Summary
Independently conducts, leads and supervises standard and advanced laboratory activities including evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for solids formulations including conventional and engineered dry powder inhalers (DPIs) following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines. Leads the development and evaluation of new formulation technologies where required. Initiates investigations, data reviews and coaches and trains junior scientific staff.
Essential Duties and Responsibilities
• Independently conduct, lead and supervise standard and advanced laboratory activities for the development of solids formulations including conventional and engineered dry powder inhalers (DPIs) formulations following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.
• Independently design and lead pre-formulation, formulation and process development studies to recommend selection of APIs, excipients, packaging material and manufacturing process.
• Independently design and develop manufacturing processes and conduct manufacturing activities for solid formulations including DPI products.
• Possess 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.
• 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.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with Transpire Bio and Transpire Bio partner companies’ team members.
• Work and communicate effectively with other functional groups and across global respiratory R&D sites.
• Independently lead major project tasks.
• Routinely provide feedback on the performance of junior staff to management.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Transpire Bio safety rules and procedures.
• Comply with all Transpire Bio Corporate guidelines and policies.
Qualification Requirements
• Ph.D., in Pharmaceutical Sciences, Pharmaceutics, Material Sciences, Chemistry, Chemical Engineering or related discipline with 6 to 12 years, MS with 12+years research experience in pharmaceutical or related field.
• Must possess expert knowledge of development and manufacturing of solid formulations including conventional and engineered DPI products.
• Knowledge and in-depth understanding of global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
• Must possess knowledge of manufacturing processes for solid formulations including conventional and engineered DPI products.
• Knowledge and in-depth understanding of global regulatory requirements as applied to formulation and process development.
• Excellent 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 chemistry, manufacturing and control (CMC) sections of US and EU regulatory documents (NDA, ANDA, IND, IMPD).
