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.

- Solid technical leadership, communication, and stakeholder management skills.

📌 Assistant Manager To Senior Manager - R&D (ADL) (Ahmedabad)
🏢 DISHMAN CARBOGEN AMCIS
📍 Ahmedabad