Associate Director, Drug Substance CMC

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, provide on-site presence during active manufacturing campaigns, as needed.
• Prepare presentation materials and clearly communicate progress, challenges and potential risk in API manufacturing to management in real time or weekly basis, as needed.
• Author and review technical reports, tech transfer packages, and GMP production records as well as CMC sections regulatory related documentation (ie. INDs) submission, and any documents related to intellectual property.
• Assist with new vendor assessment and selection by providing technical review of CDMO resources, capacities, and capabilities as appropriate for development needs. <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":