(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:

• 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.