Associate Director, Operations
$129,000–$203,100 year
On-siteDurham, North Carolina, United States
Job Summary
Oversee a portion of the manufacturing team for a capital project start-up, including hiring, coaching, and developing managers and technicians. Direct routine process support and improvement activities while ensuring execution to schedule and ownership for projects. Provide technical guidance for daily production, projects, deviations, and changes, and serve as the technical SME during regulatory inspections and audits. Adapt plans and priorities based on departmental budget and profit plan to address resource and operational challenges, ensuring compliance to Corporate, Site, and Departmental procedures. Collaborate with peers to resolve cross-unit operational problems and contribute to the facility leadership team strategy.
Required Qualifications
- Bachelor's degree in Engineering, Science, or related field
- At least eight (8) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry
- Master's Degree
- At least six (6) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry
- Routine commercial manufacturing experience
- Direct and/or indirect leadership experience of teams and/or projects, including coaching and developing people
- Strong communication skills with the ability to present complex data sets to diverse audience with varying business acumen
- Demonstrated technical expertise during regulatory inspections and audits
- Demonstrated project management and analytical skills
- Valid Driving License
Desired Qualifications
- Experience with Good Manufacturing Practice (GMP) operations, tech transfer, capital projects, facility start-up, production, and improvement projects
- Strategic, end-to-end thinking
- Experience in regulated or GMP manufacturing and/or technical support of manufacturing operations
- Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and supporting clean utilities
- Familiarity with change control systems and technical assessment of change in a current GMP production environment
- Experience with sterile processing and sterility assurance practices and guidelines
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.