Principal Scientist, Synthetics Development AD

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Pharmaceutical Product R&D

Job Category:
People Leader

All Job Posting Locations:
Mumbai, Maharashtra, India

Job Description:

Position Title: Principal Scientist

Supervisor Title: Scientific Senior Director, Synthetics Analytical Development

Department Name: Analytical Development, TDS-Synthetics

Physical Location of Role: Mumbai, India

Position Summary:

We are seeking a highly skilled analytical scientist with expertise in Mass Spectrometry (MS) applications to support pharmaceutical analytical method development and testing activities.

The role will focus on supporting the development, optimization, validation, and troubleshooting of advanced analytical methods for Nitrosamines, Extractables & Leachables (E&L), and Elemental Impurities in compliance with global regulatory expectations.

Major Duties & Responsibilities:

Lead advanced analytical testing and investigation activities at the J&J IM R&D center in Mumbai and its associated CDMO's in India through scientific contributions, oversight, shop floor presence whenever needed for troubleshooting etc...



* Scientific lead in following analytical areas:

o Mass Spectrometry expertise (to oversee Nitrosamine testing- method development and investigations, organic impurity identification and structural elucidation, Extractable & Leachable).



* Support development, optimization, validation and transfer of analytical methods using Mass Spectrometry techniques for pharmaceutical products and materials.



* Knowledge and experience of working with Elemental impurities testing assessments via ICP MS (ICH Q3D, E&L), Particle Characterization and Morphology and NMR.



* Hands-on experience and expertise in handling analytical instruments like High Resolution and Low-Resolution Mass Spectroscopy (HRMS), LCMS/MS, GCMS/MS, ICP-MS, Laser Diffraction, Microscopy, NMR (Q_NMR)



* Interpret complex analytical data and prepare scientific protocols, reports, and regulatory documentation.



* Participate in laboratory investigations, troubleshooting, root cause analysis, and continuous improve...