What are the responsibilities and job description for the Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Manager position at Endevica Bio?
Endevica Bio is a clinical-stage biotech located in Northbrook, IL.
Our lead drug (a synthetic peptidomimetic) is due to begin dosing in its first Phase 2 trial in just a few weeks.
We’re now looking towards scale-up and commercialization. CMC is the primary bottleneck in our future plans.
We’re still ahead of the critical path, but we’re definitely starting to sense schedule risk if we keep our current staffing levels. We need to add resources so that we can move faster to settle our CMC plans as we head into pivotal trials in 2026.
Because we’re a small business on a fast growth ramp, we get to build our CMC department from scratch with very talented people. Right now, we’re probably looking for a couple of people that have a solid core of experience with CMC. We get to be flexible on exactly what that experience looks like. We have specific interest in resources with experience in CMC operations management, MSAT (process development, optimization, scale-up, change management, tech transfer), peptide synthesis, formulation development and stability programming, quality (QA, CMC quality oversight, GXP compliance), CDMO management of drug substance and drug product vendors, establishing manufacturing controls, analytical method development and validation, supply chain establishment, packaging / labeling / distribution, CMC regulatory affairs / submissions, and CMC strategic programming.
The general qualifications are straightforward – we’re looking for chemists or chemical engineers with a pharmaceutical and / or pharmaceutical manufacturing background. (The departmental manager is a ChemE PhD.) Experience and education will be key decision points in our hiring and salary-setting process.