Cell Therapy Specialist
Actalent
Frederick, MD (In Person)
$77,220 Salary, Full-Time
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Job Description
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.
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