Associate Director, Analytical Strategy (m/w/x)

ph3Associate Director, Analytical Strategy (m/f/x) /h3pThe Associate Director, Analytical Strategy will lead the development and execution of analytical strategies to support biopharmaceutical development programs. This role /pprequires deep molecular knowledge, expertise in analytical testing and molecule characterization, and a strong understanding of Quality by Design (QbD) principles and /ppregulatory requirements. The successful candidate will drive analytical decision-making, ensure robust characterization of molecules, and support regulatory submissions /ppwith scientific rigor. /ph3Main Responsibilities Accountabilities /h3h3Strategic Leadership /h3ulliDevelop and lead the global analytical strategy aligned with program and corporate goals /liliProvide scientific and regulatory guidance for analytical plans across all development phases (discovery → post-marketing) /liliDrive innovation in analytical technologies, platforms, and workflows /liliRepresent analytical function in cross-functional governance and decision-making forums /li /ulh3Scientific Oversight /h3ulliOversee development, validation, and implementation of analytical methods (e.g., LC-MS/MS, ligand binding assays, biomarkers, immunogenicity) /liliEnsure high-quality data generation for PK, PD, biomarker, and immunogenicity studies /liliReview and approve analytical study designs, reports, and regulatory documentation /liliTroubleshoot complex scientific and technical challenges /li /ulh3Regulatory Compliance /h3ulliEnsure compliance with global regulatory guidelines (FDA, EMA, ICH, GLP, GCP) /liliLead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA) /liliInterface with regulatory agencies and respond to health authority queries /liliMaintain inspection readiness and quality standards /li /ulh3Cross-Functional Collaboration /h3ulliPartner with Clinical Pharmacology, DMPK, Toxicology, Biomarkers, and Clinical Operations /liliSupport translational strategy and dose selection decisions /liliManage external CROs, academic collaborators, and technology vendors /li /ulh3Leadership Management /h3ulliLead and mentor analytical scientists and project leaders /liliManage budgets, timelines, and resource allocation /liliBuild and scale analytical capabilities and infrastructure /li /ulh3Qualifications Experience Requirements /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 environments /liliDeep expertise in LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing /liliStrong knowledge of regulatory requirements and analytical validation standards /liliProven leadership and strategic program experience /liliExperience supporting regulatory submissions and health authority interactions /li /ulh3About CSL Behring /h3pCSL 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. /ppCSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. /ppTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . /ph3Our Benefits /h3pFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL . /ph3You Belong at CSL /h3pAt 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. /ppTo learn more about inclusion and belonging visit /ph3Equal Opportunity Employer /h3pCSL 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 . /p /p #J-18808-Ljbffr