Director, Analytical Development & CMC Compliance
The Director, Analytical Development & CMC Compliance at Cytokinetics is a strategic technical leader responsible for guiding analytical development strategies and ensuring compliance with global regulatory standards. This role is integral to the company's mission of developing first-in-class muscle activators and inhibitors for cardiovascular diseases. The position is based in Dublin, Ireland, and involves close collaboration with Manufacturing, Process Development, Regulatory CMC, and Quality Assurance teams.
Key responsibilities include leading the development, qualification, and lifecycle management of analytical methods and control strategies aligned with ICH guidelines. The Director will oversee analytical development activities across all phases of clinical development, manage GMP testing for raw materials, in-process materials, drug substances, and drug products, and ensure timely release and stability testing. Additionally, the role involves managing external laboratories and CDMOs to ensure compliance and adherence to project timelines.
The ideal candidate will possess a Ph.D. or equivalent in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field, with over 10 years of experience in pharmaceutical or biotech analytical development. Demonstrated experience in supporting regulatory submissions such as INDs and NDAs/MAAs, as well as direct interactions with global health authorities, is essential. Technical expertise in chromatography (HPLC, UPLC, GC), mass spectrometry, stability studies, and method development, validation, transfer, and lifecycle management is required.
Cytokinetics offers a competitive compensation package, including benefits and perks designed to support the well-being and professional growth of its employees. The company fosters a collaborative and innovative culture, providing opportunities for career advancement and the chance to contribute to groundbreaking developments in cardiovascular therapeutics.