Associate Director, Analytical Strategy

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. /p 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). /p 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. /p 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. /p pThese positions have global reach and could be based at one either of our northern hemisphere sites (Bern, Marburg, King of Prussia or Waltham). /p h3Key Responsibilities /h3 pSpecific responsibilities for both these roles will include: /p ul lipDeveloping global analytical strategies for assigned products aligned with program and corporate goals /p /li lipProvide scientific and regulatory guidance for analytical plans across all product development and LCM phasesDrive innovation in analytical technologies, platforms, and workflows /p /li lipReviewing analytical study designs, reports, and regulatory documentation. /p /li lipOversee development, validation, characterisation and implementation of analytical methods. /p /li lipEnsure high-quality data generation for product development and LCM programs. /p /li lipTroubleshoot complex scientific and technical challenges. /p /li lipEnsure compliance with global regulatory guidelines (FDA, EMA, ICH, GMP) and interface with regulatory agencies, responding to health authority queries. /p /li lipLead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA) /p /li lipMaintaining inspection readiness and quality standards. /p /li lipPartnering with internal stakeholders across Manufacturing, Quality Control, Quality Assurance, Research and external partners such as CROs/CDMOs, academic collaborators and technology vendors. /p /li /ul h3Your Profile /h3 ul lipPhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience) /p /li lipTypically, 8+ years in bioanalysis within biotech, pharma, or CRO/CDMO environments /p /li lipDeep expertise in analytical development, product specification testing, characterisation, and data analysis. /p /li lipDemonstrated knowledge of regulatory requirements and analytical validation standards. /p /li lipProven leadership and strategic program experience ideally in a global matrix environment. /p /li lipExperience supporting regulatory submissions and health authority interactions. /p /li lipExcellent communication skills including presenting complex information to non-scientific stakeholders. /p /li lipExperience with gene therapy products desirable, but not essential /p /li /ul h3About CSL Behring /h3 pCSL 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. /p pCSL 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. /p pTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . /p h3Our Benefits /h3 pFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL ( . /p h3You Belong at CSL /h3 pAt 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. /p pTo learn more about inclusion and belonging visit /p h3Equal Opportunity Employer /h3 pCSL 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 pR- /p pCSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. /p #J-18808-Ljbffr