Director, Analytical R&D, CMC Small Molecule

COMPANY:

Centessa Pharmaceuticals plc (Nasdaq: CNTA) is a 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.

SUMMARY:

Centessa continues to expand its CMC group and currently seeks a Director of Analytical R&D within the CMC group. The successful candidate will have hands on experience in the development as well as late-stage development. This person 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.

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
• Monitors 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
• Assistance in batch record review
• Assistance in deviation investigations

QUALIFICATIONS:

• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, analytical, and interpersonal skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects
• Demonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical products
• Strong decision-making and analytical skills
• Excellent organizational skills, project management skills and detail-orientated leadership approach
• Must be willing to travel both domestically and internationally
• Strong experience with chemical and physical characterization of small molecules
• Significant experience in analytical method development, qualification/validation for GMP testing including assay & related substances and dissolution
• Direct experience with directing outsourced assay development, stability, and quality control in support of CMC activities
• Experience managing and conducting stability programs, including real time and accelerated/forced degradation
• Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
• Strong understanding and extensive hands-on experience in analytical development, method transfers and method validations
• Understanding of product quality attributes control strategies as applied to small molecule synthetic processes

EXPERIENCE:

• Minimum BS or MS in chemistry, pharmaceutical sciences, or related field preferred; PhD preferred
• >10 years of industry experience in small molecule, working in early to mid-development (pre-clinical to phase 1 and phase 2)
• 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

POSITION: Full-Time, Exempt, Flexibility for Remote Work and Travel

EEOC Statement: Centessa Pharmaceuticals 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. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.