GMP Manufacturing Technician- Materials

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Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.

CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.

A Brief Overview

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.

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This role plays a vital role to support the day-to-day operations of the Clinical Vector Core to ensure 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, team work, and an ability to consistently perform delicate tasks according to established procedures in a manufacturing environment.

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.

What you will do

• General lab duties
• Under supervision, performs tasks per standard operating procedures and/or manufacturing records, commensurate with training and experience
• Initiates change requests, incident reports and planned deviations
• Performs other duties as assigned
• Performs tasks per material control SOPs
• Responsible for staging materials for manufacturing, restocking gowning supplies, preparing labware for use
• Responsible for monitoring the expiration and stocking of materials and cleaning agents in the cleanroom facility, removing expired materials, and replenishing as required
• Responsible for transfer and replenish of material between warehouse locations within the facility

Education Qualifications

• High School Diploma / GED Required
• Associate's Degree Preferred

Experience Qualifications

• Previous related classroom or laboratory experience Required
• At least one (1) year of related experience in cGMP/GLP (or other regulated) environment Preferred
• At least six (6) monthsof related classroom or laboratory experiencePreferred
• At least one (1) year of inventory, materials, or warehouse experience Preferred

Skills and Abilities

• Solid time management skills
• Solid organizational skills
• Solid verbal and written communications skills
• Ability to work independently with minimal supervision
• Ability to collaborate with stakeholders at all levels

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.