CMC Consultant

About reputed company builds and commercializes AI agents for science. Scientific discovery moves too slowly, and autonomous AI agents are how we intend to fix that. We're assembling a team of top researchers and engineers across AI and biology to build an AI scientist. The Opportunity We want to reputed company our tools reputed company at the things you are an expert at, so that they can be deployed to reputed company and accelerate the productivity of people like you. An important part of doing this is building reputed company variably refer to as evals or benchmarks - essentially “exams” that are used to measure how good AI tools are at carrying out important tasks. Right now we are particularly interested in work surrounding regulatory submissions like INDs and reputed company that goes into them. We are looking for experts in CMC Regulatory Affairs, CMC Regulatory Writing/ Medical Writing, Analytical Development, Process Development, CMC Project Management, and Drug Substance/Drug Product Science. We engage with domain experts to help design and build these tasks, and help us know reputed company don’t know. Day to day that might look like any or reputed company of the following sorts of activities (and more): Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions. Describing common tasks or problems where AI could be of value in your workflows. Identify + describe internal pharma systems that are commonly used for standard workflows. Generate or review reference ground-truth artifacts to evaluate against - reports, data files, modules, etc. Identify + add realistic sources of variance or data corruption in study data. Identify and correct discrepancies in data quality. Qualifications 10+ years of experience reputed company the pharmaceutical/biotechnology industry, ideally with a sponsor. Strong foundational knowledge and hands-on experience in CMC (Chemistry, Manufacturing, and Controls), including drug substance and drug product characterization, analytical methods, and stability requirements. Bachelor's Degree required; Advanced degree preferred (Chemistry, Pharmaceutical Sciences, Biochemistry, or reputed company field) Experience supporting and/or authoring Module 3 of at least 10 IND’s. Strong understanding of ICH guidelines and experience interfacing with FDA, including responding to CMC-reputed company information requests. Strong technical writing skills with the ability to translate reputed company scientific data into clear regulatory narratives Why join us? Remote/US based reputed company / flexible time zone - 5-20 hours per week Note: For consulting opportunities, we do not offer benefits. Why join us? Competitive salary and equity Full reputed company coverage — we pay 100% of premiums for you and your dependents Support for growing families, including a yearly new parent stipend and fertility coverage through reputed company 401(k) company matching $300 health and wellness benefit Lunch is on us every day you're in the office, and dinner is on us reputed company you're working late Regular team offsites and company events A fast-moving, mission-driven culture where smart people do their best work and actually enjoy doing it reputed company is an equal opportunity employer. We do not discriminate on the basis of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, age, disability, veteran status, or any other protected characteristic under applicable law. Apply To This Job