AbbVie Director, Cell Therapy, Oncology Early Development CMC Biologics in Redwood City, California
Director, Cell Therapy, Oncology Early Development CMC Biologics
USA, California, Redwood City
Research & Development
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), covalent-inhibitor technologies, and novel cell therapy to discover and develop novel cancer treatments.
We are seeking a Director to join the CMC Biologics group under Oncology Early Development at the AbbVie location in Redwood City, CA. In this role, you will lead the CMC development of AbbVie’s novel Cell Therapy portfolio. We are looking for an energetic individual to drive the strategy for AbbVie’s partnered initiatives with CALIBR (California Institute for Biomedical Research). The new approach using universal CAR-T therapy coupled with switchable technology is expected to have a remarkable impact for oncology patients. You will work closely with Discovery, as well as other CMC functions, and interact with external partners (including CALIBR) to lead cross-functional teams that will enable AbbVie’s new initiative in cell therapy. You will also be actively engaged in developing novel oncolytic viruses and participate in collaborations with external organizations to help build out cell therapy and manufacturing.
Key Responsibilities Include:
Lead a cross-functional team to enable new programs in Cell Therapy.
Develop internal cell therapy capability including required resources, budgets, technology needs to enable programs.
Work with external partners to evaluate and enable partnered cell therapy based programs.
Develop a vendor selection strategy to select services for development and manufacturing of discovery and oncology early development clinical assets.
Plan, track, execute on programs from a pre-clinical stage through clinical proof of concept.
Lead cross-functional team to author CMC/ quality sections of regulatory submissions (INDs/CTDs).
Represent and communicate progress and milestones on cell therapy programs.
Engage and influence the broader scientific community through publications and poster and oral presentations at industry conferences.
BS, MS, or Ph.D. in Bioengineering, Biochemistry, Biology or related field with minimum of 14+ years (Ph.D.).
Must possess significant and demonstrated experience in cell therapy. Experience with traditional biologics a plus.
Experience with CMC development and manufacturing of a cell therapy product either internally or using an outsourcing model is highly desirable.
Proven record of advanced technical/scientific achievement and innovation.
Experience with leading cross-functional teams, project planning, and tracking is required.
Experience with regulatory filings for CMC in the cell therapy / gene therapy area is desirable.
Must have strong written and verbal communications skills.
Must be capable of working in a fast-paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Travel: Yes, 10 % of the Time
Job Type: Experienced