Director, Analytical Strategy (Recombinant)

The Analytical Strategy Director is a senior scientific and strategic leadership role responsible for designing and overseeing analytical strategies that support drug discovery development and regulatory approval. This position ensures robust compliant and innovative analytical approaches across preclinical clinical programs and LCM.

Main Responsibilities & Accountabilities

Strategic Leadership:

• Develop and lead the global analytical strategy aligned with program and corporate goals
• Provide scientific and regulatory guidance for analytical plans across all development phases (discovery post-marketing)
• Drive innovation in analytical technologies platforms and workflows
• Represent analytical function in cross-functional governance and decision-making forums

Scientific Oversight:

• Oversee development validation and implementation of analytical methods (e.g. LC-MS/MS ligand binding assays biomarkers immunogenicity)
• Ensure high-quality data generation for PK PD biomarker and immunogenicity studies
• Review and approve analytical study designs reports and regulatory documentation
• Troubleshoot complex scientific and technical challenges

Regulatory & Compliance:

• Ensure compliance with global regulatory guidelines (FDA EMA ICH GLP GCP)
• Lead analytical sections of regulatory submissions (IND CTA NDA BLA MAA)
• Interface with regulatory agencies and respond to health authority queries
• Maintain inspection readiness and quality standards

Cross-Functional Collaboration:

• Partner with Clinical Pharmacology DMPK Toxicology Biomarkers and Clinical Operations
• Support translational strategy and dose selection decisions
• Manage external CROs academic collaborators and technology vendors

Leadership & Management:

• Lead and mentor analytical scientists and project leaders
• Manage budgets timelines and resource allocation
• Build and scale analytical capabilities and infrastructure

Qualifications & Experience Requirements

• PhD in analytical Chemistry Pharmaceutical Sciences Biochemistry or related field (or MSc with extensive experience)
• Typically 1215 years in bioanalysis within biotech pharma or CRO environments
• Deep expertise in LC-MS/MS ligand binding assays biomarkers and immunogenicity testing
• Strong knowledge of regulatory requirements and analytical validation standards
• Proven leadership and strategic program experience
• Experience supporting regulatory submissions and health authority interactions

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Director