Associate Director, Analytical Development – Small Molecule

Description of Role

Centessa continues to expand its CMC group and currently seeks a n Associate Director of Analytical R&D within the CMC group . The successful candidate will have hands-on experience lead ing the execution of small molecule analytical activities across early to late-stage development. This position will oversee work with various vendors and oversee analytical functions across programs . Comprehensive working knowledge of cGMP and regulatory guidance as they relate to development, testing, characterization, and shelf-life management of biologics is paramount . This position will be accountable for design, execution, and reporting of analytical data at external CDMOs to meet company deliverables and timelines . Travel to vendors both domestically and internationally will be required .

Key Responsibilities

• Support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programs
• Work in a team environment to manage drug substance and drug product analytical development activities primarily at third-party vendors including analytical method implementation, qualification/validation, and transfer for drug substance and drug product projects
• Review method validation protocols, reports, and transfer activities
• Review test data for release, stability, and characterization plans for projects <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"46976922