Job Title: Principal Scientist, Formulations
Location: Florida, Lupin USA Inc.
Function: R&D
Reports to: Director, Pharmaceutical Development
Summary
Supervise standard and advanced laboratory activities including evaluation and selection of raw materials and formulation development of Dry Powder Inhaler products following cGMP, Lupin EH&S and other relevant guidelines. Leads the development and evaluation of new formulation technologies where required. Initiates investigations and data reviews, plans formulation resource. Supervises, coaches and trains junior scientific staff.
Essential Duties and Responsibilities
• Supervise standard and advanced laboratory activities for the development of Dry Powder inhaler formulations following cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
• Write protocols, reports, methods and standard operation procedures
• Write regulatory submission modules and any other documents to support submission and product approval.
• Develop statistical design of experiments with minimal supervision.
• Independently design and develop manufacturing processes and conduct manufacturing activities for Dry Powder Inhaler products. Have good understanding of other inhalation technologies.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Provide expert support for manufacturing related technical issues.
• Develop and implement appropriate training programs for manufacturing activities across all respiratory development sites.
• 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 and across global respiratory R&D sites.
• Independently lead major project tasks.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Lupin safety rules and procedures.
• Comply with all Lupin Corporate guidelines and policies.
Qualification Requirements
• PhD in Pharmaceutical Sciences or related discipline with 8+ years, MS with 12+years 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 global regulatory requirements as applied to Respiratory or Nasal delivery. Good understanding of USP methodologies and ICH guidelines. Deep knowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry.
• Strong English language skills including writing ability and oral communication. Experience with writing of CMC sections of regulatory documents (NDA, ANDA, IND).
To apply, click here.
