Lead Cell Therapy Specialist

In this role, you will lead and coordinate daily manufacturing execution, ensuring personnel, materials, equipment, documentation, and cleanroom areas are ready before operations begin. You will drive right first time execution by providing real-time technical mentorship, coaching, and troubleshooting support during production runs. This position also plays a significant role in maintaining schedule adherence, supporting shift handovers, advancing risks in real time, and partnering cross-functionally with Manufacturing, Quality, MSAT, Process Development, Supply Chain, and Facilities and Engineering. You’ll also support training, deviation investigations, CAPAs, process documentation updates, and continuous improvement efforts that help strengthen operational readiness and future commercial success.
 

Minimum Requirements

• Education and experience: High School Diploma with at least 5 years of relevant cell therapy, pharmaceutical, biotech, or GMP manufacturing experience, or a Bachelor’s degree with at least 3 years of relevant experience
• GMP experience: Experience working in a cGMP manufacturing environment
• Technical skills: Experience with aseptic technique, cleanroom behavior, cell culture operations, and single-use technologies
• Leadership capability: Proven ability to lead work on the manufacturing floor and guide team members during execution
• Documentation and quality knowledge: Strong understanding of SOPs, batch records, production records, and quality systems
• Problem escalation: Ability to recognize deviations from accepted practice and advance appropriately
• Communication: Strong written and verbal communication skills
• Work style: Strong attention to detail, accountability, and ability to thrive in a regulated, fast-paced, and changing manufacturing environment
• Collaboration: Skilled at working effectively across Manufacturing, Quality, MSAT, Process Development, Supply Chain, and Facilities and Engineering

Working Conditions

• Cleanroom environment: Ability to work in a cleanroom environment requiring gowning
• Physical demands:Ability to stand for extended periods and perform repetitive movements, reaching, bending, and careful handling of materials or equipment
• Lifting and handling: Required to carry and lift up to 30 pounds daily and push or pull up to 50 pounds daily
• Specialized environments: May work around strong magnets, niche manufacturing equipment, human blood products, biological materials, vapor phase liquid nitrogen, or cryogenic materials
• Schedule flexibility: Ability to work assigned shifts, weekends, holidays, and overtime as the need arises by the manufacturing schedule
• Compliance expectations: Must follow all safety, contamination control, gowning, documentation, and cGMP requirements

Preferred Background

• Cell therapy expertise: Priority experience in cell therapy manufacturing
• Manufacturing readiness: Experience supporting technology transfer and GMP clinical or commercial manufacturing operations
• Training and coaching: Experience training or mentor team members in GMP processes
• Quality systems support: Experience supporting deviation investigations, CAPAs, change controls, SOP revisions, or batch record improvements
• Systems familiarity: Experience with paper and electronic batch records, manufacturing execution systems, inventory systems, or quality management systems
• Decision-making: Proven ability to make timely decisions, manage competing priorities, and know when to intensify
• Independence: Able to work with minimal direction while setting daily priorities for self and others

Ready to make an impact in sophisticated cell therapy manufacturing? Apply today and help lead the execution, quality, and teamwork that bring innovative therapies closer to patients.
 

The annual base pay (or hourly rate of compensation) for this position ranges from $XX to $XX. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.