Director CMC Operations
Abarca HealthFull Time
Senior (5 to 8 years)
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
The Associate Principal Writer for CMC Technical Writing at PTC Therapeutics (PTC) provides CMC technical knowledge and expertise for Chemistry, Manufacturing, and Control (CMC) regulatory document submissions to global health authorities. Responsibilities include authoring, editing, content verification, and providing input to CMC-related documents required for regulatory submissions. The incumbent will collaborate closely with Regulatory CMC Leads, as well as cross-functionally with PTC internal departments and external partners, on CMC technical writing related issues. Additionally, the Associate Principal Writer of CMC Technical Writing will contribute to the development of CMC-related documents in accordance with all applicable regulations including current Good Manufacturing Practices (cGMPs), applicable regulatory guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association [EMA] Clinical Trials Directives, International Congress on Harmonisation [ICH] guidelines), and company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.
Develops therapies for CNS disorders
Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.