VP CMC/Senior Strategist CMC (Contractor)

Allucent

8h•Hybrid

About The Position

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Vice President of Chemistry, Manufacturing, and Controls (VP CMC) contractor to join our A-team (hybrid/remote). As a VP CMC at Allucent, you are responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. About the role As the VP CMC, you are the subject matter expert who will work cross-functionally and globally with internal team members and external clients. You will: Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines Oversee critical development activities including process development, scale-up, manufacturing validation, analytical method development, and packaging/labeling evaluation Manage cross-functional collaboration as a Subject Matter Expert and Technical Lead, partnering with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure seamless program execution Champion quality and compliance by implementing Quality by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and commercial success Build and mentor high-performing teams while managing budgets and timelines to deliver robust, scalable, and cost-effective pharmaceutical solutions This role is open to considering candidates from United States, Canada, Countries within the EU, and United Kingdom.

Requirements

Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
Advanced scientific and regulatory knowledge of drug, biologic, or device development
>15 years’ post-degree of directly relevant experience in drug, biologic, or device development preferred
Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
Quality focus
Strong emotional intelligence, customer focused leadership and decision-making skills
Innovative, creative, and practical thinking including problem-solving skills

Responsibilities

Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch
Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines
Oversee critical development activities including process development, scale-up, manufacturing validation, analytical method development, and packaging/labeling evaluation
Manage cross-functional collaboration as a Subject Matter Expert and Technical Lead, partnering with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure seamless program execution
Champion quality and compliance by implementing Quality by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and commercial success
Build and mentor high-performing teams while managing budgets and timelines to deliver robust, scalable, and cost-effective pharmaceutical solutions