(Sr)Director, Analytical Development & Stability
torrey pines solutionsSan Diego (CA)
(Sr)Director, Analytical Development & Stability
Posted today
torrey pines solutionsSan Diego (CA)
SENIORITY
Manager
About the role
(Sr) Director, Analytical Development & Stability San Diego, California, United StatesESSENTIAL 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.
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