The Clinical Vector Core (CVC) is a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) at the Children’s Hospital of Philadelphia is seeking a Senior GMP Manufacturing Tech. The CCMT fosters a multidisciplinary approach to develop cures for debilitating and life-threatening genetic disorders using innovative gene and cell therapy approaches.
CVC operations include manufacturing, quality control testing, and certification of recombinant adeno-associated and lentiviral viral vectors for use as Investigational Drugs in pre-clinical and early-phase clinical studies. CVC operations comply with FDA’s current Good Manufacturing Practice regulations and other regulatory standards and guidelines applicable to early-phase Investigational Drugs. Vectors are made available to clinical programs in academia, industry and government in the U.S. and abroad.
This role plays a vital role in the day-to-day operations of the Clinical Vector Core to assure the highest achievable quality and consistency of products, adherence to standards established in the CVC, and compliance with cGMP regulations. Manufacturing involves aseptic processing in a pharmaceutical cleanroom facility, large-scale cell culture, viral vector generation, purification, concentration, and fill & finish operations, according to established standard operating procedures (SOPs) and specifications. The position requires good documentation practices, aseptic processing, team work, and an ability to consistently perform delicate tasks according to established procedures in a manufacturing environment. The position requires the employee to consistently exercise discretion and judgment in execution of experiments and of data derived.
All employees are responsible for compliance with written policies and procedures and for correctness, truthfulness, timeliness, legibility, integrity, and accuracy when recording data and observations in compliance with current cGMP regulations.
- General lab duties
- Under supervision, performs tasks per manufacturing records commensurate with training and experience
- Initiates change requests, incident reports and planned deviations
- Performs other duties as assigned
Required Education: High School Diploma/GED
- One (1) year of related experience in cGMP/GLP (or other regulated) environment.