Sr. Manager/Associate Director, Quality Control
Seattle Genetics is seeking a highly motivated individual for a QC Sr. Manager/A.D./D., to lead a QC Laboratory at the Seattle Genetics manufacturing facility (North Creek) located in Bothell, WA. This position will be a member of the site’s Management Team and of the broader Seattle Genetics Quality Control organization. The QC leader is responsible for the microbiology, raw materials, in-process control, release testing and laboratory controls located within a biologics manufacturing facility using mammalian cell.
This position will work independently and collectively as part of an integrated team environment with extensive interactions with other Quality personnel, Validation, Compliance, Manufacturing, Supply Chain Logistics, and Process/Analytical development.
Managerial responsibilities include managing a group of scientists, SMEs, and analysts; representing QC within the manufacturing plant; working closely with QA and Manufacturing to ensure high quality, timely, scientifically rigorous and compliant data are provided; and contributing to the growth and build-out of the facility and the QC laboratories.
The person in this position will have demonstrated the ability of effectively leading Quality Control groups or functions within a matrixed organization.
- Manage the daily operations for a Quality Control laboratory supporting a biologics manufacturing facility – knowledge of environmental monitoring requirements for a biologics manufacturing plant (monitoring of utilities, plant, and people) and microbiology testing requirements for raw materials, in-process and release samples including bioburden and endotoxin testing and microbial identification. Oversee and monitor trending reports for microbiological programs and other QC relevant metrics, and manage all deviations
- Manage a group performing analytical testing of in-process and release samples including assay transfer from development and assay qualification. Assays include HPLC, UPLC, UV/Vis, Capillary Electrophoresis, and a number of compendial assays such as pH, FTIR, conductivity, osmolality, etc.
- Manage a group responsible for raw materials release, including sampling, specification development, critical reagent identification, compendia and non-compendia testing as needed
- Oversee the qualification, verification or validation of all QC assays performed at the facility
- Ensure cGMP compliance and data integrity
- Oversee OOS and OOT investigations and critical deviations
- Train and mentor laboratory personnel
- Participate in budget planning and resource allocation for the QC function at the manufacturing site
- Participate with the site Management Team to plan the site budget and activities that support Seattle Genetics manufacturing
- As a member of the QC Leadership Team, actively collaborate with other QC members to plan and execute the QC Department goals and strategy that supports the Seattle Genetics business
- Represent the site QC function during internal, external, and Health Authority audits and inspections
- BS/BA or MS/MA degree in the biological or chemical sciences with an emphasis on microbiology
- 15+ years of related laboratory experience in the operation of a testing laboratory in direct support of a cGMP biologics manufacturing facility
- 5+ years prior personnel management or supervisor experience
- Experience in routine environmental monitoring and data trending programs
- Ability to perform complex laboratory and troubleshooting procedures without technical supervision
- Demonstrated knowledge of, and ability to apply, cGMP regulations
- Prior interactions with domestic and international regulatory agencies
- Ability to effectively work in an interdisciplinary environment
- Proficiency in compendial raw materials testing and material specification system implementation desired
- LIMS experience desired
- Demonstrated proficiency in Excel/JMP or other statistical based software packages desirable
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.