Director, Aseptic Manufacturing & Site Operations

PCI Services; Tennessee; On-site; USD 150,000 - 190,000; Full time

Job summary

PCI Pharma Services seeks a Director of Manufacturing for its Bedford site to lead aseptic and non-aseptic production in line with strict quality, regulatory, and safety standards.

You will support managers and staff, drive continuous improvement, and partner with the Senior Director of Operations to plan across multiple buildings within Bedford. Strong leadership and regulatory knowledge are essential.

Qualifications

• 10+ years direct management experience with increasing responsibility.
• 10+ years in cGMP pharma or medical device manufacturing; aseptic fill/finish preferred.
• Prior CDMO experience strongly preferred.
• Lyophilized products experience preferred.
• Knowledge of FDA, ICH, and EU pharmaceutical regulations.
• BS in a STEM field required.
• Excellent written and verbal communication skills.
• Ability to lead other leaders in a fast-paced environment.
• Ability to work with minimal supervision and drive solutions.
• Travel <10%.

Responsibilities

• Oversees daily manufacturing in compliance with cGMP and regulatory requirements.
• Leads Lean and Continuous Improvement initiatives across the site.
• Provides leadership to Manufacturing Managers, Supervisors and Associates.
• Represents Operations on client and internal project teams.
• Interacts with Quality, MSAT, Engineering, Supply Chain and Project Management.

Skills

Leadership

Problem solving

Communication

Team development

Strategic thinking

Education

Bachelor's degree in STEM

Job description

PCI Pharma Services seeks a Director of Manufacturing for its Bedford site to lead aseptic and non-aseptic production in line with strict quality, regulatory, and safety standards.

You will support managers and staff, drive continuous improvement, and partner with the Senior Director of Operations to plan across multiple buildings within Bedford. Strong leadership and regulatory knowledge are essential.