Director, Analytical Strategy (recombinant)

CSL

Not specified (assumed hybrid based on industry standards)
Phd in analytical chemistry or related field
12-15 years bioanalysis experience
Expertise in lc-ms/ms and ligand binding assays
CSL is seeking a Director of Analytical Strategy to lead the development and oversight of innovative analytical strategies supporting drug discovery and regulatory approval. The ideal candidate will possess extensive experience in bioanalysis, regulatory compliance, and scientific leadership

Job Summary

  • This senior role is responsible for designing and overseeing global analytical strategies that support drug discovery, development, and regulatory approval across all phases.
  • The successful candidate will lead the development and validation of complex analytical methods including LC-MS/MS, biomarkers, and immunogenicity testing to ensure high-quality data generation.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies in immunology, hematology, and other therapeutic areas.

Matching Summary

Match Score: 85

CSL is seeking a Director of Analytical Strategy to lead the development and oversight of innovative analytical strategies supporting drug discovery and regulatory approval. The ideal candidate will possess extensive experience in bioanalysis, regulatory compliance, and scientific leadership.

Skills & Requirements

Must-have

  • PhD in analytical chemistry or related field
  • 12-15 years bioanalysis experience
  • Expertise in LC-MS/MS and ligand binding assays
  • Regulatory submission leadership (IND, NDA, BLA)
  • Global analytical strategy development

Nice-to-have

  • Experience managing external CROs and vendors
  • Cross-functional collaboration skills
  • Innovation in analytical technologies
  • Mentoring senior scientific teams

Key Requirements

  • PhD required (or MSc with extensive experience)
  • 12-15+ years in bioanalysis within pharma/biotech
  • Proven track record in regulatory submissions
  • Deep knowledge of FDA, EMA, ICH guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter