Actalent
Cell Therapy Specialist
Join a pioneering team dedicated to reimagining cell therapies with transformative technologies, offering new treatment options for patients with autoimmune diseases. Contribute to the complex manufacturing of cutting-edge cell therapy products, and be part of the journey towards developing potent yet safer therapies. Responsibilities
Execute manufacturing batch records and standard operating procedures (SOPs) for production of clinical material as part of a team in a GMP environment. Provide expert consultation on tech transfer activities to the MSAT department. Maintain a detailed understanding of the manufacturing process and the equipment used for production of clinical material. Assess and resolve common problems during cell therapy product manufacturing. Comply with cGMP standards and good documentation practices; timely review executed manufacturing documentation and support internal site audits for compliance. Undergo advanced training in required SOPs and work instructions for cell therapy manufacturing; train others when necessary. Author and revise SOPs as necessary for cell therapy manufacturing. Document deviations and CAPAs, investigate and resolve problems, identify root cause, and propose process improvements through clear communication to senior leadership. Ensure that all supplies for manufacturing are replenished and prepared for use in the clean room environment. Assist management with ensuring a steady supply of materials by actively searching for alternative products and suppliers. Essential Skills
Cell culture Aseptic processing Cell therapy or biologics manufacturing GMP production Excellent documentation skills with a focus on cGMP manufacturing Additional Skills & Qualifications
BS Degree in Life Sciences or Engineering 2+ years' experience in cGMP production of biologics, preferably with cell therapy experience Significant knowledge in biologics manufacturing process, cell culture, and/or cell therapy production Ability to apply critical thinking, independent decision-making, high attention to detail, and troubleshooting skills to complex manufacturing issues Sterile gowning and aseptic processing qualifications in previous positions Work Environment
This position involves hands-on work setting up and operating complex equipment in a cleanroom environment. Safety, environmental, and health concerns demand constant attention, requiring strict adherence to company policies, rules, and regulations. The role involves handling biological materials, necessitating the use of personal protective equipment, including eye protection, mask, coverall gown, gloves, and shoe covers. The position requires extended periods of standing in a clean room, up to 3-6 hours at a time, the ability to lift 30 lbs., and occasional weekend and holiday work. Pay and Benefits
The pay range for this position is $31.25 - $43.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan
Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type
This is a fully onsite position in Frederick, MD. Application Deadline
This position is anticipated to close on Aug 15, 2025. About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actALENTaccommodation@actalentservices.com for other accommodation options.
Join a pioneering team dedicated to reimagining cell therapies with transformative technologies, offering new treatment options for patients with autoimmune diseases. Contribute to the complex manufacturing of cutting-edge cell therapy products, and be part of the journey towards developing potent yet safer therapies. Responsibilities
Execute manufacturing batch records and standard operating procedures (SOPs) for production of clinical material as part of a team in a GMP environment. Provide expert consultation on tech transfer activities to the MSAT department. Maintain a detailed understanding of the manufacturing process and the equipment used for production of clinical material. Assess and resolve common problems during cell therapy product manufacturing. Comply with cGMP standards and good documentation practices; timely review executed manufacturing documentation and support internal site audits for compliance. Undergo advanced training in required SOPs and work instructions for cell therapy manufacturing; train others when necessary. Author and revise SOPs as necessary for cell therapy manufacturing. Document deviations and CAPAs, investigate and resolve problems, identify root cause, and propose process improvements through clear communication to senior leadership. Ensure that all supplies for manufacturing are replenished and prepared for use in the clean room environment. Assist management with ensuring a steady supply of materials by actively searching for alternative products and suppliers. Essential Skills
Cell culture Aseptic processing Cell therapy or biologics manufacturing GMP production Excellent documentation skills with a focus on cGMP manufacturing Additional Skills & Qualifications
BS Degree in Life Sciences or Engineering 2+ years' experience in cGMP production of biologics, preferably with cell therapy experience Significant knowledge in biologics manufacturing process, cell culture, and/or cell therapy production Ability to apply critical thinking, independent decision-making, high attention to detail, and troubleshooting skills to complex manufacturing issues Sterile gowning and aseptic processing qualifications in previous positions Work Environment
This position involves hands-on work setting up and operating complex equipment in a cleanroom environment. Safety, environmental, and health concerns demand constant attention, requiring strict adherence to company policies, rules, and regulations. The role involves handling biological materials, necessitating the use of personal protective equipment, including eye protection, mask, coverall gown, gloves, and shoe covers. The position requires extended periods of standing in a clean room, up to 3-6 hours at a time, the ability to lift 30 lbs., and occasional weekend and holiday work. Pay and Benefits
The pay range for this position is $31.25 - $43.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan
Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type
This is a fully onsite position in Frederick, MD. Application Deadline
This position is anticipated to close on Aug 15, 2025. About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actALENTaccommodation@actalentservices.com for other accommodation options.