Job Description Summary
Job 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 Description
Sandoz 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/Nitrites or 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 tools. Good knowledge of software and computer tools.
Key Performance Indicators:
Complete due diligence assessment within required timeline.
Resolve complex analytical challenges on time and budget
Adherence to project milestones (submission, approval, launch) on time
Key Capabilities Required:
-Generic Pharmaceutical Industry Expertise
Thorough 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-driven
decision-making to improve efficiency and scalability of launch processes.
-Project & Portfolio Management Expertise:
Deep understanding of project management methodologies and best practices to ensure seamless
execution, risk mitigation, and on-time delivery.
-Strategic Leadership & Vision:
Ability to develop and execute high-level strategies for product launches, aligning project goals
with overall business objectives while driving cross-functional collaboration.
What you’ll bring to the role:
Required Qualifications:
Education & Experience:
Bachelor’s and/or master’s degree in a Chemistry discipline or related science disciplines
10+ years of years’ relevant experience in analytical method development of small molecules
Experience 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 development
Should 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 preferred
Preferred Requirements:
Ph.D. in a Chemistry discipline
Project Management Experience
You’ll 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 $138,600 -$254,400 USD/year; however, while salary ranges are effective from 1/1/26 through 12/31/26, 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 4.15.24[16].pdf
Why Sandoz?
Generic 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!
#Sandoz
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.
Accessibility and reasonable accommodations
Sandoz, 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 [email protected] or call 1-609-422-4098 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$144,800.00 - $268,800.00Skills Desired
Adaptive 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 ManagementTop Skills
What We Do
Sandoz is the global leader in generic and biosimilar medicines.
Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.
We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
