QC Manager, Head of Immunology at US02 Lonza Biologics Inc.

Posted in Science 10 days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Hayward, California





Job Description:

 

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 manager is responsible for the safety and reliability of Lonza products and complies with quality and regulatory requirements.  The role works closely with other leads to plan, organize, and direct the routine activities of the Immunology Quality Control Laboratory.  The manager assists the Head of Quality Control in making critical decisions related to the method life cycle, release raw materials, in-process, and finished products testing. 

The Immunology Manager will be the subject matter expert on biological techniques and biochemical assays (ELISA, CE-SDS, icIEF, SDS, qPCR), validation, and technology transfer. 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

  • 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.

  • Identifies potential risks associated with laboratory operations and leads teams to resolve lab issues.

  • Interprets applicable quality and regulatory requirements (e.g. FDA, GLP, QSR, cGMP, USP and CFR rules and guidelines).

  • Performs other duties as assigned.

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.