Senior Scientist – Analytical Development

? Location: India, Mahārāshtra, Mumbai

? Industry: Personal Care Product Manufacturing

? Work Setting: Onsite

Are you passionate about advancing analytical science, solving complex chemistry challenges, and ensuring the safety and quality of consumer health products through cutting-edge analytical technologies? We are seeking a Senior Scientist – Analytical Development to lead analytical research, method development, impurity characterization, and lifecycle management activities supporting new product development and commercial products.

In this role, you will serve as a technical expert in analytical chemistry, utilizing advanced mass spectrometry and chromatography techniques to identify, quantify, and characterize trace-level impurities while supporting regulatory submissions, product quality, and global compliance requirements. You will collaborate with cross-functional teams across research, development, quality, manufacturing, and regulatory functions to deliver innovative analytical solutions.

Key Responsibilities

Analytical Method Development & Validation

- Develop, optimize, validate, and transfer analytical methods for the identification and quantification of trace-level impurities.
- Design robust analytical procedures supporting product development, commercialization, and lifecycle management activities.
- Lead method verification, validation, transfer, and troubleshooting efforts across internal and external laboratories.
- Ensure analytical methods meet applicable quality, regulatory, and compliance standards.

Advanced Mass Spectrometry & Trace Analysis

- Utilize advanced instrumentation including:
- LC-MS/MS
- GC-MS/MS
- ICP-MS
- Perform structural elucidation, impurity identification, and quantitative analysis at trace concentration levels.
- Investigate elemental impurities, residual solvents, extractables and leachables, nitrosamines, and other critical quality attributes.
- Provide scientific expertise in complex analytical investigations and problem-solving initiatives.

Product Development & Lifecycle Support

- Support analytical deliverables for new product development programs.
- Partner with formulation, process development, quality,



and manufacturing teams to address product and process challenges.
- Contribute to product investigations, reformulation efforts, and continuous improvement projects.
- Support product lifecycle management through analytical assessments and scientific evaluations.

Extractables, Leachables & Stability Studies

- Conduct extraction studies for packaging and container closure systems.
- Evaluate potential extractables and leachables risks and mitigation strategies.
- Support stability programs, degradation assessments, and shelf-life determination activities.
- Provide technical interpretation of study results and associated regulatory implications.

Laboratory Operations & Technical Excellence

- Operate and maintain sophisticated analytical instrumentation and laboratory systems.
- Serve as instrument owner and oversee qualification, calibration, maintenance, and performance monitoring activities.
- Ensure laboratory activities comply with GMP requirements, SOPs, and quality system expectations.
- Drive operational efficiency and continuous improvement initiatives within the laboratory environment.

Data Analysis & Scientific Reporting

- Review, interpret, and evaluate analytical data and trends.
- Prepare comprehensive technical reports, validation protocols, study summaries, and method documentation.
- Present scientific findings and recommendations to project teams and stakeholders.
- Ensure data integrity, documentation accuracy, and compliance with regulatory expectations.

Regulatory & Compliance Support

- Support regulatory submissions through generation of scientifically sound analytical data and documentation.
- Participate in internal audits, external inspections, and regulatory interactions as a subject matter expert.
- Ensure compliance with global regulatory requirements, industry standards, and quality management systems.




- Stay informed on evolving regulations, scientific guidance, and analytical technologies.

Project Leadership & Collaboration

- Independently manage analytical projects from planning through execution and completion.
- Lead analytical workstreams and provide scientific guidance on cross-functional project teams.
- Collaborate with global stakeholders to achieve project milestones and organizational objectives.
- Mentor junior scientists and contribute to technical capability development.

Innovation & Scientific Advancement

- Investigate emerging analytical technologies and methodologies.
- Drive innovation in impurity analysis, risk assessment, and analytical problem-solving.
- Recommend new approaches that improve analytical efficiency, quality, and scientific understanding.
- Contribute to knowledge-sharing initiatives and continuous scientific advancement.

Required Qualifications

- MSc, M.Pharm, B.Pharm, PhD, or equivalent degree in:
- Analytical Chemistry
- Pharmaceutical Sciences
- Chemistry
- Life Sciences
- Related scientific disciplines
- 7–12 years of experience in:
- Analytical Development
- Quality Control
- Pharmaceutical Research
- Consumer Health Products
- Nutraceuticals
- Food or Healthcare Industries
- Strong hands-on expertise with:
- ICP-MS
- LC-MS/MS
- GC-MS/MS
- Extensive experience in impurity identification, structural elucidation, and quantitative analysis.
- Proven experience in analytical method development, validation, optimization, and transfer.
- Solid understanding of GMP, quality systems, and regulatory requirements.
- Excellent analytical, scientific, and problem-solving skills.
- Strong written and verbal communication abilities.

Preferred Technical Skills

- Analytical Chemistry
- LC-MS/MS
- GC-MS/MS
- ICP-MS
- HPLC
- UPLC
- Gas Chromatography
- Ion Chromatography (IC)
- Atomic Absorption Spectroscopy (AAS)
- Extractables & Leachables Studies
- Elemental Impurities Analysis
- Nitrosamine Analysis
- Residual Solvent Testing
- Method Validation
- Method Transfer
- Structural Elucidation
- Stability Testing
- Regulatory Compliance
- GMP & Quality Systems
- Chromatographic Data Systems

📌 Senior Scientist – Analytical Development (Mumbai)
🏢 SoTalent
📍 Mumbai