Deputy Manager / Manager, Analytical R&D E&L Inhalation

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Amneal Pharmaceuticals seeks an experienced analytical scientist to lead API characterization and EL studies for inhalation products and related components.

You will design and validate methods for impurities, degradants, and leachables, while supporting regulatory submissions and risk assessments. Strong leadership and writing skills are essential for cross-functional program success.

Qualifications

• M.Pharm /M.Sc./Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
• 8–10 years of experience in pharmaceutical analytical development.
• Hands-on with hyphenated techniques LC-MS/MS, GC-MS/MS, ICP-MS and regulatory requirements related to OINDPs.
• Strong scientific writing, problem-solving, and project leadership skills.

Responsibilities

• Lead API characterization activities using advanced analytical techniques such as LC-MS, GC-MS, ICP-MS, NMR, XRPD, DSC, TGA, and particle characterization tools.
• Design, execute, and interpret extractables and leachables studies for inhalation drug products, packaging systems, and device components.
• Perform toxicological risk assessments and establish analytical evaluation thresholds (AETs) in alignment with regulatory expectations.
• Develop, validate, and troubleshoot analytical methods for characterization of impurities, degradants, extractables, and leachables.
• Support regulatory submissions by preparing scientific justifications, technical reports, protocols, and responses to agency queries.
• Coordinate cross-functional activities with formulation, device, packaging, quality, and regulatory teams.
• Review data, ensure compliance with GMP, GDP, and internal quality standards, and drive continuous improvements in analytical capabilities.
• Mentor team members and provide technical leadership for complex analytical investigations.

Skills

Analytical chemistry

Regulatory compliance

Scientific writing

Project leadership

Education

M.Pharm

M.Sc.

Ph.D. in Analytical Chemistry

Tools

LC-MS/MS

GC-MS/MS

ICP-MS

Job description

Key Responsibilities:

• Lead API characterization activities using advanced analytical techniques such as LC-MS, GC-MS, ICP-MS, NMR, XRPD, DSC, TGA, and particle characterization tools.
• Design, execute, and interpret extractables and leachables studies for inhalation drug products, packaging systems, and device components.
• Perform toxicological risk assessments and establish analytical evaluation thresholds (AETs) in alignment with regulatory expectations.
• Develop, validate, and troubleshoot analytical methods for characterization of impurities, degradants, extractables, and leachables.
• Support regulatory submissions by preparing scientific justifications, technical reports, protocols, and responses to agency queries.
• Coordinate cross-functional activities with formulation, device, packaging, quality, and regulatory teams.
• Review data, ensure compliance with GMP, GDP, and internal quality standards, and drive continuous improvements in analytical capabilities.
• Mentor team members and provide technical leadership for complex analytical investigations.

Qualifications Experience:

• M. Pharm /M.Sc./Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
• 8-10 years of experience in pharmaceutical analytical development, with strong expertise in API characterization and inhalation EL studies.
• Hands-on experience with hyphenated techniques (LC-MS/MS, GC-MS/MS, ICP-MS) and regulatory requirements related to OINDPs.
• Strong scientific writing, problem-solving, and project leadership skills.