Job Opportunities API

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 Save and store documentation, generate stability result tables, file stability data and results data Monitor stability due dates and coordinate data transfer from vendors Review analytical documents including but not limited to protocols, reports, and procedures Act as the CMC team analytical representative member in cross functional developmental teams   Contribute to CMC analytical aspects of regulatory filings; review and assemble information for analytical sections in regulatory submission documents (e.g. IND, IMPD, NDA, etc) Coordinate and execute domestic and international shipments Serve as a technical expert and aid in analytical investigations and troubleshooting Assist with batch record review and deviation investigations   Qualifications PhD in Chemistry, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant biotech/pharmaceutical industry experience 10+ years of experience in biotech/pharmaceutical industry in small molecules, working in early to late-development (pre-clinical to phase 3) Strong analytical planning and resource management skills in a dynamic environment located across multiple geographies In depth knowledge of assay and related substances development, forced degradation, HPLC/UPLC, GC, KF, XRPD, residual solvents, elemental impurities, microbial testing, dissolution, compendial methods. Hands-on experience in carrying out stability studies for drug substance and drug product in development and/or QC settings Experience managing DS/DP stability, and knowledge of ICH stability guidelines Knowledge of compendial (USP, EP, etc) requirements and standards Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems Strong organizational skills and attention to detail Good interpersonal and communication skills to collaborate effectively with internal and external business partners Requires a good understanding of managing groups, CMOs, CDMOs and other vendors   Work Location The  Associate Director, Analytical Development  role  is  based in the US, with occasional travel .   Compensation   The annual base salary range for this position is $170,000.00 to