Associate Director, Analytical Sciences, Biologics CMC & Tech Ops
Overview
Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years in Pharmaceutical/Biotech analytical CMC, or a BS/MS with 12+ years in analytical CMC. You will lead analytical sciences strategy for biologics development, drive late-stage analytical development, and prepare for regulatory submissions including BLA. You will collaborate across functions to ensure phase-appropriate characterization and robust control strategies while guiding external partners and CROs.
What You'll Do10
- 1Build and evolve the Analytical Sciences strategy to support the growing development portfolio across programs
- 2Lead technical governance for analytical lifecycle management, comparability, method validation, specification development, and control strategy development
- 3Drive late-stage analytical planning including process validation, commercial readiness, and regulatory submissions
- 4Lead cross-functional collaboration with Analytical Project Leads and other functional groups to ensure integrated CMC strategies
- 5Partner with external laboratories and CROs, oversee technology transfers and due diligence, and manage regulatory inspections
- 6Provide mentorship to scientists, building a high-performing analytical organization
- 7Identify opportunities to strengthen capabilities, technologies, and external partnerships
- 8Support portfolio planning by identifying cross-program risks and resource needs
- 9Evaluate emerging analytical technologies and determine implementation strategy
- 10Ensure phase-appropriate characterization and alignment with BLA timelines
Requirements6
- 1Ph.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. with ≥12 years in the Pharmaceutical/Biotech analytical CMC field
- 2Demonstrated experience advancing biologic products through IND and clinical development
- 3Experience leading multidisciplinary CMC teams in a matrix environment
- 4Experience managing CDMOs and external development partners
- 5Strong understanding of CMC regulatory expectations for biologic products
- 6Excellent communication, leadership, and project management skills
Salary Insight
$165 - $220k per year
Location
Required Skills
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