Deputy Manager Manager Analytical RandD EandL Inhalation

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks an experienced analytical chemist to lead API characterization and inhalation E&L studies, develop and validate hyphenated methods, and support regulatory submissions.

You will mentor the team, ensure GMP/GDP compliance, and drive continuous improvement in analytical capabilities across formulation, device, and packaging programs.

Qualifications

• Advanced degree in analytical chemistry or pharmaceutical sciences.

Responsibilities

• Lead API characterization activities using advanced analytical techniques (LC-MS, GC-MS, ICP-MS, NMR, XRPD, DSC, TGA).
• Design, execute, and interpret extractables and leachables studies for inhalation products, packaging, and devices.
• Perform toxicological risk assessments and establish analytical evaluation thresholds (AETs).
• Develop, validate, and troubleshoot methods for impurities, degradants, extractables, and leachables.
• Support regulatory submissions with scientific justifications and technical reports.
• Coordinate cross-functional activities with formulation, device, packaging, quality, and regulatory teams.
• Review data for GMP/GDP compliance and drive continuous improvement.
• Mentor team members and provide technical leadership for complex investigations.

Skills

API characterization

LC-MS/MS

GC-MS/MS

ICP-MS

Inhalation E&L

Analytical method

Regulatory writing

Problem solving

Education

M.Pharm /M.Sc./Ph.D. in Analytical Chemistry

Tools

LC-MS/MS

GC-MS/MS

ICP-MS

Job description

Job Description:

Key Responsibilities

JOB DESCRIPTION

• 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 E&L 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.

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

• Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
• Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
• Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
• Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
• Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.