Cell 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, Cell Therapy Regulatory and Compliance experts to add to its team of full time & per diem consultant professionals. The professional must have a strong background and demonstrable hands-on experience and skills.

• Deep knowledge of cell therapy; CAR T cell therapy and adoptive cell therapy
• Demonstrated understanding of ATMs
• Understanding of analytical and bioanalytical testing methods including multi-flow cytometry, dose determination assay, cell-based analysis, gene expression profiling
• CAR-T strategies, direct experience with CAR-T programs
• Scientific expertise and leadership to CAR- T teams
• Quality Operations / Quality Systems – implementation of QMS and processes for cell therapy products
• Regulatory requirements pertaining to cell therapy and biologics
• 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
• Filing requirements for cell therapy products
• Novel cellular therapies based on CAR and /or Engineered T Cell Receptor (eTCR) technologies
• Cell biology and high-content data analysis subject matter expertise

Educational / Experience Requirements include:

• M.S. (Ph.D. Preferred) in immunology or molecular and cell biology, bioengineering or related field
• 10+ years of experience in the biopharma industry

Apply to:  http://www.lachmanconsultants.com/career-opportunities/

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.