CMC Consultant
About The Position
Edison Scientific 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. We want to make our tools better at the things you are an expert at, so that they can be deployed to amplify and accelerate the productivity of people like you. An important part of doing this is building what we 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 all 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 what we don’t know. Day to day that might look like any or all 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.
Requirements
- 10+ years of experience within 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 related 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-related information requests.
- Strong technical writing skills with the ability to translate complex scientific data into clear regulatory narratives
Responsibilities
- 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.
Benefits
- Competitive salary and equity
- Full healthcare 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 Carrot
- 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 when 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
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What This Job Offers
Job Type
Part-time
Career Level
Senior
Education Level
Associate degree
