Sandoz · 1 month ago
Associate Director, Analytical Development
Princeton (Sandoz)
Full-time
Hybrid
Lead/Staff, Director/Executive
10+ years expSandoz is a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. The Associate Director, Analytical Development will serve as the analytical expert performing due diligence on potential business deals and providing thorough documentation of the analysis while identifying areas for improvement.
ManufacturingMedicalPharmaceutical
Responsibilities
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
Complete due diligence assessment within required timeline
Resolve complex analytical challenges on time and budget
Adherence to project milestones (submission, approval, launch) on time
Qualification
Required
Bachelor's and/or master's degree in a Chemistry discipline or related science disciplines Required
10+ years of years' relevant experience in analytical method development of small molecules Required
Experience in the Generics Pharmaceutical Industry (FDA requirements, cGMPs) is required
Experience with development and validation of Nitrosamine test methods required
Extractable and leachable or elemental impurities analysis and development Required
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
Ph.D. in a Chemistry discipline
Project Management Experience
Company
Sandoz
Sandoz is the global leader in generic and biosimilar medicines. Our Purpose is to pioneer access to medicines for patients globally.
10001+ employees
H1B Sponsorship
Sandoz has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (7)
2023 (6)
2022 (9)
2021 (11)
2020 (9)
Funding
Current Stage
Public CompanyTotal Funding
$3.61B2024-09-17Post Ipo Debt· $667.33M
2023-11-08Post Ipo Debt· $2.95B
2023-10-04IPO
Leadership Team
Meltem Korucu
CFO, Cluster TR&ME
Mohammed Obeidat, MBA
Vice President, CFO North America
Recent News
2025-12-08
2025-11-24
Company data provided by crunchbase