What are the responsibilities and job description for the (Sr)Director, Analytical Development & Stability position at Torrey Pines Solutions?
About the job (Sr)Director, Analytical Development & Stability
ESSENTIAL JOB FUNCTIONS :
- Responsible for all management aspects of Analytical R&D and Stability from lead optimization into clinical development through validation for commercialization.
- Will serve as the subject matter expert and lead the analytical research and development / stability study / QC functions with internal and external CRO / CDMOs.
- Provided direction, leadership, and oversight for all analytical methods development and validation, stability and quality control elements at contract research laboratories and manufacturing organizations.
- Guide external third parties to perform analytical activities in support of technology transfer, process development, optimization, qualification, and validation related to Drug Substance and Drug Product manufacturing operations.
- Provide oversight for the transfer of preclinical analytical methods from Research through all clinical phases of development and into QC at commercial manufacturing sites.
- Author and review CMC sections for all regulatory filings (INDs, IMPDs, NDAs, MAAs).
- Provide strategic support and technical documentation for answering regulatory questions during submission reviews and throughout clinical development.
- Responsible for Analytical Development and Stability budget recommendations and management of associated expenses.
- Provide direction and leadership for Analytical Research & Development and Stability staff.
JOB REQUIREMENTS :
