CMC Consultant

About the role

We are seeking experts in Analytical Development, Process Development, and Drug Substance/Drug Product Science to help us design and build tasks that will evaluate the capabilities of AI tools in regulatory submission processes.

Responsibilities

• Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions.
• Description of common tasks or problems where AI could be of value in your workflows.
• Identification and description of internal pharma systems that are commonly used for standard workflows.
• Generation or review of reference ground-truth artifacts to evaluate against - reports, data files, modules, etc.
• Identification and correction of discrepancies in data quality.

Qualifications

• 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.

Why join us?

• Remote/US based
• Flexible hours / flexible time zone - 5-20 hours per week
• 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
• Pet care support with a yearly employer-funded stipend for your animal companions
• Commuter benefits so you can pay for transit and parking with pre-tax dollars
• 401(k) company matching
• $300 health and wellness benefit quarterly
• 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

Edison Scientific is an equal opportunity employer.

We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.