(Sr)Director, Analytical Development & Stability
Torrey Pines Solutions
(Sr)Director, Analytical Development & Stability
San Diego, California, United States
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:
- BS with 15 + yrs., MS with 12+ yrs., or Ph.D. with 10+ yrs. in analytical sciences or related field.
- 8+ years of relevant industry experience in analytical development and stability.
- Demonstrated experience in QC/QA regulations.
- Familiar with cGMP compliance and ICH guidelines.
- Experience and management of outsourced projects with contractors.
- Strong leadership, teamwork, and collaboration skills.
- Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment.
- Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.
Vacancy posted 3 days ago
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