Quality Control Analyst III/Senior

Global Quality Bothell, Washington


Description

Summary:

The Quality Control ASAT Group at Seagen is seeking an experienced professional with experience in analytical and quality aspects of biopharmaceutical testing. This position will be a supportive role to assist in managing plate-based method transfers, qualifications and/or validations, and will support critical reagent inventory maintenance activities for clinical and commercial projects. This position will also be expected to collaborate with internal development groups, internal testing colleagues, and CMOs or CROs to facilitate or lead the implementation of plate-based methods. The candidate will be expected to review data/assays, serve as a source of potency and impurity expertise, and actively support global critical reagent inventory management.

 

Responsibilities:

  • Assist the potency method transfer coordinators to manage the successful transfer of plate-based methods into QC to enable GMP testing
  • Represent QC to external development collaborators.
  • May represent QC on external manufacturing teams as SME (experience-dependent)
  • Review assays and perform extensive data verification to support plate-based method transfers & validations across multiple programs
  • Support or lead method performance troubleshooting, data mining, and in-depth data analysis
  • Support general critical reagent inventory management (physical counting, organizing, draft & upload certificates, manage history files, etc.)
  • Perform critical reagent qualification experiments
  • Facilitate material transfers and/or critical reagent shipments to external partners
  • Work extensively within Quality systems such as EDMS, change control, CAPA
  • This position will be partially lab-based which will require an on-site presence (estimated 50-75% on-site)

 Qualifications:

  • Excellent analytical mindset and skills including hands on experience with plate-based methods such as ELISA, PCR, Impurities, Bioassays, Effector-function, and cell-based assays.
  • Recent, hands-on experience with plate-based methods (i.e. binding, impurity, cell-based, etc.), experience in
  • Experience performing or leading method transfers to QC as well as planning and/or participating in method validations
  • Strong method troubleshooting skills (including in-depth data mining & analysis) and scientific understanding of potency methods for biomolecules
  • Experience leading Quality investigations
  • Familiarity or experience with plate-based method supporting operations are also preferred (i.e. critical reagent qualification, inventory management, etc.)
  • 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 project and company goals
  • Excellent verbal and written communication skills (SOPs, test methods, professional reports, emails)
  • Ample development and growth opportunities are available if consistent performance is demonstrated and deliverables are met over time
  • The position will require outstanding collaboration skills and technical expertise to manage method-related issues both internally and with contract facilities

 Education:

  • BS or MS in life science field and relevant lab experience in the pharmaceutical or biotech field
  • Analyst III: (BS) 5+ years or (MS) 4+ years
  • Analyst: (BS) 8+ years or (MS) 6+ years

  
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 visit 
www.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.  


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