Associate Director, Analytical Development

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.

Job Dimensions:

Individual Contributor

What you'll bring to the role:

Required Qualifications:

Education & Experience (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 Requirements:

• Ph.D. in a Chemistry discipline

• Project Management Experience