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[Remote] Associate Director, Analytical Development – Small Molecule
Note The job is a remote job and is open to candidates in USA. Centessa Pharmaceuticals is a new kind of pharmaceutical company focused on data-driven decision making and advancing a portfolio of high conviction programs. They are seeking an Associate Director of Analytical R&D to lead small molecule analytical activities across early to late-stage development, overseeing vendor work and ensuring compliance with regulatory guidance. 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 Skills 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 Benefits Discretionary annual bonus 401(k) plan Company-sponsored medical, dental, vision, and life insurance Generous paid time off Health and wellness program Company Overview Centessa Pharmaceuticals is a pharmaceutical company that focuses on drug development to address significant medical needs. It was founded in 2021, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 51-200 employees. Its website is https//www.centessa.com. Company H1B Sponsorship Centessa Pharmaceuticals has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2024. Please note that this does not guarantee sponsorship for this specific role.
