Biologics Consulting is seeking to hire a CMC expert in analytical method development and validation for Cell, Tissue and Gene Therapeutic products. Experience with bioanalytical method development and validation for clinical sample analysis is a plus. The preferred candidate should have an M.S. or Ph.D. (in a biological or health-related science) with experience with in-process and QC release method development and validation for cellular, tissue and/or gene therapies, and at least 5 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 method development and validation 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 analytical and bioanalytical method development, validation 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, analytical method improvement recommendations, regulatory advice, and organizational assessments. Additional responsibilities may include strategic or operational oversight of client analytical 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.
Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. In the twenty-five years since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients internationally to address nonclinical, clinical, product development and manufacturing, and regulatory compliance challenges.
The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience. Biologics Consulting offers a great work environment, as well as a highly competitive salary and benefit package, including healthcare, 401k, and ESOP plans.
Biologics Consulting is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/reassignment, citizenship, pregnancy or maternity, veteran status, or any other status protected by applicable national, federal, state or local law.