Cell Management Specialist
delan-associates-inc
Job description
About the role
The Cell Management Specialist supports core manufacturing functions at our Morris Plains facility. The role involves handling apheresis receipt, final product packaging, day‑0 and harvest transfers, and inventory management while ensuring compliance with cGMP standards.
Key responsibilities
- Follow SOPs, work procedures and batch records with a focus on Right First‑Time performance.
- Enter data promptly and accurately; maintain audit‑ready manufacturing support areas.
- Perform equipment cleaning and maintenance per SOP requirements.
- Escalate and help resolve compliance or safety issues.
- Support monthly and annual cycle counts and inventory accuracy in SAP/MES.
- Receive, inspect, package, and ship leukapheresis products; coordinate day‑0 apheresis delivery.
- Harvest, store, and track final products; manage LN2 storage locations.
- Participate in site projects and initiatives while adhering to company values.
Required profile
- 1‑3 years of experience in a cGMP/FDA‑regulated environment (warehouse experience preferred).
- High school diploma required; bachelor’s degree preferred.
- Strong written and verbal communication, problem‑solving and follow‑up abilities.
- Well‑organized, flexible and able to work with minimal supervision.
- Ability to lift up to 50 lb and handle chemicals, solvents and bio‑hazardous materials.
Required skills
- Proficiency with LIMS.
- Experience using SAP.
- Experience using MES.
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Published 3 weeks ago
Expires 1 month from now
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delan-associates-inc
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