Overview In this role you will lead the development of generic inhaled dosage forms, from concept through lab-scale production and regulatory filing. You will drive pre-formulation, prototype development, and scale-up while applying QbD and ensuring timely project delivery. You collaborate cross-functionally to select materials, define formulation strategies, and compile technical and regulatory documents. This is an opportunity to shape inhaled product development within a collaborative, quality-focused environment.
Compensation / Benefits- base salary with range $90,000 - $115,000
- short-term incentive opportunity
- 401(k) matching
- comprehensive health and insurance benefits
- flexible benefits program
- career well-being initiatives
Responsibilities- Design and develop inhaled dosage forms (solutions, suspensions, gels, creams, ointments, sterile products) and oversee lab-scale manufacture
- Conduct literature reviews, pre-formulation studies, and prototype development
- Lead formulation strategies, material/package selections, and process scale-up to meet project goals
- Apply Quality by Design to DOE for robust formulations and processes
- Write technical reports, protocols, batch records, and project presentations
- Prepare ANDA submission documents including product formulas and manufacturing instructions
- Provide creative scientific solutions to complex problems and analyze data to propose action plans
- Coordinate with inter-department teams to ensure timely project execution
- Delegate tasks to and train junior scientists, providing guidance and supervision
Key requirements- 2 years or more of pharmaceutical development experience
- strong knowledge of inhaled dosage forms and regulatory documentation
- experience with lab-scale manufacturing and process scale-up
- ability to apply QbD principles in formulation design and experimentation
- excellent technical writing and data analysis skills
- team leadership and cross-functional collaboration experience
- leadership
- problem-solving
- strong communication
- inhalation dosage form development
- pre-formulation studies
- design of experiments (DOE)
