Role OverviewThe Associate Director, Analytical Sciences will provide scientific leadership and strategic direction for analytical sciences across the biologics development portfolio. Reporting to the Senior Director, Tech Ops, this individual will establish department-wide analytical strategies, drive late-stage analytical development, and provide technical leadership to ensure robust, phase-appropriate analytical control strategies and analytical methods.
What You Will Do
Establish and evolve the Analytical Sciences strategy to support the company's growing development portfolio. Develop best practices, scientific standards, and analytical governance across programs. Provide scientific leadership for analytical lifecycle management, comparability strategies, method validation, specification development, reference standard strategy, and control strategy development.
Why It Might Be a Fit
We are looking for professionals with the following required skills to achieve our goals: Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years of experience in the Pharmaceutical/Biotech analytical CMC industry, or B.S./M.S. in in Chemical/Biochemical Engineering or related Biological Sciences with 12 years of experience in the Pharmaceutical/Biotech industry analytical CMC industry.
Requirements
- Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years of experience in the Pharmaceutical/Biotech analytical CMC industry, or B.S./M.S. in in Chemical/Biochemical Engineering or related Biological Sciences with 12 years of experience in the Pharmaceutical/Biotech industry analytical CMC industry
- Demonstrated experience advancing biologic products through IND and clinical development
- Experience leading multidisciplinary CMC teams in a matrix environment.
- Experience managing CDMOs and external development partners
- Strong understanding of CMC regulatory expectations for biologic products
- Excellent communication, leadership, and project management skills
]]>