Manager, Quality Control

Quality Seattle, Washington


Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics.  Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

 Zymeworks is seeking a Manager, Quality Control to provide management and support of analytical testing and stability studies in support of Zymeworks’ programs. This position will be based in Seattle and will report to the Director, Quality Control.

Key Responsibilities

  • Ensure Quality Control systems and procedures meet current GMP and regulatory inspection expectations.
  • Participate collaboratively with Quality Control members and other cross-functional teams to meet company strategic plans and objectives.
  • Provide direction and support for quality control for operational objectives and work plans.
  • Drive implementation and improvement of Quality Control systems and procedures.
  • Provide subject matter expertise to analyze data and troubleshoot QC testing issues.
  • Provide oversight and coordination of QC activities performed by external vendors and CMOs.
  • Ensure quality and on-time delivery of drug substance and drug product testing for release and stability testing.
  • Provide support and management of analytical technology transfer.
  • Ensure method validation and qualifications meet process and regulatory requirements.
  • Provides input and ensures the quality and completeness of investigations and changes is appropriate.
  • Proactively identify chemistry, manufacturing and controls (CMC) gaps and risks, and support development of mitigation plans.
  • Collaborate closely with CMC team members, to achieve key milestones and regulatory filing timelines and annual product updates.

Qualifications and Experience

  • Bachelor’s degree in a chemical or biological science discipline or equivalent (Master’s degree preferred) and a minimum of 8years’ GMP experience in the pharmaceutical/biotech industry with demonstrated increasing responsibility. An equivalent combination of education and experience may be considered.
  • Direct experience working in a biopharmaceutical quality control with a working knowledge of biologics development for drug substance and drug products.
  • Must have an understanding of QC stability programs for both drug substance and drug product.
  • Understanding of quality control scientific/technical concepts and test methods.
  • Must have expertise in one or more of the following areas: Chromatography, Immunoassays, Cell-based assays, Electrophoresis, Molecular Biology, Microbiology, Chemistry.
  • Regulatory inspection and product launch experience preferred.
  • Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
  • Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
  • Excellent technical writing and verbal communication skills.
  • Domestic and international travel (~10-20%) as needed.

Why Work for Us?

Zymeworks’ employees are passionate, engaged and extremely motivated to succeed.  We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big.  To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.