Principal Scientist, Synthetics Development AD

Biopharma Careers; Mumbai; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

Johnson & Johnson in Mumbai, India is seeking a Principal Scientist to lead advanced analytical method development and testing with a focus on Nitrosamines, E&L, and elemental impurities. You will oversee MS-based method development, validation, and tech transfer, collaborating with R&D, QA, and external labs to ensure regulatory readiness.

The role requires a Ph.D. in Analytical Chemistry or related field and 7–8 years of relevant experience in a cGMP environment, with strong data

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline.
• 7–8 years of related experience in pharmaceutical analytical development.
• Strong knowledge of API/DP development and regulatory expectations.
• Experience in cGMP environments and regulatory filings (NDA/MAA).
• Familiarity with regulatory guidance for Nitrosamines, E&L, and elemental impurities.

Responsibilities

• Lead advanced analytical testing and investigations in Mumbai and across CDMOs.
• Serve as scientific lead in MS-based Nitrosamine testing and impurity ID.
• Support method development, optimization, validation, and transfer using MS techniques.
• Work with ICP‑MS, E&L, and elemental impurity assessments; include NMR analyses.
• Interpret complex data, prepare protocols, reports and regulatory documentation.
• Collaborate with R&D, QA, Regulatory Affairs, and external labs/vendors.
• Stay current with analytical technologies and regulatory trends.

Skills

Mass Spectrometry

Nitrosamines testing

Regulatory knowledge

Analytical problem solving

cGMP experience

Communication & writing

Education

Ph.D. in Analytical Chemistry or related

Tools

HRMS

LCMS/MS

GCMS/MS

ICP‑MS

NMR

Laser Diffraction

Microscopy

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 & Johnson 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 & Johnson, 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

• 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: 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 / , USP / , 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 and International

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