can-do attitude.
• Excellent written and oral communication skills are expected.
Demonstrated proficiency in bench scale bioreactor, shake flask, and other culture systems for the optimization of cell culture processes.
Experience with automation and miniaturization of cell culture systems to enable high throughput experimentation.
Advanced understanding of data processing and analysis.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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