About the job
At Allucent, we are committed to empowering small to medium-sized biopharmaceutical companies in successfully navigating the intricate landscape of clinical trials, ensuring that transformative therapies reach patients worldwide.
We are currently seeking a contractual Vice President of Chemistry, Manufacturing, and Controls (VP CMC) to become a vital part of our elite team (hybrid/remote). In this role, you will leverage your expertise to support clients in Chemistry, Manufacturing, and Control (CMC) as well as related pharmaceutical development initiatives for drugs, biologics, and medical device products.
Role Overview
As the VP CMC, you will serve as the primary subject matter expert, collaborating cross-functionally and globally with both internal teams and external clients. Your responsibilities will include:
- Leading comprehensive CMC strategies covering drug substance, drug product, and analytical development from early-stage evaluation to regulatory submission and commercial launch.
- Ensuring regulatory excellence through the authorship and review of CMC submissions, managing communications with Health Authorities, and guaranteeing adherence to FDA, EMA, and ICH guidelines.
- Overseeing essential development activities such as process development, scale-up, manufacturing validation, analytical method development, and packaging/labeling assessments.
- Facilitating cross-functional collaboration as a Subject Matter Expert and Technical Lead, working with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure smooth program execution.
- Advocating for quality and compliance by applying Quality by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and commercial success.
- Building and mentoring high-performing teams while managing budgets and timelines to provide robust, scalable, and cost-effective pharmaceutical solutions.
This position is open to candidates from the United States, Canada, EU member countries, and the United Kingdom.