Senior Director, Analytical Development and Quality Control

📋 Description

• Lead strategic direction and execution of analytical development and quality control for biologics
• Define long-term strategy, governance, and external partner network for biologics analytics from
• Oversee phase-appropriate control strategies, including method development, qualification
• Represent analytical/QC to CDMO, contract labs, and cross-functional teams; ensure inspection
• Build and lead a high-performing analytical organization; manage budget, resources, and external
• Drive technology adoption, KPI governance, and continuous improvement across analytical operations.

🎯 Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field with 15+
• Deep expertise in analytical development and QC for biologics (antibodies, fusion proteins, complex
• Proven track record delivering analytical strategies from lead candidate to commercialization
• Extensive experience with method development/transfer/validation, specifications, comparability
• Strong leadership in outsourced models with CDMOs and external labs; GMP, data integrity, and
• Excellent communication, cross-functional leadership, and strategic business acumen.

🎁 Benefits

• Competitive base salary with annual bonus eligibility and equity compensation.
• Comprehensive benefits package.
• Opportunity to influence late-stage development and global regulatory readiness.
• Collaborative, cross-functional environment with external partners.