Job Title: Senior Scientist, Formulations
Location: Florida, Lupin USA Inc.
Function: R&D
Reports to: Director of Pharmaceutical Development
Summary
Independently conducts standard and advanced laboratory activities including evaluation and selection of raw materials, formulation development of Dry Powder Inhaler products following cGMP, Lupin EH&S and other relevant guidelines. Develops and evaluates new formulation technologies where required.
Essential Duties and Responsibilities
• Independently set up and operate laboratory equipment, conduct instrument and analytical method troubleshooting
• Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and perform statistical analysis.
• Write protocols, methods, standard operation procedures, and contribute to submission documents independently. Design experimental studies and write reports with minimal supervision.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers. Work and communicate effectively with other functional groups. Lead broad project tasks effectively, with minimal supervision.
• Independently conduct manufacturing activities for Dry Powder Inhaler drug products.
• Independently investigate and recommend corrective actions for Deviations, out-of-specification and out-of-trend results.
• Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good understanding of experimental design.
• Coach, train and support junior laboratory staff. Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; assure compliance to Lupin Quality procedures and follow Lupin safety rules and procedures. Comply with all Lupin Corporate guidelines and policies.
Qualification Requirements
• PhD in pharmaceutics or related discipline with 5+ years, MS with 10+years, or BS with a minimum of 15+ years formulation research experience in pharmaceutical or related field.
• Must possess expert knowledge of development and manufacturing of Dry Powder Inhaler products.
• Knowledge and in-depth understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Excellent understanding of USP methodologies and ICH guidelines.
• Strong English language skills including writing ability and oral communication. Experience with writing of CMC sections of regulatory documents (NDA, ANDA, IND).
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