Associate Director, Analytical Strategy

Descrizione del posto

Join CSL, a biotech leader advancing science in five therapeutic areas. You'll thrive in a collaborative environment with meaningful patient impacts. Tasks Design and oversee analytical strategies for product development. Ensure compliance with global regulatory guidelines and quality standards. Lead analytical sections of regulatory submissions and troubleshoot challenges. Skills PhD or MSc with extensive experience in analytical chemistry or related fields. Proven leadership in biotech or pharma with 8+ years of experience. Excellent communication skills for diverse stakeholder engagement. About the job 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 one either of our northern hemisphere sites (Bern, Marburg, King of Prussia or Waltham). Key Responsibilities Specific responsibilities for both these roles will include: 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 If you want to join a team that is working every day knowing that people’s lives depend on it, then apply now. Was wir bieten Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten . Über CSL Behring CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring . CSL soll so vielfältig sein wie die Welt, in der wir leben Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL. Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!