Senior Director, Analytical Development and Quality Control; Molecules

The Senior Director, Analytical Development & Quality Control (Small Molecules) provides strategic and operational leadership for all analytical activities supporting drug substance and drug product development, clinical supply, commercial manufacturing, and lifecycle management. This leader is accountable for building and executing robust analytical strategies, ensuring regulatory compliance, and leading internal teams and external partners to deliver high quality analytical data across all development stages.

The role serves as a key CMC partner to Process Development, Manufacturing, Quality, Regulatory Affairs, and external CDMOs, and plays a critical leadership role in regulatory filings, inspections, and post‑approval commitments.

• Define and execute the analytical development and QC strategy across early development, late-stage clinical, and commercial lifecycle.
• Build scalable, phase‑appropriate analytical control strategies aligned with global regulatory expectations (FDA, EMA, ICH).
• Serve as the analytical subject matter expert on CMC core teams and governance forums.

• Lead development, qualification, validation, and transfer of analytical methods for drug substance, drug product, in‑process, and stability testing.
• Ensure methods are robust, stability‑indicating, and fit for intended use across lifecycle stages.
• Drive adoption of new technologies (e.g., advanced characterization, automation, digital data integrity solutions) where appropriate.

• Provide oversight of internal and external QC testing labs supporting clinical and commercial programs.
• Ensure compliance with cGMP, data integrity, and quality system requirements.
• Oversee investigations, OOS/OOT events, troubleshooting methods, and CAPA implementation.

• Author, review, and approve analytical sections of INDs, NDAs/BLAs, MAAs, and global regulatory submissions.
• Act as analytical lead during health authority inspections, audits, and agency interactions.
• Support responses to regulatory questions, commitments, and post‑approval changes.

• Lead analytical/QC oversight of CDMOs, CROs, and external testing laboratories.
• Establish performance metrics, governance models, and continuous improvement plans with partners.
• Ensure successful method transfer, validation, and ongoing compliance at external sites.

• Build, mentor, and develop high‑performing analytical and QC teams.
• Establish clear organizational structure, talent development plans, and succession planning.
• Foster a culture of scientific excellence, quality, and accountability.

• Partner closely with Process Development, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and Program Management.
• Support technical due diligence, lifecycle management, and CMC innovation initiatives.

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline

• 15+ years of experience in analytical development and/or QC within the biopharmaceutical or pharmaceutical industry.
• 7+ years in people leadership roles with experience building and scaling teams.
• Direct experience supporting late‑stage development and commercial products.
• Strong track record of regulatory interactions and successful submissions.
• Provide scientific and operational leadership across all phases of drug development—from early phase through commercial launch.
• Lead method development, qualification, validation, and transfer for drug substances and drug products (small molecules, peptides, biologics).
• Oversee characterization studies, impurity profiling, and forced degradation assessments.
• Ensure robust analytical control strategies are in place to support product lifecycle management.
• Manage QC testing for raw materials, intermediates, drug substances, and drug products across internal and external labs.
• Ensure timely and compliant release testing, stability program execution, and reference standard qualification.
• Author and review analytical sections of regulatory submissions…