Associate Director CMC

We are looking for an Associate Director, Chemistry Manufacturing and Controls (CMC) to join our A-team. As an Associate 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. The specific experience for CMC is small molecule (solid, liquid, oral, topical, injectable (sterile products), inhalation. We are mainly focused on pre-approval products. Responsibilities may include analysis/review of drug substance synthesis, pre-formulation and formulation evaluation, analysis of manufacture, scale-up and process validation, providing support of analytical methods development and validation, and evaluation of packaging and labeling components. The CMC Associate Director leads and/or participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The CMC Associate Director reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, and other scientific documents.   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. In this role your key tasks will include: Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought  Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development  Guides the writing of regulatory/scientific documents written by other project team members  Has advanced scientific knowledge of HA Regulatory Guidance and Regulations  Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and prepa