Summary

The position involves producing large-scale therapeutic products in a Good Manufacturing Practices (GMP) facility for clinical studies. In addition to having adequate training and experience, the candidate must be willing to become familiar with and comply with GMP guidelines to ensure products are consistently produced and controlled according to quality standards. Working in the GMP facility requires wearing appropriate attire and following gowning procedures, as well as adhering to Standard and Universal Precautions when handling blood, blood products, and any potentially infectious materials.

Job Duties

• Perform routine cell biology and molecular biology studies. Defines problems and possible solutions.
• Plans, directs and conducts research experiments. Evaluates and analyzes data. Prepares reports.
• Trains and orients less experienced staff.
• Maintenance of equipment and documentation.
• Produce large-scale clinical grade Viral Vectors, plasmid DNA and Cell banks in a Good Manufacturing Practices (GMP) facility.
• Be familiar or willingness to become familiar and to comply with Good Manufacturing Practices for therapeutic agents.
• Establish, perform and interpret tests and experiments designated to determine the safety and identity of the therapeutic agents for clinical trials.
• Independently troubleshoot experiments and assist with the development and implementation of new procedures/processes.
• Assist in creating standard operating procedures for GMP productions.
• Assist in training less experienced staff.
• Responsible for maintaining equipment and documentation to ensure compliance with appropriate regulations.
• Performs other job related duties as assigned.

Minimum Qualifications

• Master\'s degree in Basic Science or a related field.  Experience in lieu of degree will not be accepted.
• Three years of relevant experience typically as a Research Assistant, Research Technician or Postdoctoral Fellow/Associate.

Preferred Qualifications

• Five years of Tissue culture experience and experience with viral vector production is highly preferred.
• Requires experience in cell culture with excellent aseptic technique, as well as proficiency in other areas of cell biology and molecular biology, including DNA, RNA, and protein extraction, purification, and analysis.
• Precision in preparing materials and recording data.
• Assist to train and supervise less experienced staff.
• Takes routine or necessary actions to address customer needs, responding promptly and accurately to complaints, inquiries, and requests for information, and coordinating appropriate follow-up.