Director, Manufacturing

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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• 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.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• 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: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.

• Bachelors 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.

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.