Today, Lonza is a global leader in life sciences operating across five 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.
Job Description:
Supervises production processes and manufacturing personnel. Leads the transition of new processes from PD to manufacturing. Reviews and approves Batch Records, Change Controls, Deviations, SAP and other manufacturing documentation required for cGMP production operations. Provides training to manufacturing technicians and ensures compliance of team on training. Coordinates the production schedule and maintains raw material inventory to support operations. May also perform such cGMP manufacturing tasks as operation of large scale cell culture bioreactors, large scale chromatography and aseptic filling. Responsible for overall cGMP compliance of the department and may represent manufacturing on project teams or during external audits.
Key Responsibilities:
Responsible of the adherence to safety and cGMP regulations of the team.
Execution of USP/DSP activities in the clean room.
Planning of daily activities in the clean room and provide first line of problem solving in case of any event.
Provides technical expertise and instruction to the Core level technicians.
Coaching, mentoring and performance review of the team.
Escalation to management and interaction with other stakeholders in case of any event (Deviation Investigation Team, QA, MSAT, FE, etc.)
Contributor or leader on MFG and OE projects to optimize and streamline processes.
Completes and reviews batch records and production documents.
Reviews and approves Batch Records, Change Controls, Deviations and other documentation required for production operations.
Writes and revises SOPs as required
SME during audits for all activities performed in the applicable area.
Performs other duties as assigned.
Key Qualifications:
- High school Diploma is required
- Learns from experience, errors and setbacks
- Helps others learn from experience to develop themselves
- Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
- Embraces new initiatives and drives successful implementation in his/her area
- Adapts thinking and behavior to support change
- Takes personal responsibility for promoting change in his/her area
- Understands how to effectively engage others in the change processes
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.