Cell Therapy Specialist

Job Title:

Cell Therapy Specialist Job Description The Cell Therapy Specialist plays a key role in the GMP manufacturing of cutting-edge cell therapy products for clinical use. You will execute manufacturing batch records and standard operating procedures, support technology transfer activities, and ensure strict compliance with cGMP and good documentation practices. This position directly supports the production of complex, modern cell therapies that aim to deliver safer and more effective treatment options for patients with autoimmune diseases. Responsibilities Execute manufacturing batch records and standard operating procedures (SOPs) for the production of clinical cell therapy material in a GMP environment. Understand and operate manufacturing equipment and processes used for clinical material production, including complex biologics and cell therapy workflows. Provide expert consultation on technology transfer activities to the MSAT department, ensuring smooth transfer and implementation of manufacturing processes. Assess, troubleshoot, and resolve common problems that arise during cell therapy product manufacturing, escalating issues as appropriate. Comply with cGMP standards at all times and support internal site audits by providing accurate documentation and process information. Undergo advanced training in SOPs and use this expertise to train other team members in proper manufacturing procedures and documentation practices. Author and revise SOPs related to cell therapy manufacturing to ensure procedures remain current, clear, and compliant. Document deviations and corrective and preventive actions (CAPAs), investigate root causes, and propose and implement process improvements. Maintain accurate, complete, and timely batch records and other cGMP documentation in accordance with good documentation practices (GDP). Ensure all manufacturing supplies and materials are replenished, properly labeled, and prepared for cleanroom use. Assist in maintaining a steady supply of materials by identifying and evaluating alternative products and suppliers when needed. Set up, operate, and clean complex manufacturing equipment in a cleanroom environment according to established procedures. Handle biological materials safely and in compliance with all safety, environmental, and health guidelines. Adhere to all company policies, rules, and regulations, including strict compliance with safety procedures and use of required personal protective equipment. Support weekend and occasional holiday manufacturing activities as required to meet production timelines. Essential Skills Hands-on experience in cleanroom operations, including working under aseptic conditions for extended periods. Proficiency in batch record execution, review, and management within a cGMP manufacturing environment. Experience in cell culture and aseptic processing techniques relevant to biologics and cell therapy production. Direct experience with GMP production of biologics, preferably including cell therapy products. Strong knowledge of biologics and cell therapy manufacturing processes, including upstream and/or downstream operations. Familiarity with cGMP regulations and good documentation practices (GDP) for clinical manufacturing. Demonstrated ability to document deviations and CAPAs and support investigations and process improvements. Sterile gowning and aseptic processing qualifications from previous positions, with the ability to consistently maintain sterility. Excellent documentation skills, including following, completing, and reviewing cGMP manufacturing documentation with high accuracy and attention to detail. Ability to apply critical thinking, independent decision-making, and troubleshooting skills to complex manufacturing and cell culture issues. Additional Skills & Qualifications Bachelor's degree in Life Sciences or Engineering, or at least 2+ years of experience in cGMP production of biologics, preferably with cell therapy experience. 2+ years' experience in cGMP production of biologics with significant exposure to cell culture and/or cell therapy manufacturing processes. Significant knowledge of biologics manufacturing, including cell culture operations and cell therapy production workflows. Proven ability to follow and complete detailed documentation associated with cGMP manufacturing activities. High attention to detail and a strong commitment to quality, safety, and compliance. Strong problem-solving skills with the ability to troubleshoot complex biologics manufacturing and cell culture issues. Comfort working with advanced, cutting-edge technologies, including RNA-based and other modern cell therapy platforms. Ability to collaborate effectively with MSAT and cross-functional teams during technology transfer and process optimization initiatives. Work Environment This role is primarily based in a hands-on cleanroom manufacturing environment, where you will set up and operate complex equipment and handle biological materials. The position requires strict adherence to safety, environmental, and health standards, as well as compliance with all company policies, rules, and regulations. You will wear appropriate personal protective equipment, including eye protection, mask, coverall gown, gloves, and shoe covers, while working in the cleanroom. The role involves extended periods of standing, typically 3-6 hours at a time, and the ability to lift up to 30 pounds. Work hours follow a regular shift from Wednesday through Sunday, 8:30 am to 5:00 pm, with occasional weekend and holiday work as needed and additional weekend work about once a month on a volunteer basis. The environment supports complex manufacturing of modern, cutting-edge cell therapy products, including pioneering RNA cell therapies, offering the opportunity to contribute to Phase 3 clinical programs and a mission focused on delivering safer, transformative therapies for patients with autoimmune diseases. Job Type & Location This is a Contract position based out of Frederick, MD. 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 May 5, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.