Director, Manufacturing

PCI NH Lyophilization Services of New England; Bedford (NH); Presencial; USD 180.000 - 260.000; Jornada completa

Descripción de la vacante

PCI Pharma Services in Bedford, NH seeks a Director of Manufacturing to lead aseptic and non-aseptic production, ensuring strict cGMP compliance and flawless documentation. You will guide Manufacturing Managers, Supervisors, and Associates, driving Lean and Continuous Improvement across the Bedford site and coordinating with the Senior Director of Operations on long-term plans for multiple buildings.

You will influence safety culture, regulatory readiness, and client satisfaction by solving

Formación

• 10+ years direct management experience with demonstrated leadership.
• 10+ years of cGMP pharmaceutical manufacturing experience, aseptic fill/finish preferred.
• Prior CDMO experience and knowledge strongly preferred.
• A B.S. in a STEM field is required.
• Excellent written, verbal, and interpersonal communication skills.
• Knowledge of FDA/ICH/EU regulatory expectations.

Responsabilidades

• Acts as a technical expert and escalation point for complex/high impact manufacturing issues.
• Oversees daily manufacturing in compliance with corporate and regulatory requirements.
• Maintains cGMP compliance and accuracy of manufacturing documentation.
• Drives Lean and Continuous Improvement across the site.
• Leads project teams and develops action plans to meet goals.

Conocimientos

Leadership

People management

cGMP experience

Aseptic fill/finish

CDMO experience

Regulatory knowledge

Communication

Problem solving

Change management

Educación

B.S. in a STEM field

Herramientas

Lyophilized products

Descripción del empleo

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.

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.