Director of Operations

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

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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 Operations for our Madison, Wisconsin site is responsible for the manufacturing of aseptic pharmaceuticals in accordance with the most stringent quality, regulatory and safety standards. The Director provides support to manufacturing supervisors and associates and strives for excellence and continuous improvement to further enhance the sites' performance and client satisfaction. In conjunction with the General Manager, provides direction as well as develops and implements medium- and long-term plans.

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 departments operate in accordance with department SOPs which meet regulatory and cGMP standards
• 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 adhered to at all times. Recommends safety improvements, as necessary
• Participates in regulatory inspections and client quality audits
• Demonstrates substantial knowledge of industry best practices and trends of aseptic manufacturing practices
• Identifies root causes of production problems and recommends improvements while working within cGMP regulatory requirements
• Leads or participates on 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 to develop strong leaders and support the vision of the organization
• Leads Operations personnel, including organizing and prioritizing group tasks
• 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.

• Must be able to gown appropriately
• Must prioritize, organize, and successfully manage multiple assignments concurrently.
  

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Works closely with internal operation teams
• Interacts with all departmental staff and other departments at all levels
• Must be comfortable presenting technical and complex issues clearly to all levels of management as well as client representatives
• Management of 5 or more direct reports across multiple sites, some will have managerial responsibility
• TRAVEL - < 10%

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.

• B.S. in Science, Chemistry or Engineering, or equivalent
• 10+ years' direct management experience with demonstrated leadership, team management and coaching skills. Demonstration of increasing responsibilities.
• 10+ years of experience in cGMP pharmaceutical manufacturing is preferred
• Prior experience and knowledge of a CMO or dealing with CMOs strongly preferred
• Extensive knowledge in aseptic fill/finish preferred
• Previous experience with lyophilized products preferred
• Working knowledge of FDA, ICH and EU pharmaceutical and/or medical device requirements, experience with both preferred
• Excellent written and 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 others in a dynamic, fast paced work environment
• Honesty, integrity, respect and courtesy with all colleagues
• Creative with the ability to work with minimal supervision and balanced with 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.