MSAT SME PPQ

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 Subject Matter Expert PPQ will be responsible for the day-to-day  activities to support  process performance qualification  batches reporting directly to the MSAT Manager, Process Validation & Commercialization and supporting all Hayward process commercialization stages.

Key responsibilities:

  • Provides senior technical leadership and guidance to both internal (eg. commercial development, proposals support teams) and external customers’ requirements in defining technical scope, planning, scheduling and overseeing the MSAT project support both pre and post validation activities according to business plans and site/customer requirements relating to new Biologics License Applications and on-going commercial manufacturing operations.
  • Support the execution of the activities within the Hayward manufacturing facility if required as well as written protocols for studies required and reports to support the customer commercial programs.
  • Manage timelines of activities with Line manager to ensure delivery on time.  
  • Provides broad technical knowledge/expertise to  support the safety, compliance and Quality Systems activities required during GMP operations to ensure site KPI’s  are met and continually monitored
  • Uses external global network as site MSAT technical lead in participating in the global technical operations to develop the scope for process validation execution (Process Performance Qualification) procedures in line with industry and regulatory expectations.

Key requirements:

  • Bachelors/Masters – Relevant field of study (PHD preferred)
  • Advanced Experience - MSAT, manufacturing validation, research and development
  • Ability to analyze data sets and determine requirements of a process for supporting commercial projects and critical process parameters
  • Experience and have the Ability to perform pFMEA and determine additional studies.
  • Effective communication and experience in customer facing environment.

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: R29008