Associate Director, Drug Product
On-siteHolly Springs, North Carolina, United States
Job Summary
Create and track the Operational Readiness Plan for Drug Product manufacturing, including developing SOPs, project timelines, staffing plans, and budgets. Lead area managers and supervisors while defining business processes for formulation, aseptic filling, and visual inspection. Provide subject matter expertise on risk assessments and champion continuous improvement across operations. Manage departmental budgeting, establish KPIs, and oversee deviation investigations and CAPAs. Support a 24/7 facility with flexibility for working hours and travel up to 25%. Collaborate with FDB locations and clients to align on deliverables.
Required Qualifications
- Bachelor's Degree
- 7 years of direct Drug Product operations experience
- 10 years in the pharmaceutical industry
- Previous experience leading and developing leaders (Managers / Supervisors)
- Demonstrated experience in team management and problem solving
- Strong facilitation skills and proven leadership of cross-functional teams
- Proven track record for implementation within established deadlines
- Ability to interpret technical information and documentation used for operations and production activities
- Experience managing diverse stakeholders with strong interpersonal and influencing skills; effective communicator
- Practical, demonstrable knowledge of cGMP and compliance regulations
- Strong interpersonal skills, including the ability to negotiate and resolve challenges with diplomacy
- Support a 24/7 manufacturing facility; flexibility with working hours may be required
- Travel up to 0–25% as business needs require
Desired Qualifications
- Bachelor's degree in STEM
- 10 Years direct Drug Product with hands on experience
- Prior experience in client interface
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