QC Scientist/Senior Scientist
The Quality Control ASAT at Seattle Genetics is seeking an experienced professional with broad knowledge and experience in analytical and quality aspects of biologics to support CMC analytical activities for clinical and commercial programs. This position is responsible for collaborating with internal stakeholders and global partners, leading method validation/qualification and method transfer in global testing sites, ensuring phase-appropriate analytical methods and testing strategies are established for product release and stability testing, supporting regulatory submissions, and overseeing the product quality of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
The ideal candidate will be responsible for representing Quality Control on cross-functional project teams at Seattle Genetics and working with different functions to support biologics manufacturing and testing from early phase development to commercialization. This position will require experience in several quality areas such as analytical testing and critical review, method validation and transfer, method lifecycle management, developing specifications, evaluating product stability, and interpreting regulatory guidelines. The position will require outstanding collaboration skills in order to work through projects and issues internally and with contract facilities. The candidate must have a strong understanding of the product quality of mAbs and ADCs; experience in designing method validation and method transfer plan and ensuring execution to meet accelerated timelines, managing analytical investigation and assay troubleshooting, and authoring comprehensive technical reports. This position will manage several projects which require excellent time management and frequent cross- departmental communication/collaboration.
- BS or MS in life science field with 8+ years (MS) or 10+ years (BS) working experience in pharmaceutical or biotech field
- Excellent analytical mindset and skills including hands on experience with analytical methods such as RP-UPLC, SEC, HIC, CE-SDS, icIEF, Peptide mapping, and USP compendial testing, etc.
- Strong method troubleshooting skills and scientific understanding of protein chemistry
- Extensive experience in working with CMOs/CROs, managing method validation and method transfer among different testing labs, and supporting testing lab selection
- Familiarity with the investigation of deviations/OOS, and change management
- Familiarity with regulatory filings such as IND, IMPD, and BLA
- Familiarity with regulatory guidance documents (ICH, USP, CFR, general guidance)
- Prior working experience in a regulated environment (GMP, GLP, etc.) is preferred
- Excellent time management skills with attention to details and desire to achieve team and individual goals
- Be comfortable working in a team-driven environment, frequently engaging with inter-department and intra-department project teams in support of program and company goals
- Excellent verbal and written communication skills (SOPs, professional reports, emails)
- Some domestic and international travel is expected
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.