12-Hour Aseptic GMP Manufacturing Supervisor

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services seeks a Supervisor, Manufacturing to lead a 12-hour aseptic production shift in Bedford, NH. This role oversees equipment prep, formulation, filtration, aseptic/non-aseptic filling in an isolator, and lyophilization to execute the production plan across shifts while ensuring safety and quality.

You will coach and develop staff, implement training, monitor KPIs, and work with Planning and cross-functional teams to optimize processes and address deviations in a strong cGMP

Qualifications

• Minimum High School Diploma.
• 5-7 years of experience in a GMP environment.
• 3-5 years of experience leading direct reports or teams.
• Experience with GMPs, FDA and other regulated agency environments is required.
• Ability to make real time decisions on safety, process, scheduling and personnel-related issues.
• Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs.
• Proven leadership, persuasiveness, initiative, and problem solving skills.

Responsibilities

• Lead a 12-hour production shift for aseptic manufacturing.
• Ensure safety of manufacturing area and work practices.
• Coach, motivate, and retain high-performing teams.
• Coordinate and supervise Manufacturing personnel in cGMP operations.
• Train employees to ensure FDA and regulatory requirements are met.
• Plan and execute manufacturing instructions for equipment prep, compounding, filtration, formulation and fill activities.
• Partner with Planning to ensure scheduling adherence and capacity.
• Collaborate with enabling groups to optimize processes.
• Recruit and supervise staff and manage resources.
• Identify risks and escalate issues to management.
• Establish KPIs and report metrics.
• Collaborate with Training to design and execute training plans.
• Ensure investigations and CAPAs are completed timely and perform Real time batch review.

Skills

Team leadership

GMP experience

Regulatory knowledge

Priority management

Problem solving

Safety decisions

Education

High School Diploma

Job description

PCI Pharma Services seeks a Supervisor, Manufacturing to lead a 12-hour aseptic production shift in Bedford, NH. This role oversees equipment prep, formulation, filtration, aseptic/non-aseptic filling in an isolator, and lyophilization to execute the production plan across shifts while ensuring safety and quality.

You will coach and develop staff, implement training, monitor KPIs, and work with Planning and cross-functional teams to optimize processes and address deviations in a strong cGMP