AbbVie Senior Manager, Quality Control Validation in South San Francisco, California

Senior Manager, Quality Control Validation

USA, California, South San Francisco

Quality Assurance

Requisition #1804849

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.

Description

As part of a talented and multi-disciplinary team advancing an exciting novel approach to drug development, the successful candidate will lead method validation and transfer activities associated with QC testing of the Company’s GMP products.

The successful candidate will be responsible for providing strategic leadership and technical expertise overseeing in-house validation and method transfer activities as the company progresses through clinical trials. This is a hands-on role that requires close collaboration with Quality Control, Analytical Development, Research, Manufacturing, Quality Assurance and Regulatory groups.

Primary Duties and Responsibilities:

  • Coordinate/collaborate with the Analytical Development and Research Bioassay teams to define methods required for the control system for release and stability testing of monoclonal antibody intermediates, antibody-drug conjugate drug substances and drug products

  • Coordinate/collaborate on method optimization and transfer from the Analytical Development and Research Bioassay Teams to Quality Control

  • Oversee determination of appropriate system suitability criteria based on data trending

  • Establish appropriate timelines for QC validation activities

  • Establish validation strategies that are phase appropriate and drive validation strategy and execution to meet required timeline

  • Prepare and provide technical review of relevant documentation including test methods, transfer documentation, validation protocols, reports and raw data

  • Approve final test methods after validation in alignment with control strategy as well as after any revisions

  • Serve as a technical advisor to the critical reagent control and monitoring program

  • Collaborate on the development of specifications for intermediates, drug substances, drug products and reference standards

  • Assist in the preparation of CMC regulatory submissions

  • Implement new technology and instrumentation into QC lab to maintain state-of-the-art control systems

  • Provide technical expertise necessary for troubleshooting instrumentation, investigating unexpected results/deviations, optimizing QC methods and developing appropriate CAPAs

Required Skills and Specifications:

  • In-depth knowledge of analytical methods used for monoclonal antibodies and antibody-drug conjugates (Bioassay experience a plus)

  • Experience with optimizing assays for a QC environment, including defining appropriate system suitability

  • Demonstrated track record of leadership in method validation activities, including development of supporting documentation and managing timelines

  • Experience managing method transfers

  • Experience with LIMs systems and electronic document management and quality management systems a plus

  • In-depth experience with regulatory/pharmacopeia requirements for biologic product testing and validation

  • In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements

  • Excellent interpersonal skills, organizational skills and communication skills including the proven ability to manage direct reports and influence collaborators in other departments

  • Excellent verbal and written communication skills

  • Ability to operate in a fast-paced, multi-disciplinary industrial environment

Educational Qualifications:

  • A minimum BS, but preferably an MS or Ph.D in Biological Sciences, Biochemistry or Chemistry

Experience:

  • Minimum of 8+ years of experience in the biotechnology or pharma industry with experience in biologics

Equal Opportunity Employer Minorities/Women/Veterans/Disabled