Associate Director, Analytical Development at Sandoz

Job Description SummaryJob Description SummaryServes 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. Identifies areas of strength and improvement during due diligence and provides thorough documentation of the analysis.Job DescriptionSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path unique opportunities will present themselves both professionally and personally.Join us the future is ours to shape!Position Location:This position will be located at the Princeton NJ US Headquarters site.Our Sandoz flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely. This role will not have the ability to be located remotely. Preference will be given to local candidates not requiring relocation.Major Accountabilities / Your Key Responsibilities:Your responsibilities include but not limited to:Conduct thorough due diligence of products investigating the analytical method development validation tech transfer and specifications.Provide detailed gap and risk assessment of the reviews with mitigation/remediation plans.Deep understanding of analytical method development Nitrosamine impurities Extractable/Leachables data analysis methods and risk management procedures.Apply advanced scientific principles to solve complex analytical problems; propose innovative phase-appropriate solutions.Skilled scientist with expertise in trace level quantification of GTI/ Nitrosamines/Nitritesor similar impurities using LC-UV/FID Ion chromatography Mass Spectrometry LCMS MS-MS. Experienced using other laboratory instruments such as HPLC UPLC NMR GC UV Dissolution apparatus FTIR KF.Experience on dealing OOS/OOE and deviations involving above mentioned analytical techniques.Proficient with laboratory and/or technical knowledge of software and computer tools.Key Performance Indicators:Complete due diligence assessment within required timeline.Resolve complex analytical challenges on time and budgetAdherence to project milestones (submission approval launch) on timeKey Capabilities Required:-Generic Pharmaceutical Industry ExpertiseThorough understanding of the Generic drug development cycle and GMP requirements executing projects with heightened sense of urgency from kick-off to launch.-Complex Generic Product Development Expertise:In-depth understanding of the complex product development providing expert advice on analytical method development &validation issues leading root cause analysis and gaining alignment with cross functional teams.-Operational Excellence & Process Optimization:Expertise in streamlining workflows optimizing resource allocation and leveraging data-drivendecision-making to improve efficiency and scalability of launch processes.-Project & Portfolio Management Expertise:Deep understanding of project management methodologies and best practices to ensure seamlessexecution risk mitigation and on-time delivery.-Strategic Leadership & Vision:Ability to develop and execute high-level strategies for product launches aligning project goalswith overall business objectives while driving cross-functional collaboration.What youll bring to the role:Required Qualifications:Education & Experience:Bachelors and/or masters degree in a Chemistry discipline or related science disciplines 10 years of years relevant experience in analytical method development of small moleculesExperience in the Generics Pharmaceutical Industry (FDA requirements cGMPs) Experience with development and validation of Nitrosamine test methods Extractable and leachable or elemental impurities analysis and developmentShould have experience in due diligence strong analytical and research skills and the ability to handle confidential information.Hands on experience with one or more of the following: Sciex Triple Quadruple Mass Spec with Analyst software Xcalibur software Thermo Watson LIMS preferredPreferred Requirements:Ph.D. in a Chemistry disciplineProject Management ExperienceYoull Receive:Sandoz offers a generous employee benefits package that includes a competitive salary health insurance coverage for medical prescription drugs dental and vision a generous company match for retirement savings accounts and generous paid time off. We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility.The pay range for this position at commencement of employment is expected to be between $138600 -$254400 USD/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.On September 30 2021 Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations CIA-related deliverables and any relevant audit monitoring or Independent Review Organization (IRO) remediation. This role will have sub certifier responsibilities.Sandoz - Notice at Collection to Employees Applicants Why SandozGeneric and Biosimilar medicines are the backbone of the global medicines industry. Sandoz a leader in this sector provided more than 900 million patient treatments across 100 countries in 2024 and while we are proud of this achievement we have an ambition to do more!With investments in new development capabilities production sites new acquisitions and partnerships we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost high-quality medicines sustainably.Our momentum is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful flexible-hybrid careers where diversity is welcomed and where personal growth is supported!Join us!#SandozEEO 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.Accessibility and reasonable accommodationsSandoz Inc. is committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to or call 1- and let us know the nature of your request and your contact information. Please include the job requisition number in your message. </br>Salary Range$138600.00 - $257400.00Skills DesiredAdaptive Strategy And Innovation Clinical Research Cross-Functional Teams Drug Development Financial Management Interpersonal Communication Skills Microsoft Project Npd (New Product Development) Pmi (Project Management Institute) Pmp (Project Management Professional) Program Management Project Delivery Project Execution Project Life Cycle Project Planning R&D (Research And Development) Resource Allocation Risk Management Senior Management Stakeholder Management Time Management Skills Waterfall Project ManagementRequired Experience:Director Key Skills Fundraising,Management Experience,Biotechnology,Clinical Development,Clinical Trials,Research & Development,Training & Development,Grant Writing,Economic Development,Leadership Experience,Public Speaking,Product Development Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 138600 - 257400