Job Title: Manufacturing Associate - Cell Therapy (GMP)Job Description
The Manufacturing Associate supports the production of cutting-edge cell therapy clinical materials in a highly regulated GMP environment. This role executes manufacturing batch records and standard operating procedures, contributes to technology transfer activities, and helps optimize complex biologics and cell therapy processes. The position is ideal for someone who enjoys hands-on work in a cleanroom, takes pride in meticulous documentation, and wants to contribute to advancing next-generation RNA cell therapies 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 as part of a collaborative team.
Provide expert input and consultation on technology transfer activities to support manufacturing sciences and technology (MSAT) initiatives.
Maintain a detailed understanding of the end-to-end manufacturing process and the operation of equipment used for the production of clinical material.
Assess, troubleshoot, and resolve common problems that arise during cell therapy product manufacturing, escalating issues appropriately when needed.
Comply with cGMP standards, good documentation practices (GDP), and company procedures while completing and reviewing executed manufacturing documentation in a timely manner.
Support internal site audits and compliance activities by providing accurate documentation and process knowledge.
Undergo advanced training in required SOPs and work instructions for cell therapy manufacturing and serve as a trainer for other team members when necessary.
Author, review, and revise SOPs and related documentation for cell therapy manufacturing to ensure processes remain current and compliant.
Document deviations and corrective and preventive actions (CAPAs), investigate and resolve issues, identify root causes, and propose process improvements.
Communicate findings, investigations, and proposed process improvements clearly to senior leadership and cross-functional stakeholders.
Ensure manufacturing supplies are replenished and prepared for use in the cleanroom, maintaining readiness for ongoing production activities.
Assist in maintaining a steady supply of materials by actively identifying and evaluating alternative products and suppliers in coordination with management.
Follow aseptic techniques and sterile gowning procedures to maintain cleanroom integrity and product quality.
Adhere strictly to safety, environmental, and health regulations while handling biological materials and operating complex equipment.
Work the assigned Wednesday-Sunday shift from 8:30 a.m. to 5:00 p.m., including occasional weekend and holiday work as required by production schedules.
Essential Skills
Minimum of 2 years of experience in cGMP production of biologics, with cell therapy manufacturing experience strongly preferred.
Proven experience working in a GMP production environment, including cleanroom operations and batch record execution.
Hands-on experience with cell culture processes and techniques in a biologics or cell therapy setting.
Demonstrated proficiency in aseptic techniques and aseptic processing within a cleanroom environment.
Significant knowledge of biologics manufacturing processes, cell culture, and/or cell therapy production workflows.
Strong documentation skills, including accurately following, completing, and reviewing documentation associated with cGMP manufacturing and GDP.
Ability to apply critical thinking and independent decision-making to complex biologics manufacturing, cell culture, and cell therapy production issues.
Demonstrated troubleshooting skills for resolving technical and process-related issues in a GMP manufacturing setting.
Sterile gowning qualifications and experience maintaining strict aseptic conditions in previous roles.
Ability to stand for extended periods (3-6 hours at a time) and lift up to 30 pounds while performing cleanroom duties.
Availability to work a Wednesday-Sunday schedule from 8:30 a.m. to 5:00 p.m., with flexibility for occasional weekend and holiday work.
Additional Skills & Qualifications
Bachelor's degree (BS) in Life Sciences or Engineering or a closely related discipline.
Experience in cell therapy or biologics manufacturing in a Phase 3 clinical or late-stage development environment is beneficial.
Familiarity with documenting and managing deviations and CAPAs in a regulated environment.
Comfort working with complex manufacturing equipment and automated systems in a cleanroom setting.
Strong attention to detail and a high level of accuracy in both technical work and documentation.
Effective communication skills to clearly convey findings, issues, and process improvements to leadership and cross-functional teams.
Motivation to work on innovative RNA cell therapy platforms and contribute to developing safer, more potent therapies for autoimmune diseases.
Ability to work effectively in a team-oriented, fast-paced, and highly regulated environment while maintaining a continuous improvement mindset.
Work Environment
This role is based in a highly controlled GMP cleanroom environment focused on complex, modern cell therapy manufacturing. The position requires hands-on work setting up and operating complex equipment and handling biological materials under strict aseptic conditions. Team members must maintain constant awareness of safety, environmental, and health requirements and follow all company policies, rules, and regulations. The work involves extended periods of standing in the cleanroom (3-6 hours at a time) and lifting up to 30 pounds. Appropriate personal protective equipment is required at all times, including eye protection, mask, coverall gown, gloves, and shoe covers. The standard shift runs Wednesday through Sunday from 8:30 a.m. to 5:00 p.m., with occasional weekend and holiday work based on production needs. The environment is mission-driven and centered on reimagining cell therapies with transformative technologies, offering the opportunity to contribute directly to pioneering RNA cell 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 Apr 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.
