Sr. Director, CMC

Allucent•Cary, NC

1d•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 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.

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
Experience in pre-approval products; large biologics experience required.
Line management experience required.
Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
Strong emotional intelligence, customer focused leadership and decision-making skills
Innovative, creative, and practical thinking including problem-solving skills
>10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable

Nice To Haves

Prior CRO experience preferred.

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 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.