Microbiology/Stability Supervisor

United States, Rochester (New York)

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.

Plan, direct, and coordinate the receipt, sampling, storage, transfer and distribution operations Supervise and coordinate microbiology analysts performing routine and non-routine analyses of products and raw materials in a GMP laboratory setting. Review, approve and interpret test data to support release of in-process materials, finished products, raw materials and stability samples. Review, develop and validate methods and procedures to meet regulatory standards and increase effectiveness for the microbiological laboratory. Oversee Stability Program for GMP products.

Key responsibilities:

  • Responsible for supporting the Lonza philosophy, “The Goal is Zero” in his/her job routine.  Works to attain the purpose, “Zero injuries, Zero process incidents, Zero distribution incidents, and Zero environmental incidents”.
  • Supervise microbiology technicians supporting routine testing and project work.
  • Coordinate work schedules and assignments of laboratory technicians to assist in meeting production goals.
  • Create protocols for specialized testing, method validations and equipment validations.
  • Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
  • Produce reports regarding non-conformance of products or processes, daily production quality, root cause analyses, or quality trends.
  • Assist microbiology laboratory technicians in conducting routine and non-routine microbiological analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
  • Recommend or execute personnel actions, such as hiring, evaluations, or promotions.

Key requirements:

  • Bachelor Degree in Biology or related science
  • Advanced years of experience in a similar role
  • GMP/Regulatory Knowledge
  • Procedure/Protocol/Report Writing
  • Quality Control Analyses
  • Critical Thinking/Problem Solving
  • Personnel Management

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.

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.

Reference: R20402