MSAT Manager Process Validation and Commercialization

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 MSAT Manager, Process Validation & Commercialization has responsibility for day-to-day line management of MSAT technical Subject Matter Experts (SME’s) and senior level scientists supporting all Hayward process commercialization stages.

Key responsibilities:

  • Provides technical governance on all aspects of planning, execution and support of Biologics License Applications (BLA’s) from development into GMP manufacturing operations on site and via the global MSAT network.
  • Responsibility for completion of all process validation activities including all ongoing post validation (commercial production) stages of work.
  • To technically influence change and support, the business processes through cross-functional interaction with both internal proposals and commercial development teams and external customers through the project life cycles.
  • As required resolving complex technical problems and making informative decisions working with customers in a collaborative and influential way.
  • Represent the Hayward MSAT function via the global technical operations network, ensuring knowledge sharing and constant compliance to global procedures at all times.

Key Requirements:

  • A minimum Masters/Bachelors in biological sciences/Biochemical engineering or equivalent field
  • Advanced years’ experience in laboratory or manufacturing scale operations in biopharmaceutical development technology transfer of manufacturing environments
  • Previous team line management and or project management experience essential
  • Knowledge in mammalian cell Upstream and Downstream process validation essential and aware of current regulatory and industry standards and GMP guidance
  • Demonstrated people management skills and leadership essential with credibility to influence business and customer outcomes
  • Excellent attention to detail, with ability to prioritize and be flexible in managing change, anticipating and resolving complex technical and business problems with ability to positively impact customer relationships and external technical network

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: R25227