Manufacturing Manager, Aseptic & cGMP Ops

PCI Pharma Services; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

PCI Pharma Services is seeking a Manufacturing Manager to lead all aspects of manufacturing operations at our location, overseeing aseptic and non-aseptic processes, lyophilization, and related activities. You will manage staff, schedules, budgets, and cross-functional collaboration with Quality, Validation, Facilities, and Project Management to deliver compliant, efficient production.

The role requires a BA in science and at least 5 years of pharma or medical device manufacturing leadership,

Qualifications

• Aseptic process leadership and strong understanding of cGMP in pharmaceutical/medical device environments.
• Experience coordinating cross-functional teams to drive compliant manufacturing.
• Ability to manage schedules, budgets and staff across complex operations.

Responsibilities

• Managing and directing staff to ensure proper and continuous function of all manufacturing operations and adherence to the established schedules
• Leads the safety initiatives for manufacturing and ensure department compliance with all PCI safety procedures, processes.
• Ensures that all operations of the drug/product cleanroom areas are being performed in accordance with cGMP and current regulatory guidelines as well as all applicable SOPs
• Supports the production schedule to meet requirements for staffing, work schedules, planning activities, and equipment maintenance
• Directs personnel to complete and review all associated batch record and SOP documentation
• Writes, reviews/approves investigation, OOT/OOS, EEIs and completion of deviation reports
• Writes, reviews/approves change control orders and CAPAs
• Coordinates assistance for Validation protocols, and other process studies. Coordinates activities for process enhancement projects and supports new product development projects
• Ensures training of operators to learn techniques for product formulation, preparation of materials/products, aseptic technique, contamination control, gowning, , labeling and packaging
• Oversees control of product manufacturing operation areas including cleanrooms, component prep and sanitization, filling, and packaging activities
• Works closely with Validations, Facilities, Quality, Project Management and Senior Management to ensure the needs of all functions are met
• Other duties as assigned, or as business needs require
• TRAVEL - <10%

Skills

Aseptic process leadership

cGMP knowledge

Project management

Staff leadership

Education

BA science degree, or equivalent

Job description

PCI Pharma Services is seeking a Manufacturing Manager to lead all aspects of manufacturing operations at our location, overseeing aseptic and non-aseptic processes, lyophilization, and related activities. You will manage staff, schedules, budgets, and cross-functional collaboration with Quality, Validation, Facilities, and Project Management to deliver compliant, efficient production.

The role requires a BA in science and at least 5 years of pharma or medical device manufacturing leadership,