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Manufacturing Associate IV at US02 Lonza Biologics Inc. in Hayward, California

Posted in Manufacturing 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:

 

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 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:


  • Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate.

  • Demonstrate mastery and strong understanding of suite specific production activities and laboratory tasks such as bioreactor inoculation, chromatography column operation, product sampling, etc. and the scientific theory behind the operations and microbial controls.

  • Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects, demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).

  • Train other personnel on equipment operation, cGMPs, documentation, technical theory, microbial controls or other tasks. Maintain individual training plan.

  • Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.

  • Perform other duties as assigned. 

Key requirements:


  • High School Diploma or Equivalent minimum; AS/BS preferred

  • Preferred area of study:  Science related discipline

  • Advanced experience in manufacturing; GMP setting preferred, and/or 24 months experience as an Associate Level III in bio-pharm industry.

  • Proven logic and decision making abilities, critical thinking skills.

  • 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.

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.