Job Title: Fellow, Research
Location: Florida, Lupin USA Inc.
Function: R&D
Reports to: Senior Director, Inhalation R&D
Summary
Provides technical leadership in Research activities within Lupin Respiratory R&D Florida, functions as analytical and product characterization expert within Lupin globally.
Essential Duties and Responsibilities
• Supervise advanced laboratory activities in the following areas:
• Development of analytical methods for raw materials, in-process materials and finished pharmaceutical products
• Develop and use advanced methods to characterize and understand experimental dry powder formulations, including Laser Diffraction, BET surface area, DVS, DSC, SEM, etc.
• Development of LCMS and GCMS methods for impurity characterization, cleaning verification and leachable/extractable identification.
• Manage contract laboratories performing advanced analytical assays (XRD, microcalorimetry, spectroscopic methods)
• Function as a local expert in advanced analytical techniques, provide training and coaching to junior staff. Mentor and assist junior scientists
• Provide expert support for analytical and/or manufacturing related technical issues, analyzing data, identifying solutions, and implementing recommendations.
• Maintain expert knowledge in analytical technical issues by reviewing technical literature and journals and interacting with external experts in the field.
• Evaluate and introduce new technologies to improve productivity and efficiency; be capable of generating new practical ideas and apply broad knowledge of related disciplines; drive continuous process improvement.
• Design, develop and supervise the execution of method transfer protocols, development and validation of all analytical methods including excipients in drug products.
• Contribute as a subject matter expert to regulatory submission modules and any other documents to support submission and product approval.
• Provide expertise in statistical design of experiments. Coach junior staff and in general further the use of advanced statistical techniques.
• Perform structure elucidation on unknown impurities. Provide possible formation pathway for degradation impurities and recommend preventive solutions.
• Develop and implement appropriate training programs for analytical or 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.
• Lead internal/external projects on specific CMC topics within a team environment
• Contribute to innovative ideas and generation of innovative opportunities
• Influence decisions on CMC activities
• Establish and maintain effective relationships with team members.
• Follow cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
Qualification Requirements
• PhD in analytical chemistry, pharmaceutical sciences or related discipline with 11+ years research experience in pharmaceutical or related field.
• Expert knowledge of analytical techniques used for characterization of dry-powder based products including LC/GC/(MS), Laser Diffraction, Spectroscopic methods, powder density, Karl Fischer, BET, DVS, etc.
• Knowledge and understanding of global regulatory requirements as applied to Respiratory or Nasal delivery. Good understanding of USP methodologies and ICH guidelines. Extensive knowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry.
• Strong English language skills including writing ability and oral communication.
To apply, click here.
