New Jersey - Eastern Pennsylvania - Delaware HERC

Position Summary:

• Processes clinical samples received by GMP/PD Facility for clinical testing.
• Processes clinical samples received for manufacturing of the Investigational New Drug (IND) products for clinical trials and Single Patient Use (SPUs).
• Separates cell subsets for therapeutic use.
• Cultures cell populations for therapeutic use.
• Tests the cell products for QC and validation purposes.
• Real-time data entries into the Electronic Manufacturing Database (EMDB) or the corresponding paper forms approved for the procedure by CINJ QAU.
  b. Real-time verification of the data entered into the EMDB by co-workers as assigned by the CMC Manager and GMP/PD Facility SOPs.
• Real-time generation of the Batch Reports.
• Performs non-GMP procedures under supervision or with detailed instructions.
• Processes, separates, cultures, manipulates, and tests cell products, biological samples, and chemical products.
• Conducts in vitro and in vivo studies according to the detailed study plan outlined by the CMC Manager, GMP/PD Facility Director, or PD Manager using existing techniques.

Minimum Education and Experience:

• Bachelor's Degree in the field of medical biosciences, health care, biology, or immunology without any prior relevant work experience or Bachelor's Degree in any field with a minimum of one year of experience in the field of at least one of the following: health care, biological research, clinical laboratory, immunology, or similar.
• Two years or more of experience in GMP Facility and GMP training plus a high school diploma may be substituted for the education requirements.

City: New Brunswick

State: NJ

Physical Demands and Work Environment:

Special Conditions:

• Internal gowning certification within 3 months post recruitment.
• Internal certification for sterile technique within (4) four months post recruitment.
• Yearly vision check followed by correction prescribed by the professional for clear vision.
• Ability to work full time in sterile environment (in clean GMP suites).
• Shared Responsibility for responding to after-hours emergencies in cell processing and equipment monitoring on rotation schedule.
• Flexible work schedule may be required.

Posting Number: 23ST0299

About Rutgers University

Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.

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