Cell Therapy Specialist

The Cell Therapy Specialist plays a key role in the GMP manufacturing of cutting-edge cell therapy and biologic products for clinical use. In this position, you execute manufacturing batch records and standard operating procedures, support technology transfer activities, and help ensure that all production operations comply with cGMP and good documentation practices. You contribute directly to the development and production of advanced RNA and cell therapies that aim to provide safer, 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 and biologic material in a GMP environment.
• Provide expert consultation and hands-on support for technology transfer activities to the MSAT (Manufacturing Science and Technology) team.
• Develop a deep understanding of the manufacturing processes and equipment used for clinical material production, including cell culture and aseptic operations.
• Assess, troubleshoot, and resolve common problems that arise during cell therapy product manufacturing, escalating issues as appropriate.
• Ensure full compliance with cGMP standards and good documentation practices (GDP), and support internal site audits as needed.
• Complete advanced training on relevant SOPs and subsequently train other team members on proper execution and compliance.
• Author, review, and revise SOPs related to cell therapy and biologics manufacturing to maintain accurate and current procedures.
• Document deviations and corrective and preventive actions (CAPAs), investigate root causes, resolve issues, and propose process improvements.
• Maintain accurate and complete batch records, logs, and associated manufacturing documentation in accordance with cGMP requirements.
• Ensure all manufacturing supplies and materials are replenished, properly staged, and prepared for cleanroom use.
• Assist in maintaining a steady supply of raw materials and consumables by identifying and evaluating alternative products and suppliers when necessary.
• Set up, operate, and monitor complex manufacturing equipment used in cell culture, aseptic processing, and biologics production.
• Handle biological materials safely within a cleanroom environment, following all safety, environmental, and health guidelines.
• Adhere strictly to company policies, procedures, and regulations related to safety, quality, and GMP compliance.
• Work the assigned shift schedule and support occasional weekend and holiday production activities as required.

• Hands-on experience in cleanroom operations, including working in controlled environments and following aseptic techniques.
• Proficiency in executing and managing manufacturing batch records and associated cGMP documentation.
• Practical experience in cell culture techniques, including handling suspension cells and small-scale cultures.
• Demonstrated experience in aseptic processing and GMP production of biologics and/or cell therapy products.
• Knowledge of biologics manufacturing processes, cell therapy production, and good documentation practices (GDP).
• Ability to follow, understand, and adhere to cGMP manufacturing documentation and SOPs with high attention to detail.
• Strong troubleshooting skills with the ability to assess and resolve issues in biologics manufacturing and cell therapy production.
• Capability to document deviations and CAPAs, support investigations, and contribute to continuous process improvement.
• Competence in sterile gowning procedures and maintaining aseptic qualifications in a cleanroom environment.

• Bachelor’s degree in Life Sciences or Engineering, or equivalent combination of education and experience.
• At least 2 years of experience in cGMP production of biologics, preferably with direct cell therapy manufacturing experience.
• Significant knowledge of biologics manufacturing processes, cell culture operations, and/or cell therapy production workflows.
• Excellent documentation skills, including accurately following, completing, and reviewing cGMP manufacturing records and logs.
• Strong critical thinking skills with the ability to apply independent decision-making to complex manufacturing and cell culture issues.
• High attention to detail and a methodical approach to work in a regulated manufacturing environment.
• Demonstrated ability to troubleshoot complex issues in biologics manufacturing, cell culture, and cell therapy production.
• Proven sterile gowning and aseptic processing qualifications from previous roles in GMP or cleanroom settings.
• Ability to collaborate effectively with cross-functional teams, including MSAT and quality functions, in a fast-paced environment.
• Motivation to contribute to innovative therapies, including RNA and cell-based treatments for autoimmune diseases.

This position is fully hands-on in a cleanroom manufacturing environment, with a strong emphasis on safety, environmental stewardship, and health considerations. You will regularly set up and operate complex equipment for cell culture, aseptic processing, and biologics production while handling biological materials under strict GMP conditions. The role requires strict adherence to company policies, rules, and regulations, including the consistent use of appropriate personal protective equipment such as eye protection, mask, coverall gown, gloves, and shoe covers. You will spend extended periods standing in the cleanroom, typically 3 to 6 hours at a time, and must be able to lift up to 30 pounds as part of routine operations. The core shift runs from 8:30 am to 5:00 pm, generally Monday through Friday or Wednesday through Sunday depending on assignment, with occasional weekend and holiday work required and some weekend work typically available on a volunteer basis about once per month. The environment is collaborative and mission-driven, focused on the complex manufacturing of modern, cutting-edge cell therapy products and pioneering RNA cell therapies for patients with autoimmune diseases.

Job Type & Location

This is a Contract position based out of Frederick, MD.

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)

This is a fully onsite position in Frederick,MD.

This position is anticipated to close on May 18, 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.