Senior Manufacturing Associate

United States, Hayward (California)

Today, Lonza is a global leader in life sciences operating across three continents. 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 Senior Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Senior Associates are expected to demonstrate expertise and breadth of knowledge in executing process recipes across a variety of production activities, following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product sampling, and conducting routine sanitization tasks to maintain facility and equipment and train other operators on these tasks. They are expected to demonstrate expertise and technical leadership in cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. Senior Manufacturing Associates are able to troubleshoot complex and non-routine equipment events, initiate and assess deviations, review batch records and logbooks. May be asked to assume responsibilities for covering shift supervisor absences/vacations.

Key responsibilities:

  • Lead and direct the safety, quality, and daily production operations for suite.
  • Oversee all tasks on the floor as they are carried out and provide assistance and troubleshooting where required.
  • Coordinate with other departments to ensure on time delivery of the production schedule.
  • Demonstrate expertise and breadth of knowledge on process flow and in executing process recipes across a variety of production activities based on education, training and hands-on production experience.
  • Administrative tasks – leading shift exchange, assigning duties, attending meetings, sending/receiving emails, participating in continuous improvement projects.
  • Demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).Completes batch records and logbooks contemporaneously
  • Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.Complete daily inventory and labor transactions.
  • Adherence to cGMPs, written procedures (SOPs), housekeeping, 6S, use of electronic document and inventory systems (DMS/SAP), monitoring equipment and processes, product sampling, and equipment sanitization tasks.
  • Escalates process challenges and proposes solutions Compliance

Key requirements:

  • High School Diploma or Equivalent minimum;  AS/BS preferred Science related discipline
  • 5 - 7+ years’ experience in manufacturing of biotechnology products; (7 to 10+ Years’ experience without AS/BS); GMP setting preferred Strong written and verbal communication skills are required.
  • Downstream - Unicorn, Akta Ready/XL chromatography, column operations, ultrafiltration, buffer preparation experience preferred
  • Upstream - Deltav, Single Use Bioreactor operations, High capacity filtration (3M depth filter and Millipod) Vi-cell, Hi-res Cedex cell counter, cell culture operations experience, buffer and media preparation experience preferred
  • Strong written and verbal communication skills are required.
  • The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities.  Is open to and actively seeks out feedback on their performance and translates that feedback into action.

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 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: R38158