Associate Director, Analytical Strategy

CSL; King of Prussia (PA); Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

CSL is seeking two Associate Director level scientists to design and oversee analytical strategies for product development and lifecycle management across pre-clinical to commercial stages. The roles have global reach and may be based at sites in Bern, Marburg, King of Prussia, Waltham or Melbourne.

Responsibilities include developing global analytical strategies, guiding regulatory filings, and driving innovation in analytical platforms, with leadership across Manufacturing, QA/QC, Research,

Qualifications

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience).
• Typically 8+ years in bioanalysis within biotech, pharma, or CRO/CDMO environments.
• Deep expertise in analytical development, product specification testing, characterisation, and data analysis.
• Demonstrated knowledge of regulatory requirements and analytical validation standards.
• Proven leadership and strategic program experience ideally in a global matrix environment.
• Experience supporting regulatory submissions and health authority interactions.
• Excellent communication skills including presenting complex information to non-scientific stakeholders.

Responsabilités

• Developing global analytical strategies for assigned products aligned with program and corporate goals.
• Provide scientific and regulatory guidance for analytical plans across all product development and LCM phases Drive innovation in analytical technologies, platforms, and workflows.
• Reviewing analytical study designs, reports, and regulatory documentation.
• Oversee development, validation, characterisation and implementation of analytical methods.
• Ensure high-quality data generation for product development and LCM programs.
• Troubleshoot complex scientific and technical challenges.
• Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GMP) and interface with regulatory agencies, responding to health authority queries.
• Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)
• Maintaining inspection readiness and quality standards.
• Partnering with internal stakeholders across Manufacturing, Quality Control, Quality Assurance, Research and external partners such as CROs/CDMOs, academic collaborators and technology vendors.

Connaissances

Leadership

Strategic thinking

Regulatory knowledge

Communication

Team collaboration

Formation

PhD in Analytical Chemistry or related field

Description du poste

CSL’s world-class R&D organisation continues to evolve as a biotechnology leader by advancing high-quality science and technology across five therapeutic areas being Immunoglobulins, Haematology, Cardiovascular & Renal, Transplant & Immunology and Vaccines that will make a meaningful difference to the lives of patients with rare and serious diseases.

CSL is now seeking two Associate Director level scientists to design and oversee analytical strategies that support product development and lifecycle management (LCM).

The Associate Director Analytical Strategy ensures the deployment of robust, compliant, and innovative analytical approaches across pre-clinical and clinical development as well as LCM for commercial products.

These are key senior scientific and strategic leadership roles supporting a diverse portfolio of recombinant protein and gene therapy products from early development, through licensure and ongoing commercial operations.

These positions have global reach and could be based at either of our sites in Bern, Marburg, King of Prussia, Waltham or Melbourne.

Key Responsibilities

• Developing global analytical strategies for assigned products aligned with program and corporate goals
• Provide scientific and regulatory guidance for analytical plans across all product development and LCM phasesDrive innovation in analytical technologies, platforms, and workflows
• Reviewing analytical study designs, reports, and regulatory documentation.
• Oversee development, validation, characterisation and implementation of analytical methods.
• Ensure high-quality data generation for product development and LCM programs.
• Troubleshoot complex scientific and technical challenges.
• Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GMP) and interface with regulatory agencies, responding to health authority queries.
• Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)
• Maintaining inspection readiness and quality standards.
• Partnering with internal stakeholders across Manufacturing, Quality Control, Quality Assurance, Research and external partners such as CROs/CDMOs, academic collaborators and technology vendors.

Your Profile

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience)
• Typically, 8+ years in bioanalysis within biotech, pharma, or CRO/CDMO environments
• Deep expertise in analytical development, product specification testing, characterisation, and data analysis.
• Demonstrated knowledge of regulatory requirements and analytical validation standards.
• Proven leadership and strategic program experience ideally in a global matrix environment.
• Experience supporting regulatory submissions and health authority interactions.
• Excellent communication skills including presenting complex information to non-scientific stakeholders.
• Experience with gene therapy products desirable, but not essential