Director of Analytical Development (Biologics)

Key Responsibilities

• Lead analytical development strategy for late-stage biologics programs, including Phase II/III and commercial readiness
• Oversee method validation, transfer, and lifecycle management in alignment with ICH guidelines (Q2, Q6, Q14)
• Drive analytical support for regulatory submissions, including IND amendments, BLA/MAA filings, and responses to health authority questions
• Partner with Drug Substance, Drug Product, and Quality teams to ensure robust control strategies and specifications
• Provide oversight of CDMOs and external testing laboratories, ensuring timelines, data quality, and compliance
• Support comparability, stability, and characterization strategies for process changes and scale-up
• Act as a key contributor during inspections and audits (FDA, EMA, etc.)
• Build, mentor, and scale a high-performing analytical team as programs advance toward commercialization

Qualifications

• PhD (preferred) or MS in Analytical Chemistry, Biochemistry, or related field
• ~10-15+ years of analytical development experience in biologics (monoclonal antibodies, proteins, or related modalities)
• Strong expertise in late-stage development, method validation, and regulatory filings (BLA/MAA)
• Deep knowledge of analytical techniques (e.g., HPLC/UPLC, CE, MS, bioassays, impurity profiling)
• Proven experience managing external partners (CDMOs/CROs)
• Familiarity with global regulatory expectations and inspection readiness
• Prior leadership experience with the ability to influence cross-functional stakeholders