Senior Manager/ Director, Analytical Development
The candidate should be an expert in biological product development through commercialization with hands on experience of method development and validation. In addition, the candidate is expected to have experience in all analytical related BLA enabling 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.
These may include, but are not limited to, the following; other duties may be assigned
- 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.
Education & Experience
- PhD in Analytical Chemistry or related disciplines
- 10+ years of in-depth biotechnology technical experience in protein analytical development for biologics from lead selection to clinical development and commercial launch
- Hands on experience on analytical technologies such as HPLC, CE, peptide map, mass spectrometry, ELISA, and cell-based bioassay is required.
- Significant experience with protein characterization and comparability assessment is essential.
- Direct experiences on transfer of analytical methods to CMO’s is required.
- Extensive experiences on authoring analytical sections for regulatory submissions.
- 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.
- Excellent interpersonal communication and presentation skills.
- Position may require occasional evening and/or weekend commitment
- Position may require working with biological and/or chemical hazards
- Position may require occasional travel (~25%), domestic and international.