Associate Director, Operations
About The Position
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always, Inclusion for All” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Position Description: We are seeking an Associate Director, Operations for a capital project start-up in Durham, North Carolina. The Associate Director will oversee a portion of the manufacturing team. The facility includes end-to-end processing of drug substance, drug product, including culture growth, harvest, filling, lyophilization, product inspection, utilities, warehouse, and quality control laboratories. The Associate Director is accountable for building and leading the manufacturing team and strategy, as well as providing communication across various stakeholders to establish start-up of and execute the manufacturing process.
Requirements
- Bachelor's degree in Engineering, Science, or related field AND at least eight (8) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry OR A Master's Degree AND 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
Nice To Haves
- 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
Responsibilities
- Hiring, coaching, and developing a team of managers and technicians
- Ensure execution to schedule
- Ownership for projects and improvement
- Creating a strong safety culture
- Contributing to the manufacturing team strategy for the facility
- Directing routine process support and improvement activities
- Serving as technical SME during regulatory inspections and audits.
- Providing technical guidance for daily production, projects, deviations and changes.
- Contributing to the facility leadership team, strategy, and guiding facility operations.
- Adapts plans and priorities based on departmental budget and profit plan to address resource and operational challenges
- Decisions are guided by policies, procedures and business plan; receives guidance from manager
- Provides technical guidance to employees, colleagues or clients
- Ensure compliance to Corporate, Site, and Departmental procedures associated with the manufacturing of vaccine product, and ensuring team is trained on new or revised processes or procedures
- Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
- Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges
- Other duties as requested by Management
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Manager
