Reporting to the Chief Operating Officer (COO), the Director, Manufacturing oversees all GMP Manufacturing Operations with a focus on aseptic processing in a CDMO environment. The Director will lead sterile manufacturing processes, ensuring day-to-day operational excellence, compliance, and quality within Aseptic Formulation, Filling Operations, Inspection, Packaging, and Serialization.
ESSENTIAL DUTIES & RESPONSIBILITIES - Lead and manage multidisciplinary teams in aseptic manufacturing, ensuring effective recruitment, coaching, and retention of top talent.
- Communicate departmental goals and performance expectations to staff, providing regular feedback and development opportunities.
- Oversee daily production activities for aseptic formulation, filling, inspection, and packaging operations, maintaining strict quality and safety standards.
- Collaborate with cross-functional teams including Engineering, Quality, Process Development, Validation, Metrology, Materials Management, and Regulatory Affairs on project execution and operational improvement.
- Ensure compliance with relevant global GMP regulations, championing a culture of good manufacturing practices within all manufacturing areas.
- Drive implementation and maintenance of standard operating procedures (SOPs) for all aspects of aseptic manufacturing operations.
- Partner with Project Management to optimize production schedules, facility utilization, and workforce planning to achieve maximum efficiency and throughput.
- Participate as manufacturing subject matter expert (SME) on internal project teams and support client engagement as required.
- Support the evaluation and implementation of new manufacturing technologies and continuous improvement initiatives to enhance productivity, compliance, and product quality.
- Maintain proper staff training and readiness in aseptic manufacturing operations.
- Monitor and proactively address operational risks, ensuring business continuity and meeting customer commitments.
- Manage operating budgets, ensuring effective use of resources for manufacturing activities.
QUALIFICATIONS - Bachelor’s Degree in Science, Engineering, or related discipline; Master’s preferred.
- 8+ years of experience in pharmaceutical manufacturing within aseptic fill/finish operations, with at least 5 years in a leadership or management capacity in a GMP/CDMO environment.
- Strong experience with Quality Systems and supporting successful regulatory inspections (FDA, EMA, etc.).
- Proven track record in lean manufacturing and continuous improvement initiatives.
- Excellent communication, interpersonal, and cross-functional collaboration skills.
- Demonstrated technical understanding of aseptic processing, commercial-scale production, and GMP compliance.
- Experience writing, reviewing, and implementing SOPs and regulatory documents related to aseptic manufacturing.
- Ability to work effectively both independently and within teams to drive operational excellence.
KNOWLEDGE, SKILLS, & ABILITIES - Deep working knowledge of aseptic and sterile manufacturing practices.
- Hands-on leadership of teams performing formulation, component preparation, sterilization, filling, lyophilization, terminal sterilization, visual inspection, labeling, cartoning, and serialization.
- Ability to train, mentor, and develop manufacturing staff, fostering a culture of accountability and continuous improvement.
- Experience with technology transfer, scale-up, and supporting regulatory submissions related to manufacturing.
- Commitment to full GMP compliance and application of latest industry best practices.
- Capacity to contribute to construction, qualification, and startup activities for expanded manufacturing spaces.
- Technical depth in aseptic manufacturing processes
- Operational and project management skills
- Leadership and people development
- Strong regulatory and compliance knowledge
- Collaborative and results-driven work style
- Effective communicator across all organizational levels
PHYSICAL REQUIREMENTS - Prolonged periods sitting at a desk and working on a computer
- Ability to lift up to 50 pounds as required
