Senior Aseptic Manufacturing Leader

PCI Pharma Services; Bedford (NH); On-site; USD 110,000 - 150,000; Full time

Job summary

PCI Pharma Services seeks a Manufacturing Manager in New Hampshire to lead all manufacturing operations for the site and product types, including aseptic and lyophilization processes. You will manage staff, drive safety, ensure cGMP compliance, and coordinate with Quality, Validation, and Project Management to meet production schedules and budgets.

The role requires strong leadership, deep manufacturing expertise, and the ability to optimize processes in a highly regulated environment.

Qualifications

• BA science degree or equivalent.
• Minimum of 5 years of relevant pharmaceutical or medical device manufacturing experience.
• Proven aseptic process leadership experience.
• Must understand cGMP and WW regulatory requirements (e.g. EU) for parenterals; familiar with ISO 5/6 environments. Gowning experience necessary.

Responsibilities

• Directs manufacturing operations to meet schedules and quality standards.
• Leads safety initiatives and ensures compliance with PCI procedures.
• Oversees cleanroom operations in cGMP environments.
• Coordinates staffing, training, and equipment maintenance for production.
• Reviews batch records, SOPs, deviations, and change controls.
• Collaborates with Quality, Validation, Facilities and Project Management.
• Manages department budget and supports process improvements.

Skills

People leadership

Manufacturing operations

cGMP knowledge

Quality teamwork

Education

BA science degree

Tools

Cleanroom equipment

Job description

PCI Pharma Services seeks a Manufacturing Manager in New Hampshire to lead all manufacturing operations for the site and product types, including aseptic and lyophilization processes. You will manage staff, drive safety, ensure cGMP compliance, and coordinate with Quality, Validation, and Project Management to meet production schedules and budgets.

The role requires strong leadership, deep manufacturing expertise, and the ability to optimize processes in a highly regulated environment.