Sr. Manager or Director of Analytical Development
Adagene is seeking a Director or Sr. Director of Analytical to lead analytical and characterization function. This position reports to Chief Manufacturing Officer. The title of the position will depend on the qualification and experience of the candidate.
The candidate should be an expert in biological product development through commercialization with hands on experience of method development and validation. In addition to the candidate is expected to have the experience in all analytical related BLA enable studies such as analytical method validation, comparability, elucidation of structure, impurity characterization and justification of specification. The candidate should have strong technical, communication and interpersonal skills. The candidate will collaborate with other functional leaders from Bioprocess, Formulation, Supply Chain, CMO management and Quality in support of the project teams and of the organization.
- Lead and support analytical method development and validation at CMO facilities
- Define and develop physiochemical and functional assays to support process and product development as well as product release.
- Manage and supervise analytical experimental design, execution and writing testing methods and validation protocols/reports.
- Works closely with colleagues in bioprocess to ensure timely analytical support for cell line, process and formulation development.
- Oversee comparability strategies and CQA assessments
- Work with QA and CMC function leads to establish product specifications.
- Review and approve CMO qualification/validation protocols and reports
- Participating deviation investigation and CAPA establishment; address testing related issues at CMO’s in collaboration with Quality.
- Manage reference standards and oversee critical reagent strategy.
- Responsible for design, plan and execute all analytical related BLA enable studies.
- Collaborate with QA and Regulatory to support batch releases and regulatory submissions.
- Ph.D. degree in analytical chemistry, biochemistry or related relevant field and 8+ years of relevant industry experience or BS/MS degree and 10+ years of biological analytical method development & validation experience.
- Significant experience with protein characterization and comparability assessment is essential.
- Direct experiences on transfer of analytical methods to CMO’s is required.
- Experiences with method validation, process validation and BLA submission is strongly preferred
- Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- The position can be US or China location (may require traveling to China for US based)