Principal Scientist, Synthetics Development AD

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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 CDMOs 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 (QNMR)

• 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 (ADCs) 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 (CDMOs) in India.

Required Skills:

Preferred Skills: