Director Process Development

Work Location: Durham County, North Carolina

Summary:

Lead technical development and manufacturing activities for gene therapy programs, focusing on process development, technical transfer, and execution to support product development and manufacturing goals. Collaborate with external partners to design studies, analyze data, and ensure regulatory compliance for gene therapy assets.

Responsibilities:

• Oversee the development and execution of robust manufacturing programs for gene therapy assets, ensuring support for preclinical, clinical, and commercial supply needs.
• Prepare, review, and approve technical and regulatory documentation, including manufacturing plans, batch records, product specifications, and stability programs.
• Manage the creation and approval of manufacturing and testing documentation, such as certificates of analysis, campaign summary reports, and investigations.
• Lead the preparation and review of regulatory submissions, including pINDs, INDs, agency responses, meeting requests, briefing packages, and BLAs.
• Ensure the availability and release of reference standard materials and lead technology transfer activities between manufacturing sites.
• Maintain compliance with regulatory requirements for manufacturing campaigns, including Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents.
• Act as the CMC expert during audits and regulatory interactions, and serve as the on-site representative at partner manufacturing facilities as needed.
• Direct project management activities for multiple gene therapy programs across various development stages, resolving operational challenges and escalating issues as necessary.

Qualifications:

• Master’s degree (minimum) in a science or health-related field from an accredited institution.
• 7-10 years of experience in the pharmaceutical or biotechnology industry; ophthalmology experience preferred.
• At least 5 years of direct manufacturing experience for biopharmaceuticals; preference for AAV gene therapy and CDMO/contract lab experience.
• Proven experience in technical transfer, scale-up campaigns, and associated documentation.
• Experience preparing and reviewing regulatory submissions (pINDs, INDs, Meeting Requests, Briefing Packages, Annual Reports/DSURs, BLAs).
• Familiarity with FDA and other regulatory agency requirements and interactions.
• Strong ability to work with multidisciplinary teams and a clear understanding of the drug development process across multiple phases.
• Experience with Orphan/Rare Disease programs and/or Fast Track/Breakthrough Therapy is a plus.
• Demonstrated leadership, negotiation, risk assessment, and problem-solving skills; ability to influence cross-functional teams without direct authority.
• Excellent interpersonal, oral, and written communication skills; strong time management and multitasking abilities.
• Advanced proficiency in computer software (Word, Excel, Smartsheet, PowerPoint, etc.).
• Ability to travel up to 20% of the time and work in laboratory settings.
• Ability to sit for prolonged periods and lift up to 15 pounds as needed.

Published Category: Manufacturing & Technical Operations, Supply Chain & CMC