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

Biopatrika; Ahmedabad District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Amneal Pharmaceuticals seeks a Deputy Manager / Manager, Analytical R&D E&L Inhalation in Ahmedabad, Gujarat. Lead API characterization using LC-MS/MS, GC-MS/MS, ICP-MS and manage extractables/leachables programs for inhalation products.

The role requires 8–10 years in pharma analytical development, strong scientific writing, and leadership abilities, with collaboration across formulation, device, packaging, quality, and regulatory teams.

Qualifications

• 8–10 years of experience in pharmaceutical analytical development.
• Hands-on experience with hyphenated techniques (LC-MS/MS, GC-MS/MS, ICP-MS).
• Strong writing, problem-solving and project leadership skills.

Responsibilities

• Lead API characterization activities using advanced analytical techniques.
• Design, execute, and interpret extractables and leachables studies for inhalation products.
• Perform toxicological risk assessments and establish analytical evaluation thresholds.
• Develop, validate, and troubleshoot analytical methods for impurities, degradants, E&L studies.
• Support regulatory submissions with technical reports and responses to queries.
• Coordinate cross-functional activities with formulation, device, packaging, quality, and regulatory teams.
• Review data for GMP/GDP compliance and drive continuous improvements in analytical capabilities.
• Mentor team members and provide technical leadership for complex investigations.

Skills

LC-MS/MS

GC-MS/MS

ICP-MS

Analytical method development

Education

M.Pharm / M.Sc. / Ph.D. in Analytical Chemistry or Pharmaceutical Sciences

Job description

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

Location: Ahmedabad, Gujarat, India

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 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.

Seniority levelMid-Senior level

Employment typeFull-time

Job functionResearch, Analyst, and Information Technology

IndustriesPharmaceutical Manufacturing

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