Job ID: 7658
Job Title: Director Dry Powder Inhalation Formulation
Location: Baltimore, MD
Role Summary
Independently conducts standard and advanced laboratory activities including evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material etc.); pre-formulation and formulation development studies for solutions, suspensions, bulk and formulated powder and propellant based formulations for orally inhaled products following cGMP, Lupin EH&S and other relevant guidelines. Develops and evaluates new formulation technologies where required.
Essential Duties and Responsibilities
Independently design studies and conduct evaluation and selection of raw material (APIs, excipients, primary and secondary packaging material, device component material etc.).
- Independently design studies and conduct pre-formulation and formulation development studies for dry powder formulations and propellant driven formulations for metered dose inhalers (MDIs) including solutions, suspensions.
- Support manufacturing activities including powder blending, powder filling and troubleshoot technical issues during manufacture of Dry Powder Inhaler (DPI), Metered Dose Inhaler (MDI) and nebulizer drug products.
- Independently investigate and recommend corrective actions for deviations, out-of-specification and out-of-trend results.
- Independently set up and operate laboratory equipment, conduct instrument troubleshooting.
- Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and perform statistical analysis.
- Write protocols, methods, standard operation procedures, and contribute to submission documents independently. Design experimental studies and write reports with minimal supervision.
- 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. Lead broad project tasks effectively, with minimal supervision.
- Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good understanding of process technologies and experimental design.
- Coach, train and support junior laboratory staff. Establish and maintain effective relationships with team members.
- Conduct lab work in accordance with SOPs; assure compliance to Lupin Quality procedures and follow Lupin safety rules and procedures. Comply with all Lupin Corporate guidelines and policies.
- PhD in Pharmaceutics/Pharmaceutical Chemistry/Analytical Chemistry or related discipline with 5+ years, MS with 10+years, or BS with a minimum of 15+ years pre-formulation and formulation research experience in the pharmaceutical field.
- Must have hands-on experience with typical formulation and processing equipment. Experience with pre-DPI and MDI formulation development would be preferred.
- Knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Excellent understanding of USP methodologies and ICH guidelines.
- Strong English language skills including writing ability and oral communication.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in a laboratory environment.
