QC Supervisor, Chemistry

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 Chemistry Supervisor works closely with the Head of QC to lead, plan, organize, direct, and evaluate the routine activities of the Chemistry Quality Control Laboratory.  The supervisor is responsible for the safety and reliability of Lonza products and complies with quality and regulatory requirements. Assist the Head of Quality Control in making critical decisions related to the method life cycle, release raw materials, in-process, and finished products testing. Identifies potential risks associated with laboratory operations and lead teams to resolve lab issues. Trains and develop quality control analysts.

The Chemistry Supervisor will be the subject matter expert on raw material testing (USP, JP, EP), analytical testing including but not limited to U/HPLC, GC, FTIR, and wet chemistry techniques.  The supervisor will also be responsible leading and participating in method transfers, evaluations and qualifications.

Key responsibilities:

  • Leads and develops a team of quality control analysts
  • Releases in-process, raw materials, stability and finished product samples
  • Validates and transfers analytical test methods
  • Leads and performs laboratory investigations and deviations. Opens and completes CAPAs on time.
  • Develops training modules and on the job training (OJT) SOPs.
  • Ensures compliance with testing SOPs and specifications
  • Monitors the testing techniques, accuracy of records and documentation
  • Interprets applicable quality and regulatory requirements (e.g. FDA, GLP, QSR, cGMP, USP and CFR rules and guidelines.
  • Participates in audits (regulatory, internal and customer) as raw material SME.
  • Leads and supports the installation of new analytical instrumentation.
  • Perform other duties as assigned.

Key Requirements:

  • Advanced experience in analytical/QC testing in pharmaceutical/biopharmaceutical laboratories.
  • Prior experience in management preferred
  • Strong analytical and problem solving skills.
  • Strong leadership skills and demonstrated successes in managing a small team.
  • Method validation and transfer (biochemical, and biological assays) experience preferred
  • Laboratory software (Empower, ChemStation, MODA, LIMS)
  • Comfortable and capable of growing into 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: R25686