Associate Director, Analytical Development – Small Molecule

Description of RoleCentessa continues to expand its CMC group and currently seeks a Associate Director of Analytical R&D within the CMC group. The successful candidate will have hands‐on experience leading 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 ResponsibilitiesSupport analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple programsWork 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 projectsReview method validation protocols, reports, and transfer activitiesReview test data for release, stability, and characterization plans for projectsSave and store documentation, generate stability result tables, file stability data and results dataMonitor stability due dates and coordinate data transfer from vendorsReview analytical documents including but not limited to protocols, reports, and proceduresAct as the CMC team analytical representative member in cross functional developmental teamsContribute 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 shipmentsServe as a technical expert and aid in analytical investigations and troubleshootingAssist with batch record review and deviation investigationsQualificationsPhD in Chemistry, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant biotech/pharmaceutical industry experience10+ years of experience in biotech/pharmaceutical industryin 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 geographiesIn 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 settingsExperience managing DS/DP stability, and knowledge of ICH stability guidelinesKnowledge of compendial (USP, EP, etc) requirements and standardsDetailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systemsStrong organizational skills and attention to detailGood interpersonal and communication skills to collaborate effectively with internal and external business partnersRequires a good understanding of managing groups, CMOs, CDMOs and other vendorsWork LocationThe Associate Director, Analytical Development role is based in the US, with occasional travel.CompensationThe annual base salary range for this position is $170,000.00 to $195,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company‐sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.POSITIONFull‐Time, ExemptEEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies. #J-18808-Ljbffr