Sr. Manufacturing Specialist I
$98,000–$127,000 year
On-siteResearch Triangle Park, North Carolina, United States
Job Summary
Lead new product and process technology transfer programs by developing integrated site readiness plans and driving manufacturing startup activities across multiple functions. Serve as the primary operational readiness lead, managing readiness reviews, governance meetings, and action tracking to identify gaps and escalate barriers impacting execution. Coordinate critical readiness activities including change controls, equipment qualification, documentation, training, and floor support while leading complex cross-functional projects. Author and maintain manufacturing documentation with high accuracy, initiate change controls and CAPAs, and lead root cause analyses for deviations. Partner with cross-functional teams to drive continuous improvement initiatives and ensure successful product transfer to the site.
Required Qualifications
- Bachelor's degree from an accredited college or university
- At minimum 3 years of direct experience in a biotech, pharma, or an industry adjacent field
- Prior experience in biopharmaceutical or biotechnology environments with strong knowledge of cGMP regulations
- Strong root cause analysis and problem-solving experience with the ability to identify trends, investigate issues, and implement effective corrective actions
- Experience authoring, reviewing, and maintaining technical documentation, procedures, work instructions, investigations, and manufacturing records
- Intermediate to advanced skills in Microsoft Office and computer-based quality systems
- Experience in Continuous Improvement, Operational Excellence, Manufacturing Excellence, or Process Improvement programs
- Monday-Friday from 8 AM – 5 PM, standard business hours
- Shift Details: Monday-Friday from 8 AM – 5 PM, standard business hours
- This site-based role supports MFG, primarily during core weekday business hours
- may require infrequent off-hours support
Desired Qualifications
- Lean Manufacturing and/or Six Sigma training or application experience
- PMP certification or formal project management training
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