Associate Director, Analytical Development

Job summary Serves as the analytical expert for Sandoz, performing due diligence on potential business deals with partners. Reviews documentation—including analytical methods, method validation protocols, reports, specifications, Nitrosamines risk assessments, extractables/leachable, etc.—and provides detailed assessment to the project team. Responsibilities Conduct thorough due diligence of products investigating analytical method development, validation, tech transfer and specifications. Provide detailed gap and risk assessment of reviews with mitigation/remediation plans. Apply advanced scientific principles to solve complex analytical problems and propose innovative, phase‑appropriate solutions. Perform trace‑level quantification of impurities (GTI, Nitrosamines, Nitrites) using LC‑UV/FID, ion chromatography, mass spectrometry, LC‑MS, MS‑MS, and related instrumentation. Handle out‑of‑specifications, deviations, and quality issues involving analytical techniques. Use laboratory, technical, and software tools to support due‑diligence activities. Meet key performance indicators such as timely completion of assessments and adherence to project milestones. Key Capabilities Generic pharmaceutical industry expertise: deep understanding of the generic drug development cycle and GMP requirements. Complex product development expertise: advisory on analytical method development, validation, root‑cause analysis, and cross‑functional alignment. Operational excellence and process optimization: streamline workflows and enhance efficiency of launch processes. Project and portfolio management: apply best practices to ensure risk mitigation and on‑time delivery. Strategic leadership: develop and execute high‑level strategies for product launches aligned with business objectives. Required Qualifications Bachelor’s or master’s degree in Chemistry or a related science discipline. 10+ years’ experience in analytical method development for small molecules. Experience in the generics pharmaceutical industry, including FDA requirements and cGMPs. Experience developing and validating Nitrosamine test methods, and in extractable/leachable or elemental impurity analysis. Proficiency in due diligence, strong analytical and research skills, and handling confidential information. Hands‑on experience with one or more of the following: Sciex Triple Quadrupole Mass Spec with Analyst software, Xcalibur software, Thermo Watson LIMS. Preferred Requirements Ph.D. in a Chemistry discipline. Project management experience. Benefits Competitive salary (estimated $138,600 – $254,400 USD per year). Comprehensive health insurance (medical, prescription, dental, vision). Company match for retirement savings accounts. Paid time off and parental leave. Hybrid work policy: up to 50% remote work for US office‑based employees. Potential sign‑on bonus, restricted stock units, and discretionary awards. EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Sandoz, Inc. is committed to providing reasonable accommodations for individuals with disabilities. #J-18808-Ljbffr