Biologics Consulting is seeking to hire an expert in cellular, tissue and gene therapeutic products. The preferred candidate should have a Ph.D. (in a biological or health-related science) or an MD with experience in cellular, tissue and gene therapies, and at least 5 or more years of experience within the biotechnology industry, clinical laboratories, 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 the development of regulatory strategies to facilitate rapid development of cell, tissue and gene-based therapies.
The incumbent is expected to provide comprehensive scientific and technical strategic guidance in clinical and product development, GMP/GTP manufacturing, and regulatory compliance in the area of cell, gene and tissue therapies. Other responsibilities may include writing regulatory submissions (pre-IND briefing packages, INDs, and BLAs/NDAs). 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.
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