Our client is an exciting clinical stage drug discovery and development company working on new medicines to improve the quality of life for people with rare and inflammatory diseases. This highly innovative biopharmaceutical company, focused on discovering and developing new therapeutics, is looking for an Analytical Senior Manager with a strong background in analytical method development and validation. This individual will lead all early and late stage analytical development and validation efforts at third party CDMOs towards commercialisation of new drug product(s).
- Management of analytical CMC activities at contract development manufacturing organisations (CDMO), including analytical method development and validation activities.
- Compilation and review of analytical related documentation to support clinical trial Investigational New Drug (IND) and/or Investigational Medicinal Product Dossier (IMPD) submissions and/or New Drug Applications (NDA) in line with Company’s business strategy and timelines.
- Attending and supporting project meetings and regulatory agency meetings.
- The preferred candidate will enjoy a depth of expertise (5-10 + years’ experience in analytical sciences).
- Analytical development experience in pharma a requirement.
- Masters or PhD in relevant analytical discipline an advantage.
- Working knowledge of new and emerging analytical methodologies for testing of drug substances and drug products, including stability testing and shelf-life assignment.
- Knowledge of ICH guidelines as they pertain to analytical development and validation requirements for New Chemical Entities (NCEs).
- Experience of preparation and review of CMC technical reports, CMC dossier sections and Drug Master Files.
- Training on management of CDMOs can be provided to the successful candidate.