Asst Director,Proc Dev/Mfg Ops

Columbia University
United States, New York, New York
Nov 08, 2024
Job Type: Officer of Administration Bargaining Unit: Regular/Temporary: Regular End Date if Temporary: Hours Per Week: 35 Standard Work Schedule: Building: Salary Range: $130,000 - $150,000 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary The Assistant Director, Process Development and Manufacturing Operations, will oversee the development and execution of manufacturing processes for cell and gene therapies. as well as operations in the new cGMP laboratory. This role will ensure the technical advancement of process development and manufacturing operations, compliance with GMP standards, and support both sponsored and investigator-initiated clinical trials. The Assistant Director of PD and Manufacturing Operations will report to Director of the CICET Core Facilities and oversee the management of facilities and equipment as well as the facilities and manufacturing personnel in the laboratory. Responsibilities Manufacturing and Process Development Develop and implement cell production, vector production, and genome editing manufacturing processes. Oversee the scale-up and tech transfer of therapeutic products from development to production. Develop SOPs, batch production control records, and validation protocols aligned with QA. Regulatory Compliance Ensure all manufacturing processes comply with FDA, GMP, FACT, and other regulatory standards. Coordinate with the Clinical Trials Office for CMC, investigator manuals, and IND development and submission. Participate in regulatory audits and inspections of the GMP laboratory, coordinating with the QA Director, sponsors, and appropriate stakeholders. Contribute to regulatory submissions and maintain robust documentation and evaluation metrics for all manufacturing activities. Coordination and Collaboration Coordinate cross-functional teams to meet production timelines, interfacing with QA/QC teams. Collaborate with CICET groups, stakeholders, and vendors to integrate new technologies and processes into manufacturing. Operations and Risk Management Oversee facilities and equipment validation and preventative maintenance. Develop and implement maintenance schedules and validation protocols for facilities and equipment. Conduct risk assessments and implement mitigation strategies for manufacturing operations. Budgeting and Financial Management Develop and manage the budget for the cGMP manufacturing operations. Leadership and Training Provide leadership in training personnel, troubleshooting, and resolving process-related issues. Minimum Qualifications Bachelor's degree in Biotechnology, Bioengineering, or related field, or equivalent in education and experience Minimum of 4 years of experience in cell therapy manufacturing Proven track record of managing GMP-compliant manufacturing operations Strong leadership skills with experience in team management and development Preferred Qualifications Strongly prefer at least 7 years of experience in cell therapy manufacturing Advanced degree (MS or PhD) in a relevant scientific discipline Experience with academic or industry GMP manufacturing Familiarity with automation and single-use technologies in a GMP environment Demonstrated ability to work collaboratively with clinical and regulatory teams Other Requirements Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.