Manager, Cell Therapy Manufacturing in Summit, NJ

Shift:

• Q4:
  Wed–Sat (every other Wed off), onsite night shift, 5:00 p.m.–5:30 a.m.

• Lead a Work Centered Team (WCT) executing Cell Therapy manufacturing; ensure safety, cGMP compliance, innovation, and continuous improvement.
• Ensure manufacturing execution per approved SOPs/WIs and cGMP.
• Own production records; perform batch record reviews by exception; ensure ALCOA+ compliance; resolve documentation errors.
• Perform safety Gemba walks; operate/maintain equipment safely.
• Maintain hands‑on unit operation expertise; backfill execution needs; develop CAR T manufacturing expertise.
• Manage resources: provide scheduling availability, track planned/unplanned absences, hire/retain qualified personnel aligned to values and budget.
• Set/monitor WCT goals and KPIs; report in Tier meetings.
• Ensure 100% on‑time CAR‑T GMP training compliance; qualify/disqualify personnel as needed.
• Build/develop team (Operators/Team Leads/Supervisors): interviewing, performance reviews, coaching, 1:1s, talent feedback.
• Reduce deviations; prepare No Impact deviation records; manage CAPAs/change controls/projects as needed.
• Facilitate/lead required meetings (Tier, Performance Review, daily scheduling, daily cross‑functional meeting).

• Extensive EHS and cGMP knowledge; aptitude for biotechnology/manufacturing systems.
• Lean manufacturing knowledge; excellent communication.
• 5+ years relevant manufacturing experience; 2+ years leadership with direct reports.
• Preferred:
  Bachelor’s degree (related); advanced degree.

• Cleanroom/PPE; contained human blood components; lift up to 25 lbs; controlled/enclosed lab areas.

• Summit West (NJ): $103,560–$125,495; may be eligible for incentives.
• Benefits may include medical/dental/vision/life/disability; U.S. exempt FTO and 11 paid holidays (eligibility-dependent).