QC Manager, Head of Biochemistry

United States, Hayward (California)

Today, Lonza is a global leader in life sciences operating across three continents. 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.

QC Manager, Head of Biochemistry works closely with the Head of QC to lead, plan, organize, direct, and evaluate the routine activities of the Biochemistry Quality Control Laboratory. The manager 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 leads teams to resolve lab issues. Trains and develop quality control analysts.

The Biochemistry Manager will be the subject matter expert on biological techniques, biochemical assays (ELISA, CE-SDS, icIEF, SDS, qPCR), and validation strategies. The manager will identify and implement new technologies for rapid methods and provide guidance to improve testing efficiency, investigations, and assay life cycle management.

Key Responsibilities:

  • Leads and develops a team of quality control analysts and scientists
  • Releases in-process, stability, and finished product samples
  • Serves as QC representative for external and internal projects
  • Develops, validates, and transfers biochemical assays
  • 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)
  • Leads and supports the installation of new analytical instrumentation.

Key requirements:

  • Advanced years’ experience in the biopharmaceutical or pharmaceutical industry. 
  • Minimum five years’ experience of managerial experience 
  • Bachelor of Science in Biochemistry, Chemistry, Biological Sciences, or closely related field. 
  • Strong analytical and problem-solving skills. 
  • Strong leadership skills and demonstrated successes in managing a small to medium-sized team (5-12).
  • Method validation and transfer (biochemical and biological assays) 
  • Laboratory software (Empower, ChemStation, MODA)
  • 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 is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements 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: R42723