Associate Director / Director, Analytical and Formulation 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), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location.
AbbVie Stemcentrx is embracing new paradigms and technologies to develop novel and life-changing therapies for cancer. As part of a talented and multi-disciplinary team advancing an exciting approach to drug development, we are seeking a highly motivated candidate to join our Process Sciences leadership team. The primary responsibility of this role is to lead the Analytical/Formulation Development group within the Process Sciences organization.
The successful candidate will lead the development of analytical methods and formulations for biologics (e.g. ADC and their associated intermediates) including responsibility for Mass Spectrometry development. The candidate will be accountable for ensuring analytical test methods and control systems meet internal and external Quality and Regulatory requirements for early phase clinical programs, and will ensure state of the art analytical methodologies and strategies are implemented as necessary to support fast first-to-human next-generation ADC programs.
This individual will also play a key role in early research/discovery efforts as programs transition from research into development, and will also contribute to the transfer of late-stage programs to external groups. This individual should have extensive experience in protein and protein conjugates testing and characterization. Experience with both large molecule and small molecule analytical development development is preferred.
This role requires close collaboration with leaders in both Development Sciences and Discovery/Research organizations across Abbvie including Quality, Regulatory Affairs, Research Chemistry, Antibody Engineering and DMPK.
- Mentorship and management of scientists within the Analytical/Formulation Development organization including resource balancing and driving of overall group strategy
- Coordination of analytical, formulation, and control system development for small molecules, biologics and ADCs
- Championing of key technical advances in analytical technologies/techniques for the characterization and structural elucidation of proteins, protein-conjugates and small molecules including chromatography, capillary electrophoresis, ELISA, bioassay and mass spectrometry.
- Oversight of the group's mass spectrometry core function, which supports some early research activities and supports all CMC development
- Oversight of method transfer activities into Quality Control
- Development of regulatory strategy surrounding analytical control systems and specifications in collaboration with Quality and Regulatory leaders
- Oversight of technical and strategic content of relevant CMC sections for INDs
- Oversight of formulation development activities including investigational product compatibility evaluations for GLP and clinical investigational products
- Oversight of technology and method transfer for later stage programs in collaboration with the rest of the Abbvie network.
- A PhD in Chemistry, Biochemistry, Chemical Engineering or related field with 10+ years of relevant industrial experience
- Demonstrated leadership of scientists, teams and projects
- Demonstrated success in analytical development and structural elucidation of therapeutic compounds
- Expertise in state of the art analytical techniques for large and small molecules
- Expert knowledge in CMC Quality and Regulatory requirements and expectations for large or small molecule compounds
- Exposure/ working knowledge of bioanalysis a plus
- Excellent oral and written communication skills
Equal Opportunity Employer Minorities/Women/Veterans/Disabled