Rocket is seeking an Associate Director / Director of Viral Vector Therapeutics, who will proactively implement and continue to develop internal viral vector production and associated analytics coordinating with key internal and external stakeholders to advance our transformative cell- and genebased therapies for life-threatening disorders. The primary responsibility of this position is to implement existing viral vector production platforms to seamlessly provide vector material for ongoing clinical trials while developing and implementing improved process developments. The ideal applicant will have a strong background in lentivirus vector (LV) and AAV vector production and associated analytics. The position will support platform-focused drug substance/product projects requiring technology development and platform optimization. The successful candidate will focus on developing and implementing processes related to the production of high quality viral vectors for use in non-clinical and clinical applications.
Viral Vector Therapeutics Duties and Responsibilities
• Oversight of all company related CMO GMP viral vector manufacturing and analytic testing, focusing on reproducibility and compliance
• Review of executed BRs and other production related documents
• Provide scientific expertise and guidance in supporting the analytical and viral vector production needs across the organization
• Advise/consult with CMC team on technology transfer to/from CMOs and CTOs for GMP production and analytic testing
• Identify process development areas for improved efficiencies, yields, and/or cost of goods
• Plan, prepare, execute, and supervise hands-on activities following detailed protocols and SOPs, to complete process development runs in an efficient and safe manner
• Evaluate the results from process development studies to determine the appropriateness and timeline for GMP implementation
Viral Vector Therapeutics Requirements and Qualifications
• PhD in biological sciences with 2+ years of experience (preferably industry)
• Master’s Degree with 5+ years of industry experience
• Extensive experience producing non-GMP and GMP lentivirus vector (LV) and AAV
• Experience with upstream and downstream development for multiple vector production platforms, transient transfection (LV and AAV), packing and producing lines (LV and AAV), and baculovirus-based methods (AAV)
• Experience with upstream and downstream scaling from process development levels (~1 liter) to GMP levels (>1,000 liters)
• Understanding and proficiency with a broad spectrum of viral vector analytical techniques
• Experience managing CMO/CTO relationships and projects
• Organized, detail-oriented, and a self-starter who continuously seeks to improve existing production methods and processes
• Working knowledge of US and European biological drug product development phases with regulatory requirements
• Excellent written and verbal communication skills, analytic and problem-solving capabilities are essential
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to email@example.com