The Deputy Manager AR&D; will lead a team of scientists to develop, optimize, and validate robust analytical methods for APIs, advanced intermediates, and raw materials. This role acts as a bridge between synthetic R&D;, Quality Control (QC), and Regulatory Affairs, ensuring all analytical lifecycles strictly align with global regulatory frameworks (USFDA, EMA, PMDA) and cGMP guidelines.

Key Responsibilities

1. Analytical Method Development & Validation

- Lead the planning and execution of analytical method development (stability-indicating methods, assay, related substances, residual solvents) for generic and innovative API molecules.
- Oversee method validation and verification activities in compliance with current ICH guidelines ($Q2(R1)/Q2(R2)$).
- Drive complex impurity profiling, including the characterization and quantification of genotoxic impurities, nitrosamines, and elemental impurities.
- Implement Quality by Design (QbD) principles for analytical method development ($AQbD$).

2. Team Execution & Project Execution

- Supervise a team of junior managers, officers, and research scientists, ensuring proper resource allocation to meet strict project timelines.
- Troubleshoot complex instrument failures or analytical anomalies (e.g., peak splitting, baseline drift, matrix interference) encountered by the team.
- Guide the team through forced degradation studies (stress testing under acid, base, peroxide, thermal, and photolytic conditions) to prove method specificity.

3. Technology Transfer & Cross-Functional Collaboration

- Direct the smooth transfer of validated analytical methods from the AR&D; lab to the commercial manufacturing plant's Quality Control (QC)



department.
- Collaborate actively with Process R&D; (Synthetic Chemistry) to provide rapid analytical support and in-process testing for reaction monitoring.
- Work closely with the Regulatory Affairs (RA) team to prepare and compile chemistry, manufacturing, and controls (CMC) documentation for DMF/ASMF filings.

4. Quality Compliance & Documentation Review

- Review and approve analytical protocols, validation reports, Analytical Method Transfer (AMT) protocols, Standard Testing Procedures (STPs), and Standard Operating Procedures (SOPs).
- Investigate laboratory deviations, Out of Specification (OOS), and Out of Trend (OOT) results, implementing robust Corrective and Preventive Actions (CAPAs).
- Maintain the laboratory in a constant state of inspection readiness under Positive Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).

Technical & Instrumentation Expertise

Expected Hand-On / Review Expertise: Must possess deep technical knowledge of high-end analytical instrumentation data systems:

- Chromatography: HPLC, UHPLC, GC, Ion Chromatography (IC), Prep-HPLC.
- Hyphenated Techniques: LC-MS/MS, GC-MS.
- Spectroscopy & Solid-State Characterization: UV-Vis, FTIR, NMR, XRD, DSC, TGA.
- Software Environments: Empower 3, Chromeleon, LabSolutions.

Profile Requirements:

Education Ph.D. in Analytical Chemistry / M.Sc. in Organic or Analytical Chemistry / M.Pharm in Pharmaceutical Analysis.

Experience : 8 to 12 years of industrial experience in API AR&D.;

Core Skills : Data integrity driven, critical problem solver, technical report writing, and cross-functional project management.

📌 Deputy Manager - (Hyderabad)
🏢 Aurore Life Sciences
📍 Hyderabad