GMP Manufacturing Associate
About The Position
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. 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. This role will work independently and self-directed and is involved in personnel training and supervising junior personnel as required. The employee will also participate in and assist with planning and coordination, reviewing of records, drafting of documents, and training and supervision of junior personnel commensurate with experience. 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.
Requirements
- High School Diploma / GED Required
- At least three (3) years of related experience in cGMP/GLP (or other regulated) environment Required
- Strong verbal and written communications skills
- Strong time management skills
- Strong organizational skills
- Solid process improvement skills
- Solid critical thinking / problem-solving skills
- Ability to work independently with minimal supervision
- Ability to collaborate with stakeholders at all levels
- Ability to gather, analyze and make recommendations/decisions based on data / best practices
- Ability to convey complex or technical information in an easy-to-understand manner
- Ability to be flexible and adaptable to change
Nice To Haves
- Bachelor's Degree Preferred
- At least five (5) years of related experience in cGMP/GLP (or other regulated) environment Preferred
Responsibilities
- Performs tasks per manufacturing records commensurate with training and experience
- General advanced lab duties
- Reviews SOPs and manufacturing records
- Initiates change requests, incident reports and planned deviations
- Trains personnel with less experience commensurate with training and experience
- Performs other duties as assigned
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
