Description Summary: The Quality Control Group at Seagen is seeking an experienced professional with broad experience in analytical and quality aspects of biopharmaceuticals to help manage method transfer, method qualification and/or validation, and clinical projects supporting CMC activities. This position is responsible for working with internal development groups, internal testing colleagues, and CMOs or CROs, overseeing the quality of monoclonal antibodies and Antibody Drug Conjugates (ADCs). Responsibilities: The ideal candidate will be responsible for representing Quality Control on CMC clinical development teams at Seattle Genetics and working with contract facilities to support drug development from early phase candidates to late phase products. This position will require experience in several quality areas such as analytical testing and review, method transfer, qualification and validation, developing specifications, authoring stability documents, and interpreting regulations and guidance documents. 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 and established understanding of monoclonal antibody and ADC product quality, experience managing Quality investigations and troubleshooting, assay study design and technical report writing. This position will manage several projects which require excellent time management and frequent cross-departmental communication/collaboration. Required Qualifications:
Working experience in pharmaceutical or biotech field
Scientist: BS with 10+ years, or MS with 8+ years
Sr. Scientist: BS with 12+ years, or MS with 10+ years
Excellent analytical mindset and skills including hands on experience with analytical methods such as UPLC, SE-HPLC, RP-HPLC, CE-SDS, and USP compendial testing, etc.
Strong method troubleshooting skills and scientific understanding of protein chemistry
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 not required but 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)
As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visitwww.seagen.com. Seagen 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.