Analytical Research and Development

Coromandel International; Hyderabad; On-site; INR 1,200,000 - 1,700,000; Full time

Job summary

Coromandel International in India seeks a senior analytical chemist to lead method development, validation, and tech transfers for agrochemical products. You will develop stability-indicating methods using HPLC/UPLC/GC/LC-MS, troubleshoot OOS/OOT results, and draft robust compliance documents across USFDA/ICH/GLP standards.

You will mentor junior analysts, manage cross-functional R&D timelines, and ensure rigorous data integrity and documentation. NABL exposure is a plus.

Qualifications

• Advanced command over analytical hardware and data integrity (ALCOA+).
• Lead development, validation, and execution of methods for agrochemical products.
• Mentor junior analysts and oversee project timelines across R&D.
• Strong technical writing and cross-functional communication; project management helpful.

Responsibilities

• Lead design, optimization, and validation of stability-indicating methods.
• Troubleshoot chromatographic or instrumental issues and draft CAPA plans.
• Author, review, and approve validation protocols and SOPs.
• Coordinate method transfers to QC or manufacturing sites.
• Validate methods for AI, impurities, and storage stability.
• Ensure lab data meets OECD-GLP, CIPAC, SANTE guidelines.

Skills

Analytical method development

HPLC/UPLC/GC/LC-MS

Regulatory compliance

Team leadership

Technical writing

Education

M.S./M.Pharm in Analytical Chemistry

Tools

HPLC systems

GC/GC-MS systems

UV-Vis/NIR instruments

Mass spec software

Job description

Key Responsibilities:

• Method Development & Validation: Lead the design, optimization, and validation of stability-indicating analytical methods (HPLC, UPLC, GC, LC-MS, Dissolution) for drug substances or products or technicals.
• Troubleshooting & Investigation: Resolve complex chromatographic or instrumental issues, handle Out-Of-Specification (OOS) or Out-Of-Trend (OOT) results, and draft robust CAPA plans.
• Documentation & Compliance: Author, review, and approve critical technical documents, validation protocols, standard operating procedures (SOPs), and STPs in alignment with global regulatory standards (USFDA, ICH, GLP). Fair knowledge in NABL documentation and audits.
• Technology Transfer: Coordinate seamless method transfers to Quality Control (QC) or manufacturing plant sites.
• Validation & Verification: Validate methods for active content, impurity profiling, storage stability, and physical-chemical properties.
• Regulatory Compliance: Ensure all laboratory data aligns with OECD-GLP, CIPAC, SANTE, and country-specific registration guidelines (e.g., CIB&RC, EPA).
• Impurity Profiling: Identify and quantify unknown impurities, degradation products, and 5-batch analysis compounds.

Required Qualifications & Skills:

• Technical Mastery: Advanced command over analytical hardware/software (HPLC, GC, UV-Vis, FTIR, NIR, Dissolution, PSD, NMR, PXRD, Ion Chromatography, ICPMS, MS-MS, GCMS, LCMS, Prep-HPLC, UHPLC, AAS, Polarimeter, LAB analysis, Refractometer and other Wet lab analysis) and data integrity rules (ALCOA+).
• Domain Knowledge: Lead the development, validation, and execution of advanced analytical methods for agrochemical products. This includes active ingredients (AI), technical-grade materials, and diverse formulations (e.g., EC, SC, GR, WG). Ensure strict compliance with global chemical and agricultural data standards.
• Leadership & Mentoring: Guide, train, and oversee junior analysts and execution timelines across cross-functional R&D projects.
• Soft Skills: Strong technical writing, cross-functional communication, and project management skills (preferable but not essential).