Analytical Development, Chemistry, Clinical Trial, Customer Support/Service, Drug Development, Drug Products, FDA (Food and Drug Administration), ICH Regulations, Maintain Compliance, Manufacturing, Medical Equipment, Medical Products, People Management, Performance Management, Product Development, Regulations, Regulatory Requirements, Regulatory Submissions, Training/Teaching
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 Sr. Director, CMC to join our A-team (hybrid*/remote) in the USA. As a Sr. 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
About the role
As the Sr. 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.