Gene Therapy Experts

Gene Therapy Experts: Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking accomplished, Senior-Level Gene Therapy Regulatory and Compliance experts to add to its team of full time and per diem consultant professionals. The professional must have a strong background and demonstrable hands-on experience and skills. • High-level biotechnology / biopharmaceutical / gene therapy experience • Genetic construct design review expertise • Adeno-associated virus (AAV) capsid / vector engineering, manufacturing, and optimization • Quality Operations / Quality Systems – implementation of QA and QC systems and processes for gene therapy products including testing and release of products; regulatory requirements pertaining to biologics • Aseptic biologic manufacturing • Viral and non-viral control delivery strategies and therapies • Viral vector biology and therapeutic vector delivery • Filing requirements for gene therapy products • Knowledge of FDA, EU and International regulations, EU, and US and industry best practices regarding documentation systems, design control, change control, product specifications and applicable GxPs • Gene therapy safety and risk assessments • Deep knowledge of molecular biology Educational / Experience Requirements include: • M.S. (Ph.D. Preferred) in immunology or molecular biology, virology, bioengineering or related field • 10+ years of experience in the biotechnology industry Apply to: For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective, and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable, and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology. Apply tot his job