Associate Director, Drug Substance CMC

About this role

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

Description of Role

Centessa is seeking an Associate Director, Small Molecule Drug Substance Process Chemistry. The successful candidate will work closely with their management in directing CDMOs to develop and implement strategies to deliver advanced chemical intermediates and active pharmaceutical ingredients for use in research, GLP and cGMP studies. This individual will work with several internal departments and third-party procurement and distribution providers to align objectives and drive decision-making related to process chemistry and manufacturing. This person will drive the execution of assigned process chemistry activities of Centessa’s small molecule pipeline. Travel to vendors both domestically and internationally may be required.

Key Responsibilities

• Direct CDMO team(s) in manufacturing of advanced chemical intermediates and APIs for GLP studies as well as early and late stage clinical studies.

• Review, approve and issue manufacturing batch records.

• Collaborate with CRO/CDMOs and expert consultants to address process chemistry challenges and develop manufacturing processes that are scalable, safe and cost-effective.

• Support contractor sites via meeting updates, remote and on-site involvement pertaining to OOS/OOT, investigations/deviations, and other pertinent documentation. In addition,…