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Manager Quality Control Microbiology

Company: Seattle Genetics, Inc.
Location: Bothell
Posted on: February 16, 2020

Job Description:

Summary: The Quality Control Group at Seattle Genetics is seeking an experienced and motivated professional to manage personnel located in Quality Control testing group. The successful candidate will be responsible for oversight of microbial testing and programs, oversee method transfer/qualification/validation testing execution, lead lab investigations and troubleshoot assays performed in QC to ensure the product quality of monoclonal antibodies and Antibody Drug Conjugates (ADCs).Principal Responsibilities:

  • Managing personnel in Quality Control laboratory by overseeing day-to-day tasks, goal setting, projects and continuous improvement initiatives
  • Responsible for training, mentoring and career development of laboratory analysts
  • Making decisions around complex issues associated with analytical procedures that may impact manufacturing operations, key programs and/or inter-department processes
  • Overseeing laboratory investigations, deviations, CAPAs and troubleshooting
  • Representing the QC department on integrated project teams, acting as a liaison with other functions within the company and presenting key information to senior management
  • Maintaining cGMP compliance within all areas of responsibility
  • Responsible for writing, review and/or approval of technical reports, SOPs and other documents to support development, manufacturing, quality operations and regulatory submissions
  • Representing QC for regulatory inspections and internal audits
  • Working with Development teams to oversee method optimization and execution of method transfer/co-qualification/validation protocolsRequired Qualifications:
    • BS in life sciences with 9+ years working experience in pharmaceutical or biotech field
    • 3+ years of people management experience coaching employees in day-to-day performance, goal setting and career development
    • 5+ years hands-on experience with Quality Control testing in a regulated environment (GMP, GLP, etc.)
    • Good communication skills to lead a team and influence other leaders within Quality Control
    • Possess strong data interpretation, method troubleshooting skills and sound scientific judgement
    • Strong time management skills with attention to detail and desire to achieve team and individual goals
    • Be comfortable working in a team environment and interacting with other team members within the group and various departments of the companyPreferred Qualifications:
      • BS in Microbiology with 12+ years working experience in pharmaceutical or biotech field
      • 5+ years of people management experience coaching employees in day-to-day performance, goal setting and career development
      • 5+ years hands-on experience with Quality Control Microbiology testing, such as environmental monitoring, bioburden and endotoxin, in a regulated environment (GMP, GLP, etc.)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 .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.#LI-DD1

Keywords: Seattle Genetics, Inc., Seattle , Manager Quality Control Microbiology, Executive , Bothell, Washington

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