What are the responsibilities and job description for the Lead GMP specialist - IMCPL position at The University of Pittsburgh?
Lead GMP specialist - IMCPL
The Lead GMP Specialist, executes daily operations within a Cell and Gene Therapy GMP facility. This position involves working with advanced CGT manufacturing processes, ensuring compliance with Good Manufacturing Practices (cGMP), and delivering high-quality clinical-grade CGT products. The role includes troubleshooting issues, training and mentoring junior staff. Perform aseptic manufacturing of cell and gene therapy products in accordance with SOPs, batch records, and cGMP guidelines. Operate equipment for cell processing, including selection, activation, expansion, formulation, and cryopreservation. Conduct routine maintenance and perform preventive checks on manufacturing equipment. Assist in developing manufacturing schedules and ensure timely completion of production tasks while maintaining high standards of accuracy and quality. Assist with equipment commissioning, qualification testing, and process validation activities with Facility, QC, and QA teams.
Directs day-to-day laboratory operations while ensuring compliance with safety regulations and best practices. Works with, adapts, and installs scientific equipment in research laboratories. Develops moderately complex projects and procedures independently. Manages inventory and equipment and performs budget functions. Collaborates to write grant applications and manuscripts.
The Lead GMP Specialist, executes daily operations within a Cell and Gene Therapy GMP facility. This position involves working with advanced CGT manufacturing processes, ensuring compliance with Good Manufacturing Practices (cGMP), and delivering high-quality clinical-grade CGT products. The role includes troubleshooting issues, training and mentoring junior staff. Perform aseptic manufacturing of cell and gene therapy products in accordance with SOPs, batch records, and cGMP guidelines. Operate equipment for cell processing, including selection, activation, expansion, formulation, and cryopreservation. Conduct routine maintenance and perform preventive checks on manufacturing equipment. Assist in developing manufacturing schedules and ensure timely completion of production tasks while maintaining high standards of accuracy and quality. Assist with equipment commissioning, qualification testing, and process validation activities with Facility, QC, and QA teams.
Sitting and standing for long periods. Reading small print, bending and lifting up to 30 pounds and putting away lab supplies. Walking between buildings and labs. Walking to and meetings and or seminars. Walking up and down steps when necessary.
The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.
