Scientist II, Quality Control
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.
As part of a talented, dynamic and fast-paced team, the successful applicant will support various aspects of QC testing for antibody drug conjugates. This opportunity will involve HPLC, CE-SDS, iCIEF, KF and other analytical methods for in process testing, lot release, and stability testing. Assistance with validation of new methods in a cGMP environment will also be required. This position requires excellent laboratory skills and great attention to detail at the bench and with documentation. There is an opportunity to grow and own projects or processes in areas of analytical method improvements, procedure writing, method validations, etc. Key Responsibilities Include:
- Perform testing of in process samples, lot release and stability samples in support of cGMP activities
- Review data generated by other analysts for correctness and compliance with cGMP standards
- Support QC team with validations of new methods; update documents and procedures
- Write, review and revise QC standard operating procedures and analytical test methods
- Assist with troubleshooting of analytical instruments
- Support investigations such as OOT and OOS
- May supervise junior level scientist
- Share responsibilities with the team to support sample and equipment management, and assist in maintaining the QC lab and its systems in a cGMP compliant state.
- Be able to communicate effectively verbally and in writing.
- Ability to work independently with little or no direct supervision.
- Be able to establish and maintain work schedule goals.
- Ability to multi-task, effectively manage timelines, great attention to detail and team-oriented personality are a must.
- BS or MS degree in a scientific discipline.
- 5+ years working in a regulated (GMP) laboratory environment preferably with QC experience
- Demonstrated expertise in analytical techniques such as HPLC, iCIEF, KF, CE-SDS, etc.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled