CMC Consultant

This fractional consultant position involves guiding the Chemistry, Manufacturing, and Controls strategy for a clinical-stage therapeutics company. Day-to-day tasks include defining development plans to support clinical trials and managing external partners such as CDMOs and CROs. The role requires overseeing drug substance and product development, including formulation optimization, stability testing, and ensuring compatibility with an intradermal self-injection device. Consultants must establish critical quality attributes, specifications, and acceptance criteria while directing analytical method development and validation. They are responsible for selecting and onboarding external vendors, reviewing deliverables, and mitigating technical risks to ensure timelines are met. Additionally, the position involves advising on quality systems and inspection readiness, as well as collaborating with the internal regulatory team to shape the CMC strategy for IND submissions and contribute to related documentation. The advert specifies that the ideal candidate is a senior CMC expert who thrives in a hands-on advisory and execution capacity. It does not list specific software tools, formal educational qualifications, or language requirements. The working arrangement is remote within the United States, structured as a contractor engagement. This role suits individuals comfortable working closely with a lean internal team and external manufacturing partners to advance a lead asset through the NDA pathway.