• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $175,000 - $200,000

Position Summary

The Associate Director, Process Development and cGMP 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 Associate Director of PD and cGMP Operations will report to the 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

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

About Columbia University

Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.

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