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Job description
Clinical Vector Core Manufacturing SpecialistChildren'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 OverviewThe 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. 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.What You Will DoPerforms tasks per manufacturing records commensurate with training and experienceGeneral advanced lab dutiesReviews SOPs and manufacturing recordsInitiates change requests, incident reports and planned deviationsTrains personnel with less experience commensurate with training and experiencePerforms other duties as assignedEducation QualificationsHigh School Diploma / GED RequiredBachelor's Degree PreferredExperience QualificationsAt least three (3) years of related experience in cGMP/GLP (or other regulated) environment RequiredAt least five (5) years of related experience in cGMP/GLP (or other regulated) environment PreferredSkills and AbilitiesStrong verbal and written communications skillsStrong time management skillsStrong organizational skillsSolid process improvement skillsSolid critical thinking / problem-solving skillsAbility to work independently with minimal supervisionAbility to collaborate with stakeholders at all levelsAbility to gather, analyze and make recommendations/decisions based on data / best practicesAbility to convey complex or technical information in an easy-to-understand mannerAbility to be flexible and adaptable to changeTo 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.Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. 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.
Worksite address
philadelphia, PA, 19104, US
Who can apply
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