Biopharma Manufacturing Leader

pciservices; Bedford (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

PCI is seeking a Manufacturing Manager to lead all aspects of manufacturing operations at our Bedford, NH site, supporting aseptic, non-aseptic, lyophilization, and drug/product manufacturing as assigned.

You will ensure cGMP compliance, manage budgets, coordinate with Validations, Quality, Facilities and Senior Management, mentor staff, and drive process improvements to achieve on-time production and high customer satisfaction.

Qualifications

• Proven experience leading manufacturing operations teams.
• Strong knowledge of cGMP and regulatory guidelines.
• Ability to manage budgets and drive cost efficiencies.
• Experience coordinating with Validation, Quality and Facilities teams.

Responsibilities

• Manage and direct staff to ensure continuous function of manufacturing operations and adherence to schedules.
• Lead safety initiatives for manufacturing and ensure department compliance with PCI safety procedures.
• Ensure cleanroom operations comply with cGMP and applicable SOPs.
• Support the production schedule for staffing, planning and equipment maintenance.
• Direct personnel to complete batch records and SOP documentation.
• Coordinate investigations, CAPAs, and change controls; support validation activities.
• Oversee training on product formulation, aseptic technique, contamination control and packaging.
• Collaborate with Validations, Facilities, Quality, Project Management and Senior Management.
• Other duties as assigned.

Skills

Staff management

Safety leadership

cGMP knowledge

Budget management

Cross-functional collaboration

Job description

PCI is seeking a Manufacturing Manager to lead all aspects of manufacturing operations at our Bedford, NH site, supporting aseptic, non-aseptic, lyophilization, and drug/product manufacturing as assigned.

You will ensure cGMP compliance, manage budgets, coordinate with Validations, Quality, Facilities and Senior Management, mentor staff, and drive process improvements to achieve on-time production and high customer satisfaction.