Principal Scientist, Synthetics Development AD Full-time

Principal Scientist

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 <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 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.

Required Skills:

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