Executive - Research and Development (Lab)

Job Description:

Job Summary:

We are seeking a skilled and detail-oriented Executive – R&D Lab with hands-on experience in GC-MS and GC-MS/MS analysis, specifically in Extractables & Leachables (E&L) studies. The candidate will be responsible for method development, validation, unknown identification, and ensuring compliance with regulatory and quality standards such as GLP and ISO.

Key Responsibilities:

• Perform GC-MS / GC-MS/MS analysis for VOC and SVOC profiling.

• Conduct Extractables & Leachables (E&L) studies as per regulatory guidelines.

• Analyze and quantify Nitrosamines, BPA, and other trace-level impurities.

• Develop, optimize, and validate analytical methods as per ICH / regulatory requirements.

• Perform data interpretation, spectral analysis, and unknown compound identification using libraries and advanced tools.

• Prepare and review analytical reports, documentation, and validation protocols.

• Ensure adherence to GLP, ISO, and regulatory audit compliance standards.

• Maintain laboratory instruments, calibration, and troubleshooting of GC-MS systems.

• Support internal and external audits with proper documentation and technical justifications.

• Collaborate with cross-functional teams for product development and regulatory submissions.

Qualification & Experience:

• Education: M.Sc. / B.Sc. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Chemistry, or related field.

• Experience: 2–5 years of relevant experience in GC-MS analysis, preferably in E&L studies.

• Hands-on experience in Nitrosamine analysis and trace-level impurity profiling is preferred.

Required Skills:

• Strong knowledge of chromatography and mass spectrometry principles.

• Expertise in method development and validation.

• Proficiency in spectral interpretation and unknown identification.

• Good documentation practices and audit handling exposure.

• Strong analytical and problem-solving skills.

• Attention to detail and ability to work in a regulated environment.