Supervisor, Manufacturing (Cell Therapy)

Location: Bridgewater, New Jersey, United States; on-site

Salary: $90,000–$210,000 per year

Company

hirify.global develops and operates integrated technologies and Smart Factories for automated, high-throughput cell therapy manufacturing.

What you will do

• Lead, coach, and develop the manufacturing team responsible for clinical and commercial production of autologous and allogeneic cell therapy products.
• Oversee engineering runs, PPQ, APS, aseptic technique, process execution, and compliant operations in R&D and GMP environments.
• Coordinate cross-functional work with Quality, MSAT, QC, Process Development, Supply Chain, Engineering, Facilities, Validation, and other groups.
• Review production documentation and manage production records, SOPs, protocols, SAP material issuance, deviations, CAPAs, and change controls.
• Prepare schedules, assign work, manage training status, and oversee hiring, development, and performance management.
• Drive improvements in safety, quality, compliance, cost, delivery, people, technical problem-solving, technology transfer, qualification, and validation.

Requirements

• Bachelor’s degree in science, engineering, or a related field.
• 6+ years of operations experience in a cGMP biotech or biopharma environment, including at least 3 years of leadership experience.
• Required experience in cell or gene therapy; experience with tech transfer, process validation, and change management.
• Direct experience interacting with the FDA and other regulatory agencies, with substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO, and related standards.
• Experience managing GMP manufacturing operations, delivering quality products on schedule, and building high-performing teams.
• Strong analytical, problem-solving, communication, organizational, teamwork, and interpersonal skills.

Nice to have

• CDMO experience.
• Operational Excellence or Lean Manufacturing experience.
• Lean Six Sigma certification.

Culture & Benefits

• Fast-paced, mission-driven environment focused on expanding access to cell therapies.
• Highly subsidized medical, dental, and vision plans.
• 401(k) matching.
• On-site lunches and stock options.
• Work in a commercial-scale Smart Factory and multidisciplinary manufacturing organization.