API Chemical Research and Development Scientist, API Analytical Development Scientist in Ahmedabad, भारत

Job Description for API Chemical Research and Development Scientist

We are seeking a skilled and motivated Mid-Level Research Scientist to join our Active Pharmaceutical Ingredient (API) Process Research & Development team. In this role, you will design, optimize, and scale up safe, cost-effective, and robust chemical processes for drug substances. You will bridge the gap between discovery chemistry and pilot-plant scale production, ensuring all processes align with current regulatory and safety standards.

Key Responsibilities

• Route Scouting: Design and execute multi-step organic synthesis routes for generic APIs.

• Process Optimization: Optimize existing reaction parameters (yield, purity, throughput, and cost) using Quality by Design (QbD) principles.

• Scale-Up Support: Execute lab-scale validation batches and collaborate with engineering teams for tech transfer to the pilot plant.

• Analytical Characterization: Interpret complex analytical data from HPLC, GC, NMR, LC-MS, and Karl Fischer to monitor reactions and confirm structures.

• Documentation: Maintain accurate laboratory notebooks and draft tech transfer reports (TTRs) and standard operating procedures (SOPs).

• Safety & Compliance: Ensure all lab activities comply with cGMP guidelines, data integrity standards and EHS safety protocols.

Qualifications & Skills

• Education: M.Sc. or Ph.D. in Organic Chemistry, Medicinal Chemistry, or a closely related field.

• Experience: 4 to 7 years of industrial experience in API Process R&D (for M.Sc.) or 0 to 3 years (for Ph.D.).

• Technical Skills: Strong proficiency in retrosynthetic analysis, purification techniques (crystallization, distillation, chromatography).

• Software: Familiarity with SciFinder, Reaxys, Chemdraw.

• Core Competencies: Excellent problem-solving skills, strong teamwork, and clear technical communication skills.

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Job Requirements: Organic synthesis, Multi-step organic synthesis routes, Quality by Design (QbD), Process optimization, Scale-up support, Lab-scale validation batches, Tech transfer, Analytical characterization, HPLC, GC, NMR, LC-MS, Karl Fischer, Documentation, Laboratory notebooks, Tech transfer reports (TTRs), Standard operating procedures (SOPs), Safety & Compliance, cGMP guidelines, Data integrity, EHS safety protocols, Retrosynthetic analysis, Purification techniques, Crystallization, Distillation, Chromatography, SciFinder, Reaxys, Chemdraw, Problem-solving, Teamwork, Technical communication, Analytical method development, Stability-indicating analytical methods, Method validation, Validation protocols, Linearity, Accuracy, Precision, Specificity, LOD/LOQ, ICH Q2 guidelines, Instrument operation, Instrument calibration, Analytical instrument troubleshooting, UPLC, IC, Impurity profiling, Forced degradation studies, Structural elucidation tools, Genotoxic impurity identification, Analytical Method Transfer protocols, Quality Control (QC) manufacturing, Investigation, Analytical technical reports (ATRs), Out-of-specification (OOS) investigation, cGLP, FDA/EMA regulations, Pharmacopeia standards (USP/EP), Chromatography data software, Empower, ChemStation, Chromeleon, Technical troubleshooting, Analytical reasoning, Cross-functional communication