GMP Manufacturing Associate

Children's Hospital of Philadelphia • Philadelphia, PA

6d • $58,300 - $72,900

About The Position

The GMP Manufacturing Associate supports day-to-day operations of the Clinical Vector Core (CVC), a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics at Children’s Hospital of Philadelphia. The CVC manufactures, tests, and certifies recombinant adeno-associated and lentiviral vectors for use as investigational drugs in pre-clinical and early-phase clinical studies. Operations follow FDA current Good Manufacturing Practice regulations and other applicable regulatory standards and guidelines.

The role contributes to product quality and consistency, adherence to CVC standards, and cGMP compliance. Manufacturing work includes aseptic processing in a pharmaceutical cleanroom, large-scale cell culture, viral vector generation, purification, concentration, and fill-and-finish operations, following established SOPs and specifications. The associate works independently and may assist with planning and coordination, reviewing records, drafting documents, and training or supervising less experienced personnel, commensurate with training and experience. The position requires good documentation practices, teamwork, and consistent performance of delicate tasks according to established procedures. Employees are responsible for following written policies and procedures and ensuring that recorded data and observations are correct, truthful, timely, legible, complete, and accurate in compliance with current cGMP regulations.

Requirements

• High school diploma or GED required.
• At least three years of related experience in a cGMP/GLP or other regulated environment required.
• Strong verbal and written communication skills.
• Strong time management skills.
• Strong organizational skills.
• Solid process improvement skills.
• Solid critical-thinking and problem-solving skills.
• Ability to work independently with minimal supervision.
• Ability to collaborate with stakeholders at all levels.
• Ability to gather and analyze data and make recommendations or decisions based on data and best practices.
• Ability to convey complex or technical information in an easy-to-understand manner.
• Ability to be flexible and adaptable to change.
• Ability to consistently perform delicate tasks according to established procedures in a manufacturing environment.

Nice To Haves

• Bachelor’s degree preferred.
• At least five years of related experience in a cGMP/GLP or other regulated environment preferred.

Responsibilities

• Performs tasks according to manufacturing records, commensurate with training and experience.
• Performs general advanced laboratory duties.
• Reviews SOPs and manufacturing records.
• Initiates change requests, incident reports, and planned deviations.
• Trains personnel with less experience, commensurate with training and experience.
• May participate in planning and coordination, record review, document drafting, and supervision of junior personnel, commensurate with experience.
• Performs other duties as assigned.
• Complies with written policies and procedures and records data and observations accurately and in accordance with cGMP regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED