pCSL’s world-class RD 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. /pbr/pCSL is now seeking btwo /b bAssociate /b bDirector /b level scientists to design and oversee analytical strategies that support product development and lifecycle management (LCM). /pbr/pThe 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. /pbr/pThese 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. /pbr/pThese positions have global reach and could be based at one either of our northern hemisphere sites (Bern, Marburg, King of Prussia or Waltham). /pbr/h3Key Responsibilities /h3pSpecific responsibilities for both these roles will include: /pulliDeveloping global analytical strategies for assigned products aligned with program and corporate goals /liliProvide scientific and regulatory guidance for analytical plans across all product development and LCM phasesDrive innovation in analytical technologies, platforms, and workflows /liliReviewing analytical study designs, reports, and regulatory documentation. /liliOversee development, validation, characterisation and implementation of analytical methods. /liliEnsure high-quality data generation for product development and LCM programs. /liliTroubleshoot complex scientific and technical challenges. /liliEnsure compliance with global regulatory guidelines (FDA, EMA, ICH, GMP) and interface with regulatory agencies, responding to health authority queries. /liliLead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA) /liliMaintaining inspection readiness and quality standards. /liliPartnering with internal stakeholders across Manufacturing, Quality Control, Quality Assurance, Research and external partners such as CROs/CDMOs, academic collaborators and technology vendors. /li /ulbr/h3Your Profile /h3ulliPhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience) /liliTypically, 8+ years in bioanalysis within biotech, pharma, or CRO/CDMO environments /liliDeep expertise in analytical development, product specification testing, characterisation, and data analysis. /liliDemonstrated knowledge of regulatory requirements and analytical validation standards. /liliProven leadership and strategic program experience ideally in a global matrix environment. /liliExperience supporting regulatory submissions and health authority interactions. /liliExcellent communication skills including presenting complex information to non-scientific stakeholders. /liliExperience with gene therapy products desirable, but not essential /li /ulbr/ #J-18808-Ljbffr
Associate Director, Analytical Strategy Research Development & Sciences Discovery & Product Development CSL Behring Bern, Berne, Switzerland R-288583 Posted on October 7, 2026 Arbeitgeber: CSL Vifor
CSL Vifor ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern die Möglichkeit bietet, an bedeutenden technischen Projekten in einem dynamischen Umfeld zu arbeiten. Mit einem starken Fokus auf Inklusion und persönliches Wachstum fördert das Unternehmen eine Kultur der Zusammenarbeit und des Austauschs, während es gleichzeitig innovative Therapien für Patienten weltweit entwickelt. Die zentrale Lage in St. Gallen, Schweiz, ermöglicht den Mitarbeitern Zugang zu einer lebendigen Gemeinschaft und vielfältigen Freizeitmöglichkeiten.
