Lead, Manufacturing (Days)
$68,994–$90,002 year
On-siteResearch Triangle Park, North Carolina, United States
Job Summary
Execute manufacturing processing steps and monitor processes against batch records, SLRs, and control systems in a cGMP environment. Coordinate shift tasks and resource allocation for production, validation, or project activities while leading process steps as an expert. Document and review cGMP data, including deviations, following standard operating procedures, and initiate investigations to develop corrective and preventative actions. Provide technical guidance, troubleshooting support, and real-time decision-making to associates during assigned 12-hour day shifts on a 2-2-3 calendar rotation. Lead training activities, observe employee performance, and offer targeted coaching. Serve as the operational point of contact and SME for audits.
Required Qualifications
- 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET)
- Black Days rotating schedule
- Bachelor's degree from an accredited college or university, STEM preferred
- at minimum 4 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred
- at minimum 4.5 year of direct experience
- A High School Diploma (or equivalent)
- at minimum of 5 years of direct experience
- Demonstrated experience leading manufacturing activities, coordinating work across a shift team, and training associates in a cGMP environment
- Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
- Experience working in an aseptic or cleanroom environment
- Experience supporting downstream manufacturing operations and/or buffer preparation processes in a cGMP manufacturing environment
- Experience with Trackwise, Delta V, Syncade, LIMS, and/or similar systems
Desired Qualifications
- Prior buffer preparation or downstream experience in a leadership capacity
- Lean, Six Sigma and 5S certifications
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