Director, Manufacturing

PCI Pharma Services; Bedford (NH); On-site; USD 120,000 - 160,000; Full time

Job summary

JobRx, Inc. is seeking a Director of Manufacturing for its Bedford site. The role involves overseeing the production of aseptic and non-aseptic pharmaceuticals while ensuring compliance with quality, safety, and regulatory standards.

Applicants must have over 10 years of management experience in cGMP environments, strong leadership skills, and the ability to drive continuous improvement. Join us in making a significant impact in biopharma and enhancing patient care.

Qualifications

• 10+ years direct management experience in pharmaceuticals.
• Experience with aseptic fill/finish and lyophilized products is preferred.
• Ability to handle multiple tasks and work in a fast-paced environment.

Responsibilities

• Oversee daily manufacturing compliant with regulatory requirements.
• Responsible for cGMP compliance and documentation accuracy.
• Instill culture of Lean and Continuous Improvement.

Skills

Leadership

cGMP knowledge

Project management

Communication skills

Problem solving

Education

Bachelor's Degree in a STEM field

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective

The Director of Manufacturing for our Bedford site is responsible for the manufacturing of aseptic and non-aseptic pharmaceuticals in accordance with the most stringent quality, regulatory, and safety standards. The Director provides support to Manufacturing Managers, Supervisors, and Associates and strives for excellence and continuous improvement to further enhance site performance and client satisfaction. In conjunction with the Senior Director of Operations, provides direction as well as develops and implements medium and long‑term plans for multiple manufacturing buildings within the Bedford site.

Essential Duties and Responsibilities

• Acts as a technical expert and an escalation point for complex/high impact manufacturing issues/decisions.
• Oversees daily manufacturing of pharmaceuticals, in compliance with all corporate and regulatory requirements.
• Responsible for maintaining cGMP compliance and accuracy of all documentation related to manufacturing.
• Ensures that all production teams operate in accordance with department SOPs, which meet regulatory and cGMP standards.
• Instills a strong culture of Lean and Continuous Improvement using the site maturity index.
• Implements changes to procedures and documentation to ensure all regulatory requirements are being met.
• Responsible for management of production operations in accordance with all relevant health, safety and environmental legislation.
• Ensures safety policies and procedures are always adhered to and recommends safety improvements, as needed.
• Participates in regulatory inspections and client quality audits.
• Demonstrates substantial knowledge of industry best practices and trends of aseptic manufacturing.
• Identifies root causes of production problems and designs improvements while working within cGMP regulatory requirements.
• Leads project (client and internal) teams to represent the Operations organization.
• Accountable for identification of gaps, remediation, and developing action plans for the implementation of systems to meet short and long‑term manufacturing goals.
• Makes key decisions and formulates policies that impact strategic objectives of the department.
• Provides leadership and guidance to direct reports and project team members to develop strong leaders and support the vision of the organization.
• Writes performance reviews and oversees team development and communication by providing training, development opportunities, and guidance to staff.
• Works with direct reports to ensure adequate staffing levels are maintained.
• Other tasks as assigned by management.

Special Demands

• Ability to stand, sit, or remain in the same position for extended periods of time.
• May be required to travel between sites.
• Follow written instructions.
• Able to train others.
• Able to work in a highly complex environment with competing demands and priorities.

Qualifications

• 10+ years direct management experience with demonstrated leadership of increasing responsibility, team management, and coaching skills.
• 10+ years of experience in cGMP pharmaceutical and/or medical device manufacturing, experience in aseptic fill/finish is preferred.
• Prior experience and knowledge of a CDMO or working with CDMOs strongly preferred.
• Previous experience with lyophilized products preferred.
• Working knowledge of FDA, ICH, and EU pharmaceutical preferred.
• Bachelor's in a STEM field is required.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to work in a fast‑paced environment and handle multiple tasks simultaneously.
• The ability to develop solutions to complex problems, which require a high degree of ingenuity, reactivity, and innovativeness.
• Ability to lead other leaders in a dynamic, fast‑paced work environment.
• Honesty, integrity, respect, and courtesy with all colleagues.
• Ability to work with minimal supervision, utilizing creative and balanced independent thinking.
• Resilient through operational and organizational change.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.