Job Description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Position: Cell Therapy Specialist I

Location: Frederick, MD

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: 6:00 am to 4:30 pm (Day Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
3:00 pm to 1:30 am (Swing Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
5:00 pm to 3:30 am (Swing Shift), Sun-Wed, Wed-Sat, and Thurs-Sun

Job Description:

• Everyone at this facility is grounded by one common goal curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
• Would you like to join us in this mission?
• We are seeking a highly motivated, Cell Therapy Specialist to join our newly formed Cell Therapy Manufacturing team at our brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland.
• The Cell Therapy Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.

Responsibilities (include but are not limited to):

• To be considered for this role, you must meet the following basic criteria:
• Successfully troubleshoots processing and equipment issues while communicating said issues to management
• Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements
• Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements, and supports efficient operations
• Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms. All required PPE and gowning for classified GMP manufacturing areas are provided by the company.
• Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls
• Ability to wear a respirator during use of certain cleaning chemicals

Basic Qualifications:

• Bachelor s Degree in Life Sciences Field
• Associates Degree in Life Sciences Field with 1+ years of biotech experience or
• High School Diploma with 2+ years of cGMP experience

TekWissen Group is an equal opportunity employer supporting workforce diversity.

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