Manager, Manufacturing

PCI Pharma Services seeks a Manufacturing Manager to oversee all manufacturing operations at a Bedford, NH facility, directing staff and ensuring compliance with cGMP standards across aseptic, non-aseptic, and lyophilization activities. The role includes batch documentation oversight, process validation support, and cross-functional collaboration with quality and facilities teams.

Responsibilities

• Direct manufacturing staff and oversee continuous operation of drug product and device manufacturing lines
• Ensure compliance with cGMP, regulatory guidelines, and all applicable SOPs in cleanroom and production areas
• Lead safety initiatives and oversee batch record documentation, deviation reports, investigations, and CAPA activities
• Support production scheduling, staffing coordination, equipment maintenance, and process validation activities
• Manage training of operators in aseptic techniques, contamination control, formulation, and packaging procedures

Requirements

• Proficiency in pharmaceutical process development for aseptically produced products or medical device manufacturing
• Working knowledge of pharmaceutical facilities, lyophilization technology, and cleanroom manufacturing equipment
• Strong troubleshooting and root cause analysis skills with structured problem-solving methodology
• Demonstrated leadership experience managing operations staff and coordinating complex projects
• Excellent written and oral communication skills, particularly for technical reporting and client interaction
• Knowledge of cGMP regulations, SOPs, batch record documentation, and pharmaceutical quality systems