Cell Therapy Specialist
Actalent, Frederick, MD, United States
Job Title: Cell Therapy Specialist
We are seeking a dedicated and skilled Cell Therapy Specialist to join our team in a GMP environment. This role involves executing manufacturing batch records and standard operating procedures for the production of clinical material, and providing expert consultation on tech transfer activities, ensuring compliance with cGMP standards and good documentation practices.
Responsibilities
Execute manufacturing batch records and SOPs for production of clinical material.
Provide expert consultation on tech transfer activities to the MSAT department.
Understand the manufacturing process and equipment for clinical material production.
Assess and resolve common problems during cell therapy product manufacturing.
Comply with cGMP standards and support internal site audits.
Undergo advanced training in SOPs and train others as necessary.
Author and revise SOPs for cell therapy manufacturing.
Document deviations and CAPAs, investigate and resolve problems, and propose process improvements.
Ensure all manufacturing supplies are replenished and prepared for clean room use.
Assist management in ensuring a steady supply of materials by searching for alternative products and suppliers.
Essential Skills
Proficiency in cleanroom operations, batch record management, and manufacturing processes.
Experience in cell culture, aseptic processing, and GMP production.
Knowledge of biologics, cell therapy, and good documentation practices (GDP).
Additional Skills & Qualifications
BS Degree in Life Sciences or Engineering.
2+ years of experience in cGMP production of biologics, preferably cell therapy.
Strong documentation skills and ability to follow cGMP manufacturing documentation.
Critical thinking, independent decision-making, and troubleshooting skills.
Sterile gowning and aseptic processing qualifications.
Work Environment
The position involves hands‑on work in a cleanroom environment with constant attention to safety, environmental, and health concerns. It demands adherence to company policies, including wearing personal protective equipment such as eye protection, mask, gown, gloves, and shoe covers. The role involves extended periods of standing (3‑6 hours) and lifting up to 30 lb. Occasional weekend and holiday work is required. The regular shift is Wednesday through Sunday, 8:30 a.m. to 5:00 p.m., with possible weekend work once a month on a volunteer basis.
Position Details
Job Type: Contract – 6 month contract
Location: Frederick, MD
Workplace Type: Fully onsite
Pay Range: $31.25 – $43.00 per hour
Application Deadline: April 30, 2026
Benefits
Eligible employees may receive benefits including medical, dental & vision; critical illness, accident, and hospital; 401(k) retirement plan; life insurance; disability; health spending account; transportation benefits; employee assistance program; and time off/leave.
Actalent is an equal opportunity employer.
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We are seeking a dedicated and skilled Cell Therapy Specialist to join our team in a GMP environment. This role involves executing manufacturing batch records and standard operating procedures for the production of clinical material, and providing expert consultation on tech transfer activities, ensuring compliance with cGMP standards and good documentation practices.
Responsibilities
Execute manufacturing batch records and SOPs for production of clinical material.
Provide expert consultation on tech transfer activities to the MSAT department.
Understand the manufacturing process and equipment for clinical material production.
Assess and resolve common problems during cell therapy product manufacturing.
Comply with cGMP standards and support internal site audits.
Undergo advanced training in SOPs and train others as necessary.
Author and revise SOPs for cell therapy manufacturing.
Document deviations and CAPAs, investigate and resolve problems, and propose process improvements.
Ensure all manufacturing supplies are replenished and prepared for clean room use.
Assist management in ensuring a steady supply of materials by searching for alternative products and suppliers.
Essential Skills
Proficiency in cleanroom operations, batch record management, and manufacturing processes.
Experience in cell culture, aseptic processing, and GMP production.
Knowledge of biologics, cell therapy, and good documentation practices (GDP).
Additional Skills & Qualifications
BS Degree in Life Sciences or Engineering.
2+ years of experience in cGMP production of biologics, preferably cell therapy.
Strong documentation skills and ability to follow cGMP manufacturing documentation.
Critical thinking, independent decision-making, and troubleshooting skills.
Sterile gowning and aseptic processing qualifications.
Work Environment
The position involves hands‑on work in a cleanroom environment with constant attention to safety, environmental, and health concerns. It demands adherence to company policies, including wearing personal protective equipment such as eye protection, mask, gown, gloves, and shoe covers. The role involves extended periods of standing (3‑6 hours) and lifting up to 30 lb. Occasional weekend and holiday work is required. The regular shift is Wednesday through Sunday, 8:30 a.m. to 5:00 p.m., with possible weekend work once a month on a volunteer basis.
Position Details
Job Type: Contract – 6 month contract
Location: Frederick, MD
Workplace Type: Fully onsite
Pay Range: $31.25 – $43.00 per hour
Application Deadline: April 30, 2026
Benefits
Eligible employees may receive benefits including medical, dental & vision; critical illness, accident, and hospital; 401(k) retirement plan; life insurance; disability; health spending account; transportation benefits; employee assistance program; and time off/leave.
Actalent is an equal opportunity employer.
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