Associate Director, Analytical Development - Small Molecule

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

Requirements

• 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 .

Benefits

Additional Information

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. 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 .

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