Quality Control Senior Analyst/Scientist

Global Quality Bothell, Washington


Description

Summary: 

This position is responsible for leading the Raw Material risk assessment process and ensuring compliance of the Raw Material testing paradigm in accordance with standard operating procedures (SOPs) and all applicable pharmaceutical regulations and guidelines. Additional responsibilities include leading the Analytical Method Transfers for support of in-process testing.

Principal Responsibilities:

  • Conducts raw material risk assessments in support of site manufacturing of mAb and ADC conjugation
  • Assesses raw material specifications with compendia and supplier guidance to determine raw material release testing requirements
  • Develops, generates and implements raw material and manufacturing aid specifications for materials used in clinical and commercial manufacturing settings
  • Develops, implements and maintains the raw material qualification program
  • Manages outsourced testing of contract testing laboratories
  • Authors and revises methods and SOPs
  • Oversee the qualification/verification and/or transfer of analytical methods to support in-process and raw material release testing
  • Collaborate with Manufacturing, Materials Management and Quality Assurance groups to ensure proper use and testing of materials
  • Serve as raw material subject matter expert for New Product Technical Transfers
  • Conducts laboratory investigations, as needed
  • Act as the subject matter expert during internal/external compliance audits and to support vendor qualifications
  • Provides support during internal and external Regulatory Inspections
  • Performs routine maintenance of laboratory equipment
  • Provide trouble-shooting expertise of analytical instrumentation
  • Trains others in basic through complex laboratory techniques
  • Maintains close communication and interaction with QC management and staff to ensure on-time testing of samples
  • Fully complies with company health and safety procedures
  • Weekend, on call, and shift work may be required

Required Qualifications:

  • 10+ years relevant experience in the biotech or pharmaceutical industry
  • Extensive knowledge of multi-compendial testing requirements (USP, EP, JP)
  • Extensive knowledge of regulatory requirements and guidelines as they relate to pharmaceutical manufacturing (ICH, CFR, FDA)
  • Knowledge of biological and/or chemical handling
  • Basic understanding of biologics manufacturing processes
  • Excellent communication and collaboration skills
  • BS/BA degree in the biological or chemical sciences

Preferred Qualifications:

  • 3+ years of cGMP related raw material experience in the biopharmaceutical industry
  • 3+ years of analytical testing experience preferred (General Wet Chemistry Techniques, Titrations, HPLC, UV-Vis)

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.

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