Lead, Manufacturing - Solution Prep

Shift Details:

• 2-2-3 calendar rotation on days (6:00 AM–6:00 PM ET)

The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operating process equipment, executing validation protocols, revising cGMP documents, ensuring cGMP compliance, and maintaining equipment and facilities. Works closely with the shift Supervisor; serves as a key preparatory role for Manufacturing Supervisor.

• Execute manufacturing processing steps/support activities; monitor against batch record, SLR, and control system; coordinate/lead as process step expert.
• In coordination with Supervisor: schedule shift tasks, plan resource allocation (production/validation/projects), ensure proper information sharing at shift exchange, and communicate issues.
• Document/record and review cGMP data; document deviations; develop/revise documents (batch records, SLRs, equipment logbooks); ensure BPR/SLR real-time review completeness.
• Participate in training; manage individual training plan; train others; coach and provide feedback to Supervisor.
• Initiate/investigate deviations; develop/implement CAPAs; lead/participate in troubleshooting; serve as possible SME for audits.
• Serve as operational point of contact during assigned shifts for technical guidance and real-time decisions.

• Bachelor’s (STEM preferred) + 4 years; or Bio Works certificate/associate’s (STEM) + 4.5 years; or HS (or equivalent) + 5 years.
• Leading manufacturing activities; coordinating across shift team; training in cGMP.
• Follow SOPs and GDP.
• Aseptic/cleanroom experience.
• Downstream/buffer prep experience in cGMP.
• Trackwise, Delta V, Syncade, LIMS (or similar).

• Leadership experience in buffer prep/downstream.
• Lean, Six Sigma, 5S certifications.

• Medical, dental, vision, life; fitness reimbursement; short-/long-term disability; paid vacation (min 15 days) plus Dec 26–Dec 31 shutdown; holidays and paid personal days; sick time; paid maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year;
  Employee Resource Groups participation.