Cell Therapy Specialist
Actalent, Frederick, MD, United States
Job Title: Cell Therapy Specialist
Job Description We are seeking a dedicated Cell Therapy Specialist to join our team, contributing to the production of clinical material in a GMP environment. This role involves executing manufacturing batch records and standard operating procedures, providing expert consultation on tech transfer activities, and ensuring compliance with cGMP standards and good documentation practices. Responsibilities
Execute manufacturing batch records and standard operating procedures for production of clinical material in a GMP environment. Provide expert consultation on tech transfer activities to the MSAT department. Maintain a detailed understanding of the manufacturing process and equipment used for clinical material production. Assess and resolve common problems during cell therapy product manufacturing. Comply with cGMP standards and good documentation practices. Conduct timely reviews of executed manufacturing documentation and support internal site audits for compliance. Undergo advanced training in SOPs and work instructions for cell therapy manufacturing, and train others as needed. Author and revise SOPs for cell therapy manufacturing. Document Deviations and CAPAs, investigate and resolve issues, identify root causes, and propose process improvements. Ensure that all manufacturing supplies are replenished and prepared for use in the cleanroom environment. Assist management in ensuring a steady supply of materials by actively searching for alternative products and suppliers. Essential Skills
Experience in cleanroom and GMP production. Proficiency in cell culture and aseptic processing. Experience with cell therapy or biologics manufacturing. Excellent documentation skills in cGMP manufacturing. Ability to apply critical thinking, independent decision-making, and troubleshooting skills. Additional Skills & Qualifications
Bachelor's Degree in Life Sciences or Engineering. 2+ years of experience in cGMP production of biologics, preferably in cell therapy. Significant knowledge in biologics manufacturing, cell culture, and/or cell therapy production. Sterile gowning and aseptic processing qualifications. Work Environment This position requires hands-on work setting up and operating complex equipment in a cleanroom environment. Employees must adhere to strict safety, environmental, and health regulations. Personal protective equipment, such as eye protection, masks, coverall gowns, gloves, and shoe covers, is mandatory. The role involves extended periods of standing in a cleanroom for up to 3-6 hours, lifting up to 30 lbs, and occasional weekend and holiday work. The standard shift is Monday through Friday, 8:30 am to 5 pm, with potential weekend work about once a month, usually on a volunteer basis. 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 1, 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 .
Job Description We are seeking a dedicated Cell Therapy Specialist to join our team, contributing to the production of clinical material in a GMP environment. This role involves executing manufacturing batch records and standard operating procedures, providing expert consultation on tech transfer activities, and ensuring compliance with cGMP standards and good documentation practices. Responsibilities
Execute manufacturing batch records and standard operating procedures for production of clinical material in a GMP environment. Provide expert consultation on tech transfer activities to the MSAT department. Maintain a detailed understanding of the manufacturing process and equipment used for clinical material production. Assess and resolve common problems during cell therapy product manufacturing. Comply with cGMP standards and good documentation practices. Conduct timely reviews of executed manufacturing documentation and support internal site audits for compliance. Undergo advanced training in SOPs and work instructions for cell therapy manufacturing, and train others as needed. Author and revise SOPs for cell therapy manufacturing. Document Deviations and CAPAs, investigate and resolve issues, identify root causes, and propose process improvements. Ensure that all manufacturing supplies are replenished and prepared for use in the cleanroom environment. Assist management in ensuring a steady supply of materials by actively searching for alternative products and suppliers. Essential Skills
Experience in cleanroom and GMP production. Proficiency in cell culture and aseptic processing. Experience with cell therapy or biologics manufacturing. Excellent documentation skills in cGMP manufacturing. Ability to apply critical thinking, independent decision-making, and troubleshooting skills. Additional Skills & Qualifications
Bachelor's Degree in Life Sciences or Engineering. 2+ years of experience in cGMP production of biologics, preferably in cell therapy. Significant knowledge in biologics manufacturing, cell culture, and/or cell therapy production. Sterile gowning and aseptic processing qualifications. Work Environment This position requires hands-on work setting up and operating complex equipment in a cleanroom environment. Employees must adhere to strict safety, environmental, and health regulations. Personal protective equipment, such as eye protection, masks, coverall gowns, gloves, and shoe covers, is mandatory. The role involves extended periods of standing in a cleanroom for up to 3-6 hours, lifting up to 30 lbs, and occasional weekend and holiday work. The standard shift is Monday through Friday, 8:30 am to 5 pm, with potential weekend work about once a month, usually on a volunteer basis. 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 1, 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 .