Senior Cell Therapy Manufacturing Specialist

Kincell Bio; Gainesville (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

Kincell Bio seeks an Associate III for our Gainesville, FL manufacturing team to operate cell therapy equipment following SOPs and MBRs. You will perform complex GMP steps, support in-process analyses, and ensure right-the-first-time execution.

You will mentor junior staff, contribute to deviations, CAPAs, and training curricula, and collaborate with QA, MSAT, and engineering to maintain compliance and readiness for campaigns.

Qualifications

• Experience leading GMP manufacturing operations independently.
• Ability to manage deviations, CAPAs, and change controls with QA partnership.
• Strong documentation and cross-functional collaboration skills.

Responsibilities

• Independently execute and oversee complex GMP manufacturing operations on the floor.
• Lead high-risk manufacturing steps, aseptic manipulations, and fill activities.
• Mentor and train Manufacturing Associates; support onboarding and readiness.
• Prepare and review technical documentation, deviations, CAPAs, and changes.
• Collaborate with QA, MSAT, Engineering, and QC to ensure readiness.

Skills

GMP manufacturing

Process optimization

Excel / MS Office

Deviation management

Training / mentoring

Aseptic techniques

Quality systems

Cross-functional collaboration

Education

Bachelor's Degree in Life Sciences or Engineering

Associate's Degree in Life Sciences/Engineering

High School Diploma with GMP experience

Tools

MS Excel

Veeva Vault / QMS tools

Documentation systems

Job description

Kincell Bio seeks an Associate III for our Gainesville, FL manufacturing team to operate cell therapy equipment following SOPs and MBRs. You will perform complex GMP steps, support in-process analyses, and ensure right-the-first-time execution.

You will mentor junior staff, contribute to deviations, CAPAs, and training curricula, and collaborate with QA, MSAT, and engineering to maintain compliance and readiness for campaigns.