QC Manager, Method Verification/Validation

United States, Hayward (California)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The QC Manager, Method Verification/Validation is responsible for leading a team of QC scientists and analysts who are accountable for method transfers, validation/verification, cleanability, and customer driven projects/studies. The manager will also supervise, plan, organize, direct, and evaluate all test methods and analytical instrument management activities. 

The manager is the Subject Matter Expert (SME) on method validation, method transfer, regulatory guidelines (ICH, USP, JP, EP), representing the QC laboratory during customer and regulatory audits.

Key Accountabilities

  • Leads method transfers, method verifications, and method validations and ensures compliance with regulatory and Lonza requirements.
  • Attends project team meetings as the QC representative and works closely with the team to ensure on-time delivery
  • Maintains site test methods and critical reagents, including periodic review, trending, and extension.
  • Performs technical studies for key stakeholders such as manufacturing, MSAT, and external customers.
  • Performs qualification and validation of analytical equipment
  • Participates and supports regulatory audits and serves as Hayward’s analytical methods SME
  • Works closely with site and global analytical teams to ensure compliance with regulatory updates (i.e., compendial monitoring).
  • Creates, revises, and reviews quality GMP documents, i.e., local SOPs and assay worksheets
  • Ensures employees are adequately trained and makes appropriate staff recommendations.
  • Manages capital projects and operating budgets for the team
  • Transitions to a routine testing group when needed.
  • Performs other duties as assigned. 

Key Requirements

  • Advanced experience in analytical/QC testing in pharmaceutical or biopharmaceutical laboratories.
  • Strong analytical and problem-solving skills.
  • At least five years’ experience with method validation, method transfer, and method troubleshooting. Preferred experience in ELISA, qPCR, CESDS, HPLC, and icIEF.
  • Laboratory software (Empower, ChemStation, MODA, LIMS)
  • Prior experience in management (5+ years)
  • Strong leadership skills and demonstrated successes in managing a small team.
  • Comfortable and capable of growing into a controlled manufacturing environment
  • Excellent verbal and written communication skills
  • Success with working with multifunctional teams (global and local)

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement themselves.  At Lonza, we respect and protect our people and our environment.  Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R26615