GMP Manufacturing Associate

About the role

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.

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, teamwork, and an ability to consistently perform delicate tasks according to established procedures in a manufacturing environment.

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
• Works independently and self-directed, including supervising junior personnel as required
• Participates in and assists with planning and coordination, reviewing of records, and drafting of documents
• Performs other duties as assigned

Requirements

• High School Diploma / GED Required
• Bachelor's Degree Preferred
• At least three (3) years of related experience in cGMP/GLP (or other regulated) environment Required
• At least five (5) years of related experience in cGMP/GLP (or other regulated) environment Preferred

Skills and Abilities

• 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

Pay

Salary range: $58,300.00 - $72,900.00 annually. Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.