Scientist-Chemistry-Analytical

Job Description:

Responsibilities

• Perform all activities in compliance with GxP requirements.
• Follow quality and safety requirements in accordance with organizational policies, procedures, and regulatory guidelines.
• Ensure technical outputs align with Global Training Curricula for instrument operation, material handling, and certifications related to Quality Operations, Manufacturing, and EHS.
•  Analytical Development and Troubleshooting
• Troubleshoot analytical issues related to methods and instrumentation.
• Develop and validate analytical methods using LC-MS, GCMS and ICP-MS for E&L work flow and Nitrosamine work flow support.
• Develop GTI impurity methods using LC-MS and GC-MS.
• Assess existing data packages, evaluate feasibility, and recommend remediation where needed.
• Has strong knowledge of USP, PQRI, and BPOG guidelines for SUS and MUS systems, along with expertise in writing non-laboratory, paper-based assessment reports for packaging commodities.
• Documentation, Governance, and Review
• Work with Quality Assurance and cross-functional teams to support consistent and disciplined execution of the LIR/ER/CAPA quality system, ensuring assigned tasks are complete and thorough.
• Maintain compliance with local and corporate procedures and keep all data packages audit-ready and transferable.
• Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making.

Qualification & Experience

• Qualification: Master's in chemistry/pharmacy/Ph.D
• Type of Experience: Brings 5–7 years of experience in Analytical Research and Development, with strong expertise in nitrosamine workflow support and extractables and leachable studies. Demonstrates hands-on proficiency in HPLC, GC, GCHS, and LCMS within GMP environments, supported by strong data interpretation and technical report-writing skills.