Senior Consultant, CMC

Senior Consultant, CMC

Biologics Consulting is seeking to hire a CMC expert in Cell, Tissue and Gene Therapeutic products.  The preferred candidate should have an M.S. or Ph.D. (in a biological or health-related science) with experience in cellular, tissue and/or gene therapies, and at least 10 or more years of experience within the biotechnology industry and/or a national regulatory authority such as the US Food and Drug Administration.  This position involves working as a consultant directly with biopharmaceutical companies to provide consultation for CMC-Development, Manufacturing, and Regulatory Strategy to facilitate the rapid development of cell, tissue and gene-based therapies.

The incumbent is expected to provide high-quality, comprehensive scientific, technical and regulatory guidance for the client in product and process development, GLP/GMP manufacturing, and compliance in the areas of cell, tissue and gene therapies.  The consultant may work independently or serve as part of a multi-disciplinary team.

Responsibilities may include pre- and post-product assessment, cGMP assessment, remediation planning, product and process improvement recommendations, regulatory advice, and organizational assessments.  Additional responsibilities may include strategic or operational oversight of client activities, and supporting the preparation, review, and management of US FDA regulatory submissions.  Excellent written and verbal communication skills are required.

This is a full-time, salary plus performance-based bonus position.