Business Services & Consulting • all cities, FL 10
Directeur principal, CMC/Sr. Director, CMC (10)
all cities, FL 10On-sitePosted 1 day ago
Business Services & Consulting
About the Role
Director, Cmc
Chez 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 Director, CMC to join our A-team (hybrid*/remote) in Canada. As a Director, 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.
As the Director, CMC, 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 with a focus on scientific aspects.
Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
Prepare product development plans from early development through Phase 4.
Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
Perform other scientist related duties, as needed.
Director, Cmc
Chez 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 Director, CMC to join our A-team (hybrid*/remote) in Canada. As a Director, 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.
As the Director, CMC, 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 with a focus on scientific aspects.
Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
Prepare product development plans from early development through Phase 4.
Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
Perform other scientist related duties, as needed.
What You'll Do
Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
Prepare product development plans from early development through Phase 4.
Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
Perform other scientist related duties, as needed.
