This senior role is responsible for designing and overseeing global analytical strategies that support drug discovery, development, and regulatory approval
Job Summary
This senior role is responsible for designing and overseeing global analytical strategies that support drug discovery, development, and regulatory approval.
The successful candidate will lead the analytical sections of major regulatory submissions including IND, NDA, BLA, and MAA while ensuring compliance with global guidelines.
CSL Seqirus offers a culture of inclusion and belonging where diverse workforces are celebrated to sustain innovation and address unmet medical needs.
Matching Summary
This senior role is responsible for designing and overseeing global analytical strategies that support drug discovery, development, and regulatory approval.
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
Deep knowledge of FDA EMA ICH regulatory guidelines
Proven track record leading analytical teams
Nice-to-have
Experience managing external CROs and vendors
Strong background in biomarker and immunogenicity testing
Ability to drive innovation in analytical workflows
Cross-functional partnership with Clinical Pharmacology
Key Requirements
PhD in analytical Chemistry, Pharmaceutical Sciences, or Biochemistry
12-15+ years of experience in bioanalysis within biotech or pharma
Extensive experience supporting regulatory submissions and health authority interactions