Director, Manufacturing

PCI Pharma Services•Bedford, NH

About The Position

The Director of Manufacturing for PCI’s Bedford site is responsible for manufacturing aseptic and non-aseptic pharmaceuticals in accordance with stringent quality, regulatory, and safety standards. The Director supports Manufacturing Managers, Supervisors, and Associates and promotes excellence and continuous improvement to enhance site performance and client satisfaction. In conjunction with the Senior Director of Operations, the Director provides direction and develops and implements medium- and long-term plans for multiple manufacturing buildings within the Bedford site. The position serves as a technical expert and escalation point for complex or high-impact manufacturing issues and decisions. It oversees daily manufacturing operations, maintains cGMP compliance and accurate manufacturing documentation, and ensures production teams follow department SOPs and applicable regulatory standards. The Director leads operational improvement, safety, inspection readiness, remediation, and planning activities, and provides leadership, development, and guidance to direct reports and project teams. The role manages four or more direct reports across multiple sites, some of whom have managerial responsibility. It works closely with internal operations teams and interacts with Quality, MSAT, Engineering, Supply Chain, Project Management, and other departments, as well as client representatives. Travel is less than 10%.

Requirements

At least 10 years of direct management experience, including demonstrated leadership of increasing responsibility, team management, and coaching skills.
At least 10 years of experience in cGMP pharmaceutical and/or medical device manufacturing.
Bachelor of Science degree in a STEM field.
Excellent written, verbal, and interpersonal communication skills.
Ability to work in a fast-paced environment and handle multiple tasks simultaneously.
Ability to develop solutions to complex problems requiring ingenuity, reactivity, and innovation.
Ability to lead other leaders in a dynamic, fast-paced work environment.
Demonstrate honesty, integrity, respect, and courtesy with colleagues.
Ability to work with minimal supervision and use creative, balanced independent thinking.
Resilience through operational and organizational change.

Nice To Haves

Aseptic fill/finish manufacturing experience.
Prior experience with or knowledge of a CDMO, or working with CDMOs.
Experience with lyophilized products.
Working knowledge of FDA, ICH, and EU pharmaceutical requirements.

Responsibilities

Act as a technical expert and escalation point for complex or high-impact manufacturing issues and decisions.
Oversee daily pharmaceutical manufacturing in compliance with corporate and regulatory requirements.
Maintain cGMP compliance and the accuracy of manufacturing documentation.
Ensure production teams operate in accordance with department SOPs and regulatory and cGMP standards.
Promote a strong Lean and continuous-improvement culture using the site maturity index.
Implement changes to procedures and documentation to meet regulatory requirements.
Manage production operations in accordance with applicable health, safety, and environmental legislation.
Ensure safety policies and procedures are followed and recommend safety improvements as needed.
Participate in regulatory inspections and client quality audits.
Apply knowledge of industry best practices and trends in aseptic manufacturing.
Identify root causes of production problems and develop improvements within cGMP requirements.
Lead client and internal project teams representing Operations.
Identify gaps, lead remediation, and develop action plans to implement systems supporting short- and long-term manufacturing goals.
Make key decisions and formulate policies affecting the department’s strategic objectives.
Provide leadership and guidance to direct reports and project team members, developing leaders and supporting the organization’s vision.
Write performance reviews and oversee staff development and communication through training, development opportunities, and guidance.
Work with direct reports to maintain adequate staffing levels.
Work closely with internal operations teams and coordinate with Quality, MSAT, Engineering, Supply Chain, Project Management, and other departments.
Present technical and complex issues clearly to management at all levels and to client representatives.
Manage four or more direct reports across multiple sites, including some with managerial responsibilities.
Perform other tasks as assigned by management.