QA Raw Materials Project Manager

United States, Portsmouth (New Hampshire)

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 QA Project Manager Raw Materials is assigned as the primary liaison to Technology Transfer Teams. The QA Project Manager Raw Materials will be a technical and quality resource for the Project teams to include: Project Management, Quality Control Technical Services and Materials Science and Technology associates. QA Project Manager Raw Materials will participate in internal and joint quality meetings regarding materials tech transfer that include Lonza Customer representatives and other Lonza site personnel. The QA Project Manager Raw Materials will use their regulatory and technical knowledge to assist the technology transfer teams in trouble shooting issues for raw materials.

Key responsibilities:

  • Participate in Technology Transfer Teams to support the onboarding of Raw Materials. Including but not limited to, assisting in the development of appropriate testing matrixes and selection of materials for given processes, Providing knowledge to process team, review and approval of vendor documentation.
  • Support the Deviation, and Change Control through assessment and participation in team events
  • Review of Technical Reports regarding raw materials to include: Testing Matrixes, Leachable Extractable reports, Risk analysis, BSE/TSE Statements
  • Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert for any customer related raw material discussions.
  • Train coworkers in Technology Transfer activities
  • Perform other duties as assigned.

Key requirements:

  • High school or equivalent required. Bachelor’s degree with field of study in Chemistry, Biochemistry, Engineering preferred.
  • Substantial experience in a GMP environment, biotech, pharmaceutical, chemical industry desired.
  • Significant experience within a quality assurance function.
  • Knowledge of Biotechnology Manufacturing processes and procedures.
  • Working knowledge of the applicability of ICH Quality Modules (ICH Q7) United States Pharmacopeia, European Pharmacopoeia, Japanese Pharmacopoeia.
  • Full understanding of Material Attribute requirements such as (not all inclusive): BSE/TSE, Allergens, Leachable Extractables, Proper Storage conditions, Physical attributes of a material and impact on process.
  • Ability to balance and prioritize tasks
  • Willingness to ask questions and/or to seek input from more experienced peers and management
  • Ability to maintain and build internal and external relationships, works effectively individually and with teams
  • Questioning attitude and critical thinking required to make quality related decisions
  • Displays a clear willingness to listen to others
  • Demonstrates quality decision making
  • Solid written and verbal communication, good attention to detail and self-motivation

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 it is 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: R26182