Walk-in | ADL - Officer / Executive

BDR Pharmaceuticals; Panchmahal District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

BDR Pharmaceuticals in India seeks an ADL Analyst to drive advanced analytical method development and characterization for complex dosage forms, including injectables and peptides, while addressing regulatory inquiries globally.

The role involves method optimization, technology transfer support, and ensuring adherence to ICH and cGMP standards, with hands-on work on HPLC, GC, UV, and dissolution equipment, plus thorough documentation.

Responsibilities

• Perform method development, optimization, and troubleshooting for injectables, lyophilized formulations, depot formulations, peptides, and OSDs.
• Conduct advanced characterization using DSC, XRD, NMR, IC, ICP-OES.
• Lead or support transfer of analytical methods from R&D/ADL to QC labs or manufacturing sites.
• Prepare and review Tech Transfer Protocols (TTP) and reports.
• Coordinate with cross-functional teams (R&D, QA, QC, Production).
• Perform method validation, verification, and troubleshooting.
• Ensure methods comply with regulatory standards like ICH guidelines.
• Handle instruments like HPLC, GC, UV, dissolution apparatus.
• Write SOPs, protocols, reports, and risk assessments.
• Ensure compliance with cGMP and regulatory requirements; support audits and inspections.

Job description

ADL - Query and Characterization

To perform advanced analytical method development and characterization for complex dosage forms (injectable, lyophilized products, depots, peptides, and oral solids), and to effectively handle regulatory queries from global markets in compliance with international guidelines.

• Perform method development, optimization, and troubleshooting for:
  • Injectables, lyophilized formulations, depot formulations, peptides, and OSDs
• Conduct advanced characterization using instruments such as:
  • DSC (Differential Scanning Calorimetry)
  • XRD (X-ray Diffraction)
  • NMR (Nuclear Magnetic Resonance)
  • IC (Ion Chromatography)
  • ICP-OES (Inductively Coupled Plasma Optical Emission Spectroscopy)

ADL - Documentation Review

• Responsible for preparation and reviewing of Specification, Method of analysis,raw material, in process, finished product and other documents.
• Responsibility of preparing & reviewing vendor qualification & Tech Transfer documents.
• Responsibility of maintaining Analytical Documents & records.
• Responsible for preparation of study reports, nitrosamine, elemental, residual solvent,genotoxic .
• Daily and monthly calibration of instrument.
• Responsible for maintaining analytical chemicals, solvents, analytical standard and chromatographic columns within the laboratory.

ADL - MS&T

Technology Transfer

• Lead or support transfer of analytical methods from R&D/ADL to QC labs or manufacturing sites
• Prepare and review Tech Transfer Protocols (TTP) and reports
• Coordinate with cross-functional teams (R&D, QA, QC, Production)

2. Analytical Method Support

• Perform method validation, verification, and troubleshooting
• Ensure methods comply with regulatory standards like ICH guidelines
• Handle instruments like HPLC, GC, UV, dissolution apparatus

3. Documentation & Compliance

• Write SOPs, protocols, reports, and risk assessments
• Ensure compliance with cGMP and regulatory requirements

Support audits and inspections