Job Title: Cell Therapy SpecialistJob Description We are seeking a Cell Therapy Specialist to join our team. In this role, you will execute manufacturing batch records and standard operating procedures (SOPs) for the production of clinical material in a GMP environment. You will provide expert consultation on tech transfer activities and have a deep understanding of the manufacturing process and the equipment used for production. This position involves resolving common problems during cell therapy product manufacturing, ensuring compliance with cGMP standards, and supporting internal site audits. You will also undergo advanced training and train others in cell therapy manufacturing processes, author and revise SOPs, and document deviations and CAPAs. Responsibilities + Execute manufacturing batch records and SOPs for production of clinical material in a GMP environment. + Provide expert consultation on tech transfer activities. + Understand the manufacturing process and equipment used for production of clinical material. + Assess and resolve common problems during cell therapy product manufacturing. + Comply with cGMP standards and good documentation practices. + Timely review of executed manufacturing documentation. + Support internal site audits per compliance. + Undergo advanced training in required SOPs and work instructions for cell therapy manufacturing. + Train others in cell therapy manufacturing processes. + Author and revise SOPs as necessary for cell therapy manufacturing. + Document deviations and CAPAs, investigate and resolve problems, identify root causes, and propose process improvements. + Ensure that all supplies for manufacturing are replenished and prepared for use in the cleanroom environment. + Assist management with ensuring a steady supply of materials by searching for alternative products and suppliers. Essential Skills + Significant knowledge in the biologics manufacturing process, cell culture, and/or cell therapy production. + Excellent documentation skills, including following and completing documentation associated with cGMP manufacturing. + Critical thinking and independent decision-making skills. + High attention to detail and troubleshooting skills. + Sterile gowning and aseptic processing qualifications. Additional Skills & Qualifications + BS Degree in Life Sciences or Engineering. + 1+ years' experience in cGMP production of biologics, preferably cell therapy experience. Work Environment This position requires hands-on work setting up and operating complex equipment in a cleanroom environment. Safety, environmental, and health concerns demand constant attention. Strict adherence to company policies, rules, and regulations is required. The employee will handle biological materials in the cleanroom environment and will be required to wear appropriate personal protective equipment, including eye protection, mask, coverall gown, gloves, and shoe covers. The position requires extended periods of standing in the cleanroom, up to 3-6 hours at a time, the ability to lift 30 lb., and occasional weekend and holiday work. Pay and Benefits The pay range for this position is $31.25 - $33.65/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 Feb 28, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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 The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.