Rocket is seeking an Associate Director / Director of Gene-Modified Cell Therapeutics, who will oversee CMO GMP manufacturing and associated analytics of gene-modified hematopoietic cells while 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 assure proper and controlled gene-modified cell therapy manufacturing at CMOs while identifying, testing, and implementing process improvements. The ideal applicant will have a strong background in hematopoietic stem cell biology and GMP manufacturing. The position will support platform-focused drug product projects requiring technology development and platform optimization. The successful candidate will focus on reproducibility and compliance of manufacturing at CMOs while developing and implementing processes related improvements for the production of high quality cell-based therapies.
Gene-Modified Cell Therapeutics Duties and Responsibilities
• Oversight of all company related GMP gene-modified cell therapy 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 cell therapy manufacturing needs across the organization
• Identify process development areas for improved efficiencies, yields, and/or cost of goods
• Develop and lead studies on hematopoietic cell isolation, media development, enhanced genetic modification, cell expansion, formulation/fill, and cryopreservation
• 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
Gene-Modified Cell Therapeutics Requirements and Qualifications
• PhD in biological sciences with 2+ years of experience (preferably industry)
• Master’s Degree with 5+ years of cell process development and manufacturing experience
• Experience in GMP manufacturing of gene-modified hematopoietic cell therapies and working with external CMOs and CTOs
• Understanding and proficiency with a broad spectrum of gene-modified hematopoietic cell therapies analytical techniques
• Organized, detail-oriented, and a self-starter who continuously seeks to improve existing production methods and processes
• Working knowledge of US and European cell-based 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?
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