Requirements:
The Analytical Lab Scientist for Inhalation dosage forms will conduct and support analytical testing, method development, and validation activities for inhalation products. This role involves working in a GMP-compliant laboratory of pharmaceutical inhalation products.
Analytical Method Development and Validation:
• Develop, validate, and troubleshoot analytical methods for Inhalation dosage forms using Spray view, Spray tec, ADSA, Microscope, HPLC, GC, FTIR, UV-Vis, and particle size analysis techniques. • Perform method transfers and assist in the optimisation of existing methods.
Testing and Characterisation:
• Conduct testing for assay, related substances, particle size distribution, Spray pattern, plume geometry, and aerodynamic particle size distribution (APSD) using cascade impactors or laser diffraction. • Perform Drug product characterisation studies and stability testing for inhalation products.
Regulatory Compliance and Documentation:
• Ensure adherence to cGMP, ICH, and FDA regulatory guidelines in all analytical activities. • Prepare, review, and maintain documentation, including analytical protocols, reports, test methods, and SOPs. • Support regulatory submissions by providing analytical data and technical justifications.
Cross-Functional Collaboration:
• Work closely with formulation scientists, quality control teams, and manufacturing teams to support product development and execution.
• Participate in technical discussions and provide analytical insights for problem-solving and decision-making.
Preferred Skills:
Research and Continuous Improvement:
• Stay updated on advancements in analytical techniques and regulatory requirements for inhalation products. • Propose and implement innovative solutions to improve analytical processes and efficiencies.
Skills:
• Strong understanding of inhalation drug delivery systems and related analytical techniques. • Excellent troubleshooting and problem-solving abilities. • Familiarity with cGMP, FDA, and ICH guidelines. • Strong written and verbal communication skills.
Bachelor’s/ Master’s, in Chemistry, Pharmaceutical Sciences (B Pharm-M Pharm)
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.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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