Senior Manufacturing Associate at Lonza Biologics, Inc.
Posted in Science 30+ days ago.
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Location: Portsmouth, New Hampshire
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description SummaryThe 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 Accountabilities and Duties:
- 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 documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate.
- Attain qualification for all assigned tasks and maintain individual training plan.
- Demonstrate proficiency at laboratory tasks, such as monitoring pH, conductivity, product sampling etc. May train other associates on these tasks.
- Perform material movements, transfer materials and chemicals in, out, and across the production areas.
- Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
- Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects.
- Perform other duties as assigned.
Minimum Required Qualifications/Skills:
- Preferred area of study: Science related discipline
- Level of Experience: Intermediate in manufacturing; GMP setting preferred, and/or 24 months experience as an Associate Level II 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.
Lonza. The place to Go, Stay and Grow.