As a Technical Project Team Leader:• Lead technical project team comprising of formulation, analytical, chemistry, manufacturing, regulatory, QA functions located in multiple sites and time zones• Plan project strategy, budget and resources with inputs from all team members• Monitor project progress through regular communication with each team member • Ensure project issues are highlighted and addressed proactively• Form sub teams to resolve specific concerns, reach out to subject matter experts (SMEs) within and across sites and/or external consultants as required and facilitate timely resolution of issues• Collaborate with regulatory and other stakeholders within team to approach Center for Veterinary Medicine (CVM) at US-FDA to discuss relevant study designs and proposals e.g. biowaiver or bioequivalence, mixing or dilution study (for MFAs) early in development• Align with team members and stakeholders and facilitate decision making process • Communicate project progress, challenges, budgets and timelines and any changes promptly to management • Be accountable for timely completion of project goalsAs a Formulation Lead:• Single point of accountability for project activities within the dept.• Develop a stable, effective, robust formulation and process, leading to a technically sound CMC package• Plan formulation development strategy, conduct literature search, review and summary • Perform formulation activities and prepare reports for pre-formulation, lead formulation development, tech-transfer and registration batches and support to commercial site as required • Draft formulation manufacturing, sampling, packaging and stability protocols, SOPs for lab equipments/processes • Communicate project progress and issues/ risks proactively, contribute to risk assessment, problem solving and decision making process

Testing and documentation for antibiotic containing dry powder inhalers

Formulation development and documentation of immediate release oral dosage forms (tablets, capsules and dry syrups) for EU market