Director, Manufacturing

• ◆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

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+ 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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