Director, Manufacturing

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

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.
• Instill 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.
• Works closely with internal operations teams.
• Interacts with all departmental staff and other departments at all levels, including: Quality, MSAT, Engineering, Supply Chain, and Project Management.
• Must be comfortable presenting technical and complex issues clearly to all levels of management as well as client representatives.
• Management of 4 or more direct reports across multiple sites, some will have managerial responsibility.
• TRAVEL = <10%

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.
• A B.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.

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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.