Assistant Manager To Senior Manager - R&D (ADL)

Dishman Carbogen Amcis; Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Dishman Carbogen Amcis in Ahmedabad District, India, seeks an experienced Analytical R&D Lead to drive method development and validation for APIs and intermediates. You will lead HPLC/GC and spectroscopy work, ensuring ICH-compliant solvent analysis and regulatory readiness.

You will mentor analysts, coordinate with RA/QA/QC, and oversee GMP-compliant method validation, CAPA, and audits, contributing to continuous improvement within Analytical R&D.

Qualifications

• 7-15 years of experience in Analytical R&D, Method Development and Method Validation in API/pharma industries.
• Strong expertise in HPLC, GC, chromatography, spectroscopy and analytical troubleshooting.
• Solid knowledge of ICH guidelines, method validation, residual solvent analysis and regulatory requirements.
• Experience in audits, regulatory queries, deviations, lab incidents and compliance systems.
• Strong technical leadership, communication and stakeholder management skills.

Responsibilities

• Lead analytical method development for Raw Materials, IPCs, Intermediates and Finished Products using chemical, chromatographic and spectroscopic techniques.
• Review and approve analytical method validation, verification protocols, reports and supporting documentation.
• Collaborate with R&D, Regulatory Affairs, QA and QC to resolve analytical challenges.
• Develop and optimize methods for residual solvents, impurities and related substances per ICH guidelines.
• Provide expertise in chromatographic separation techniques and analytical troubleshooting.
• Prepare, review and implement SOPs for instruments, equipment and analytical procedures.
• Execute and supervise validation studies and reporting per GMP requirements.
• Act as primary contact during regulatory inspections, customer audits and external agency interactions on method validation and compliance.
• Investigate laboratory incidents, deviations and CAPA actions.

Skills

HPLC

GC

Chromatography

Spectroscopy

Analytical troubleshooting

Job description

Role & responsibilities

• Lead analytical method development activities for Raw Materials, IPCs, Intermediates, and Finished Products using chemical, chromatographic, and spectroscopic techniques.
• Review and approve analytical method validation, verification protocols, reports, and supporting documentation.
• Collaborate with R&D, Regulatory Affairs (RA), QA, and QC teams to resolve analytical and method-related challenges.
• Develop and optimize analytical methods for residual solvents, impurities, and related substances in accordance with ICH guidelines.
• Provide expertise in chromatographic separation techniques and analytical troubleshooting.
• Prepare, review, and implement SOPs for instruments, equipment, and analytical procedures.
• Execute and supervise analytical method validation studies and reporting activities as per GMP requirements.
• Act as a primary contact during regulatory inspections, customer audits, and interactions with external agencies regarding method validation and compliance.
• Investigate laboratory incidents, deviations, analytical issues, and ensure timely closure through appropriate CAPA actions.
• Mentor junior team members and drive continuous improvement initiatives within Analytical R&D.

Preferred candidate profile

• 7-15 years of experience in Analytical R&D, Method Development, and Method Validation within API or Pharmaceutical industries.
• Strong expertise in HPLC, GC, chromatography, spectroscopy, and analytical troubleshooting.
• Sound knowledge of ICH guidelines, method validation, residual solvent analysis, and regulatory requirements.
• Experience in handling audits, regulatory queries, deviations, laboratory incidents, and compliance systems.
• Strong technical leadership, communication, and stakeholder management skills.