[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

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