Job Description
Join a pioneering team dedicated to reimagining cell therapies with transformative technologies aimed at developing new treatment options for patients with autoimmune diseases. As a Cell Therapy Specialist, you will be part of a dynamic team working in a state-of-the-art GMP environment. You will execute manufacturing batch records and standard operating procedures to produce clinical material, while ensuring compliance with cGMP standards and good documentation practices.
ResponsibilitiesExecute manufacturing batch records and standard operating procedures for clinical material production.Provide expert consultation on tech transfer activities to the MSAT department.Understand the manufacturing process and equipment used for clinical material production.Assess and resolve common problems during cell therapy production.Comply with cGMP standards and good documentation practices; review executed manufacturing documentation.Support internal site audits for compliance.Undergo advanced training in SOPs and work instructions; train others as needed.Author and revise SOPs for cell therapy manufacturing.Document deviations and CAPAs, investigate and resolve problems, identify root causes, and propose process improvements.Ensure supplies for manufacturing are replenished and prepared for use in the cleanroom environment.Assist management in maintaining a steady supply of materials by seeking alternative products and suppliers.Essential SkillsProficiency in GMP, cleanroom operations, and batch record management.Experience in manufacturing, cell culture, aseptic processing, cell therapy, or biologics.Ability to apply critical thinking and independent decision-making.High attention to detail and excellent troubleshooting skills.Sterile gowning and aseptic processing qualifications.Additional Skills & QualificationsBS Degree in Life Sciences or Engineering.2+ years' experience in cGMP production of biologics, preferably cell therapy.Significant knowledge in biologics manufacturing, cell culture, and/or cell therapy production.Excellent documentation skills, including adhering to cGMP manufacturing documentation standards.Work Environment
The role requires hands-on work setting up and operating complex equipment in a cleanroom environment. Safety, environmental, and health concerns demand constant attention and strict adherence to company policies, rules, and regulations. Employees will handle biological materials in the cleanroom and must wear appropriate personal protective equipment, including eye protection, mask, coverall gown, gloves, and shoe covers. The position requires extended periods of standing in a cleanroom, up to 3-6 hours at a time, the ability to lift 30 lbs., and occasional weekend and holiday work. The shift is Wednesday to Sunday from 8:30 am to 5 pm.
Job Type & Location
This is a Contract position based out of Frederick, Maryland.
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 31, 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.