Associate Director, Analytical Development

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.

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.

• Complete due diligence assessment within required timeline.
• Resolve complex analytical challenges on time and budget
• Adherence to project milestones (submission, approval, launch) on time

-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.

• 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

• Ph.D. in a Chemistry discipline
• Project Management Experience

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 1/1/25 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…