Manufacturing Lead, cGMP (Days)
Overview
Lead daily cGMP manufacturing operations on a 2-2-3 days rotation (6 AM-6 PM ET), owning process execution and documentation. Coordinate with the shift Supervisor to schedule tasks, allocate resources, and ensure real-time compliance. Coach associates, investigate deviations, and serve as the operational point of contact for your shift. This role is a proven path to Manufacturing Supervisor, with exposure to Trackwise, Delta V, Syncade, and LIMS. You'll drive output for a 24/7 biomanufacturing site, directly impacting life-saving therapies.
What You'll Do9
- 1Execute manufacturing steps and support activities, monitoring processes against batch records and control systems.
- 2Coordinate with the shift Supervisor to schedule tasks, allocate resources, and balance production, validation, and project activities.
- 3Document and review cGMP data, including deviations, and ensure real-time completeness of BPR and SLR.
- 4Revise batch records, SLRs, and equipment logbooks to reflect current procedures.
- 5Manage your personal training plan and train other associates, sharing knowledge across the shift.
- 6Observe employee performance, provide targeted coaching, and give feedback to the Supervisor for mid-year and year-end reviews.
- 7Initiate and investigate deviations, developing and implementing corrective and preventative actions as directed.
- 8Lead troubleshooting efforts and serve as a Subject Matter Expert (“SME”) during audits.
- 9Act as the operational point of contact for associates during shifts, offering technical guidance and real-time decision-making.
Requirements6
- 14+ years of direct cGMP manufacturing experience with a Bachelor's degree (STEM preferred) or 4.5+ years with a BioWorks Certificate or associate's degree, or 5+ years with a High School Diploma.
- 2Demonstrated experience leading manufacturing activities, coordinating shift teams, and training associates in a cGMP environment.
- 3Ability to follow SOPs and adhere to GDP.
- 4Experience in an aseptic or cleanroom environment.
- 5Experience supporting downstream manufacturing or buffer preparation in cGMP.
- 6Working knowledge of Trackwise, Delta V, Syncade, LIMS, or similar systems.
Salary Insight
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