Senior Vice President, CMC & Technical Operations
Hiring Company

The hiring company name is
confidential for this listing.
About the Role
Remote (anywhere in Maryland)
The Company is seeking a senior executive to lead CMC and technical operations through a period of growth. The role will establish the overall CMC strategy and align development timelines with clinical and business objectives. Responsibilities include leading process development, analytical sciences, quality control, and supply chain, while guiding programs from IND-enabling work through clinical development, regulatory submission, and commercialization. The executive will strengthen technical capabilities and infrastructure, ensure appropriate quality and cGMP practices, and provide leadership on regulatory strategy and health-authority interactions. They will also recruit and mentor technical leaders, address complex operational challenges, and partner with senior leadership on priorities and resources. Candidates should hold a Ph.D. or equivalent advanced degree in a relevant scientific or engineering discipline and bring approximately 20 or more years of experience across biopharmaceutical development, CMC, manufacturing, or technical operations, including progressive leadership responsibility. Significant experience leading CMC for complex biologics or technically demanding manufacturing platforms is preferred; cell and gene therapy experience is an advantage. Applicants should have broad expertise across process development, manufacturing, analytical development, quality control, and supply chain, along with the ability to lead multidisciplinary teams while engaging with technical challenges. Experience shaping CMC strategies across development stages and preparing regulatory submissions, including direct interactions with the FDA or other global health authorities, is required. Experience advancing programs from IND-enabling development through BLA approval and commercial launch is highly preferred.
Functions:
- Operations
Compensation
USD $300,000-$450,000 (salary) per year
About the Company
Clinical-stage biotech growing its pipeline from IND-enabling development through commercialization
Industry
Biotechnology
Type
Privately Held