What are the responsibilities and job description for the Viral Vector Manufacturing Supervisor position at Lonza Group?
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
Salary : $44,000 - $71,000