Manager, Cell Therapy Manufacturing in Summit, NJ

Scorpion Therapeutics; Summit (NJ); On-site; USD 104,000 - 125,000; Full time

Benefits offered by this job

Medical/dental/vision

11 paid holidays

U.S. exempt FTO

Job summary

Scorpion Therapeutics in Summit, NJ, is seeking a Shift Lead for CAR-T cell therapy manufacturing. This onsite night shift runs 5:00 p.m.–5:30 a.m., Wed–Sat with every-other-Wed off.

You will lead a Work Centered Team, ensure cGMP compliance, and own batch records while driving safety and continuous improvement. You will backfill hands-on operations, develop CAR-T expertise, and align resources to budget and values.

Qualifications

• Extensive EHS and cGMP knowledge.
• Lean manufacturing knowledge; strong communication skills.
• 5+ years manufacturing experience; 2+ years in leadership with direct reports.

Responsibilities

• 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: scheduling availability, track absences, hire/retain 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: interviewing, performance reviews, coaching, 1:1s, talent feedback.
• Reduce deviations; prepare No Impact deviation records; manage CAPAs/change controls/projects.
• Facilitate/lead required meetings (Tier, Performance Review, daily scheduling, daily cross-functional).

Skills

Leadership

Lean manufacturing

Communication

cGMP knowledge

Education

Bachelor’s degree (related)

Advanced degree (preferred)

Job description

Shift:

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

Responsibilities:

• 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).

Qualifications / Skills:

• 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.

Working conditions:

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

Compensation/Benefits (as stated):

• 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).