Job Title: Scientist I, Pharmaceutical Development
Location: Florida, Lupin USA Inc.
Function: R&D
Reports to: Manager, Pharmaceutical Development
Summary
Conducts routine and non-routine laboratory activities following with minimal supervision. Assures that Quality standards are met. Prepares protocols and reports and documents activities following cGMP rules.
Essential Duties and Responsibilities:
• Conduct standard and advanced laboratory activities with minimal supervision including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
• Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
• Execute approved method transfer protocols, develop and validate cleaning validation methods
• Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and perform basic statistical calculations
• Write protocols, reports, methods, standard operation procedures, and submission documents with supervision
• Conduct manufacturing activities for MDI/DPI/Nasal drug products with limited supervision.
• Support the evaluation and introduction of new technologies
• Independently train other scientists
• 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 effectively with other functional groups. Lead small project tasks effectively, with some supervision.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Corporate safety rules and procedures.
• Comply with all Corporate guidelines and policies.
Qualification Requirements:
• PhD in analytical chemistry or related discipline with 0-2 years, MS in Chemistry with 3-5 years, or BS with a minimum of 7 years analytical research experience in pharmaceutical or related field.
• Must possess broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies and/or basic knowledge of development and manufacturing MDI/DPI/Nasal products.
• Knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH guidelines.
• Strong English language skills including writing ability and oral communication.
To apply, click here.
