• Cell Therapy Specialist

    Actalent (Frederick, MD)


    Job Title: Cell Therapy SpecialistJob Description

     

    Join a dynamic team dedicated to advancing cell therapies with transformative technologies aimed at creating new treatment options for patients with autoimmune diseases. As a Cell Therapy Specialist, you will play a pivotal role in the production of cutting-edge cell therapy products in a GMP environment.

    Responsibilities

    + Execute manufacturing batch records and standard operating procedures (SOPs) for production of clinical material.

    + Provide expert consultation on tech transfer activities to the MSAT department.

    + Develop a detailed understanding of the manufacturing process and equipment used for production.

    + Assess and resolve common problems during cell therapy product manufacturing.

    + Comply with cGMP standards and good documentation practices, review manufacturing documentation, and support internal site audits.

    + Undergo advanced training in SOPs and work instructions for cell therapy manufacturing and 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.

    + 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

    + Strong proficiency in cleanroom operations and aseptic processing.

    + Experience in batch record management and GMP production.

    + Knowledge in cell culture, biologics manufacturing process, and cell therapy production.

    + Excellent documentation skills associated with cGMP manufacturing.

    + Critical thinking, independent decision-making, and troubleshooting skills.

    Additional Skills & Qualifications

    + BS Degree in Life Sciences or Engineering.

    + 1+ years' experience in cGMP production of biologics, preferably cell therapy.

    + Sterile gowning and aseptic processing qualifications.

    Work Environment

    This role involves hands-on work setting up and operating complex equipment in a cleanroom environment. Safety, environmental, and health concerns require constant attention. Employees must adhere to company policies, rules, and regulations while handling biological materials in the cleanroom. The role requires wearing personal protective equipment such as eye protection, mask, coverall gown, gloves, and shoe covers. Expect extended periods of standing, ability to lift 30 lb., 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 12, 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 [email protected] (%[email protected]) for other accommodation options.