Sandoz US ยท 8 hours ago
Associate Director, Analytical Development
Princeton, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$139K/yr - $254K/yr
10+ years expSandoz is a global leader in sustainable Biosimilar and Generic medicines, undergoing a transformative period with unique professional opportunities. The Associate Director, Analytical Development will be responsible for conducting thorough due diligence of products, providing risk assessments, and applying advanced scientific principles to solve complex analytical problems.
Pharmaceuticals
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
Qualification
Required
Bachelor's and/or master's degree in a Chemistry discipline or related science disciplines
10+ years of 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
Ph.D. in a Chemistry discipline
Project Management Experience
Benefits
Health insurance coverage for medical, prescription drugs, dental and vision
A generous company match for retirement savings accounts
Generous paid time off
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Sandoz US
Sandoz is the global leader in generics and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients.
201-500 employees
H1B Sponsorship
Sandoz US 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
Growth StageCompany data provided by crunchbase