Principal Scientist, Synthetics Development AD

Johnson Johnson; Mumbai; On-site; INR 3,000,000 - 4,200,000; Full time

Job summary

Johnson & J&J in Mumbai seeks a Principal Scientist with deep expertise in Mass Spectrometry to support the development and testing of Nitrosamines, E&L, and elemental impurities. The role focuses on method development, validation, and troubleshooting within a GxP environment.

You will lead MS applications, oversee transfer of analytical methods, and collaborate with R&D, Quality, Regulatory Affairs, and external labs to ensure regulatory compliance and data integrity across global projects.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related field.
• 7–8 years of related experience.
• Experience in a cGMP environment.
• Strong understanding of regulatory guidelines for Nitrosamines, E&L, and elemental impurities (ICH M7, USP <232>/<233>, etc.).
• Excellent communication and collaboration skills.

Responsibilities

• Lead MS-related analytical areas for Nitrosamine testing and E&L.
• Support development, optimization, validation and transfer of MS-based methods.
• Work with ICP-MS, Particle Characterization, Morphology and NMR in impurity assessments.
• Operate HRMS, LCMS/MS, GCMS/MS, ICP-MS, and related instruments.
• Prepare protocols, reports, and regulatory documentation.

Skills

Mass Spectrometry

Nitrosamines testing

ICP-MS

NMR

Method development

Regulatory compliance

Data interpretation

Education

Ph.D. in Analytical Chemistry

Tools

LCMS/MS

HRMS

ICP-MS

NMR

Job description

At Johnson & J&J, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & J&J is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & J&J, we respect the diversity and dignity of our employees and recognize their merit.

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

• Scientific lead in following analytical areas:
• 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 improvement initiatives.
• Collaborate with cross-functional teams including R&D, Quality Control, Regulatory Affairs, and external laboratories/vendors.
• Stay updated with emerging analytical technologies, regulatory trends, and industry best practices related to MS applications.
• Working experience in Oral Peptides and Antibody Drug Conjugates (ADC's) is an added advantage.

Required Qualifications

Required Minimum Education

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related scientific discipline

Required Years of Related Experience

7-8 years of related experience

Required Knowledge, Skills and Abilities

• In depth knowledge of API and DP development processes
• Regulatory guidelines and requirements in support of clinical studies and NDA/MAA filings
• Experience of working in cGMP environment
• Strong understanding of data interpretation, risk assessment, and analytical problem-solving.
• Familiarity with global regulatory guidance related to Nitrosamines, E&L, and elemental impurities (ICH M7, USP <232>/<233>, USP <1663>/<1664>, etc.).
• Excellent communication, technical writing, and collaboration skills.
• Exposure to packaging compatibility and toxicological risk assessment for E&L studies.
• Knowledge of software tools for MS data acquisition and interpretation.
• Ability to work in a fast-paced, cross-functional pharmaceutical R&D environment.

Travel on the Job

Yes

Percentage Traveled

30%

Type of Travel Required

Domestic andInternational

People Management Experience

Not mandatory

Required Years of People Management Experience

2 years

Key Working Relationships

Internal

• Team Leaders of other Mumbai Analytical Development sub-teams - direct colleagues, collaboration to ensure that similar practices and methodologies are employed for all compounds supported by the Higi ONE AD.
• Quality & Compliance - Partner with Quality function at Mumbai Analytical Development Center and Global Quality & Compliance partners.

Analytical Team in Belgium

Partnering and collaboration with team leads and colleagues from Belgium Analytical Development to ensure flawless transfer and execution from early phase to late phase development of our Synthetics portfolio.

External

Leadership of external contract organizations, External Contract Labs (ECLs), and Contract Development & Manufacturing Organizations (CDMO's) in India.

Preferred Skills

Budget Management, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Data Governance, Developing Others, Drug Discovery Development, Good Governance, Inclusive Leadership, Industry Analysis, Interdisciplinary Work, Leadership, Market Research, Process Improvements, Product Development, Product Strategies, Scientific Research, Stakeholder Engagement, Team Management