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Manager, Manufacturing Sciences
On-site · Greenville, North Carolina, United States
Job Summary
Provides technical and administrative managerial leadership to the Steriles Technical Support group by leading organizational change, developing staff, budgeting and hiring to meet operational needs, conducting performance reviews, and ensuring on-time completion of Deviations, CAPA’s, Work Order Updates, SOP revisions, and audit responses. Serves as a subject matter expert for sterile operations, guides regulatory interactions (FDA/USP), and supports strategic plans to grow the business with existing and potential customers through technology transfer and strong cross-functional collaboration.
Required Qualifications
- Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science
- Three (3) years of leadership/supervisory experience
- Five (5) years of dynamic experience within Sterile Pharmaceutical environment
- Knowledge in GMP’s and FDA regulations
- Strong decision making skills
- Excellent verbal and technical written communication skills
- Ability to establish and maintain effective working relationships with employees
- Ability to resolve issues independently, and to engage others as needed in a productive / constructive manner
- Comprehensive knowledge of sterile production operations
- Experience working on broad multidisciplinary teams and/or groups
- Outstanding attention to detail
- Self-starter, mature, and independent
- Strong computer/ software skills (i.e. Outlook, Excel, Word, PowerPoint)
- Experience leading technical and administrative aspects of a sterile manufacturing group
- Ability to manage performance plans, job descriptions, and employee performance reviews
- Experience or familiarity with Deviations, CAPA, Work Orders, SOP revisions, and regulatory responses
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