Cell & Gene Therapy Associate

Job Description

Job DescriptionJob Title: Cell & Gene Therapy Associate
Job Description

The Cell & Gene Therapy Associate supports clinical manufacturing operations in a clean room environment, focusing on cell processing and cell therapy production. This role assists with clean room qualification, performs aseptic operations, and contributes to the preparation and manipulation of cell products to ensure safe and effective therapies. The position is ideal for someone early in their career who is eager to gain hands-on experience in a fast-paced cellular therapy and GMP manufacturing setting with strong training and growth potential.

Responsibilities

• Assist in clean room qualification activities, including burdening clean rooms for testing according to established procedures.
• Run and stage supplies and materials needed to support clean room operations and processing activities.
• Perform aseptic gowning to enter and work within the clean room environment in compliance with gowning procedures.
• Work within the manufacturing area to help process cells and samples for clinical manufacturing.
• Process cell cultures, cryopreserve, and manipulate cell products using aseptic technique and established protocols.
• Perform any and all processing and testing required to produce and assess safe and efficacious cell-based products.
• Work in a cellular facility and clean room environment while adhering to GMP practices and standard operating procedures (SOPs).
• Support stem cell preparation, cell and tissue culture, including cell expansions, volume reductions, depletions, and enrichments.
• Handle and complete batch records accurately and consistently to document all manufacturing and processing steps.
• Contribute to clinical trial support activities by performing manufacturing tasks related to investigational cell therapies.
• Follow Good Manufacturing Practice (GMP) guidelines and maintain compliance with all quality and safety standards.
• Communicate effectively with team members and operations leadership to coordinate daily tasks and shift priorities.
• Adapt to changing priorities and timelines in a fast-paced clinical manufacturing environment.
• Participate in ongoing training to maintain proficiency in aseptic technique, clean room practices, and cell processing methods.

Essential Skills

• Experience working within a cell-based biology laboratory, either in an academic or industry setting.
• Hands-on experience with aseptic technique in a laboratory or clean room environment.
• Familiarity with Good Manufacturing Practice (GMP) practices and adherence to standard operating procedures (SOPs).
• Ability to perform cell culture, including handling, maintaining, and manipulating cell lines or primary cells.
• Experience working in a fast-paced environment while managing multiple tasks and priorities.
• Ability to work in a clean room environment and follow aseptic gowning procedures.
• Experience with batch records and accurate documentation of laboratory or manufacturing activities.
• Ability to effectively communicate within a team environment, both verbally and in writing.
• Willingness and ability to work flexible shifts, including weekends, and to adjust to changing schedules.
• Capability to follow detailed technical instructions and maintain high attention to detail in all processing and testing activities.

Additional Skills & Qualifications

• Associate’s or Bachelor’s degree in biology or a related scientific field is a plus.
• Bachelor’s degree in a scientific discipline is preferred.
• Previous experience in a cellular facility or clinical manufacturing laboratory.
• Experience with stem cell preparation and cell or tissue culture techniques.
• Background in cell therapy or cell and gene therapy manufacturing environments.
• Exposure to clinical trial support processes related to cell-based products.
• Experience with cell expansions, volume reductions, depletions, and enrichments.
• Previous experience with laboratory gowning and working in controlled environments.
• Demonstrated positive attitude, willingness to learn, and openness to extensive training.
• Interest in building a long-term career in cell and gene therapy or biopharmaceutical manufacturing.

Work Environment

The role is based in clinical manufacturing laboratories and clean room facilities dedicated to cell and gene therapy production. You will work as part of a large team of operators and report into operations leadership within a structured GMP environment. The position involves extensive training, particularly in aseptic gowning and clean room practices, with managers and team members providing hands-on support. During the first 2–3 months, training typically occurs Monday through Friday from 8:00 a.m. to 4:00 p.m. After training, all team members must remain flexible on shift assignments and be open to working weekends, including Saturday and Sunday. You may be scheduled on first or second shift, and at times you may be required to work as late as approximately 2:30 a.m. Shift start times can change, and in some cases you may receive your arrival time the day before your shift. The work environment is fast paced, highly regulated, and focused on maintaining strict cleanliness and aseptic conditions while supporting the manufacture of clinical cell therapy products.

Job Type & Location

This is a Contract to Hire position based out of Allendale, NJ.

Pay and Benefits

The pay range for this position is $29.78 - $29.78/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 Allendale,NJ.

Application Deadline

This position is anticipated to close on May 6, 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.