Cell Therapy Specialist
Talentify, Frederick, MD, United States
Job Title: Cell Therapy Specialist
Job Description
We are seeking a dedicated and skilled Cell Therapy Specialist to join our team in a GMP environment. This role involves executing manufacturing batch records and standard operating procedures for the production of clinical material. You will also provide expert consultation on tech transfer activities, ensuring compliance with cGMP standards and good documentation practices. Responsibilities
Execute manufacturing batch records and SOPs for production of clinical material. Provide expert consultation on tech transfer activities to the MSAT department. Understand the manufacturing process and equipment for clinical material production. Assess and resolve common problems during cell therapy product manufacturing. Comply with cGMP standards and support internal site audits. Undergo advanced training in SOPs and train others as necessary. Author and revise SOPs for cell therapy manufacturing. Document Deviations and CAPAs, investigate and resolve problems, and propose process improvements. Ensure all manufacturing supplies are replenished and prepared for clean room use. Assist management in ensuring a steady supply of materials by searching for alternative products and suppliers. Essential Skills
Proficiency in cleanroom operations, batch record management, and manufacturing processes. Experience in cell culture, aseptic processing, and GMP production. Knowledge of biologics, cell therapy, and good documentation practices (GDP). Additional Skills & Qualifications
BS Degree in Life Sciences or Engineering. 2+ years of experience in cGMP production of biologics, preferably cell therapy. Strong documentation skills and the ability to follow cGMP manufacturing documentation. Critical thinking, independent decision-making, and troubleshooting skills. Sterile gowning and aseptic processing qualifications. Work Environment
The position involves hands‑on work in a cleanroom environment, requiring constant attention to safety, environmental, and health concerns. The role demands adherence to company policies, including wearing personal protective equipment such as eye protection, mask, gown, gloves, and shoe covers. The position involves extended periods of standing (3–6 hours) and lifting up to 30 lb. Occasional weekend and holiday work is required. The regular shift is Wednesday through Sunday, 8:30 am to 5:00 pm, with possible weekend work once a month 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 4, 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.
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Job Description
We are seeking a dedicated and skilled Cell Therapy Specialist to join our team in a GMP environment. This role involves executing manufacturing batch records and standard operating procedures for the production of clinical material. You will also provide expert consultation on tech transfer activities, ensuring compliance with cGMP standards and good documentation practices. Responsibilities
Execute manufacturing batch records and SOPs for production of clinical material. Provide expert consultation on tech transfer activities to the MSAT department. Understand the manufacturing process and equipment for clinical material production. Assess and resolve common problems during cell therapy product manufacturing. Comply with cGMP standards and support internal site audits. Undergo advanced training in SOPs and train others as necessary. Author and revise SOPs for cell therapy manufacturing. Document Deviations and CAPAs, investigate and resolve problems, and propose process improvements. Ensure all manufacturing supplies are replenished and prepared for clean room use. Assist management in ensuring a steady supply of materials by searching for alternative products and suppliers. Essential Skills
Proficiency in cleanroom operations, batch record management, and manufacturing processes. Experience in cell culture, aseptic processing, and GMP production. Knowledge of biologics, cell therapy, and good documentation practices (GDP). Additional Skills & Qualifications
BS Degree in Life Sciences or Engineering. 2+ years of experience in cGMP production of biologics, preferably cell therapy. Strong documentation skills and the ability to follow cGMP manufacturing documentation. Critical thinking, independent decision-making, and troubleshooting skills. Sterile gowning and aseptic processing qualifications. Work Environment
The position involves hands‑on work in a cleanroom environment, requiring constant attention to safety, environmental, and health concerns. The role demands adherence to company policies, including wearing personal protective equipment such as eye protection, mask, gown, gloves, and shoe covers. The position involves extended periods of standing (3–6 hours) and lifting up to 30 lb. Occasional weekend and holiday work is required. The regular shift is Wednesday through Sunday, 8:30 am to 5:00 pm, with possible weekend work once a month 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 4, 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.
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