A fast-growing generics company based in New Jersey is seeking a Principal Scientist to serve as the site’s inhalation product development Subject Matter Expert. Background should be in generics. Effectively a director-level role, as it reports directly to the Vice President. However, the role also involves bench work alongside the administrative and mentorship responsibilities. Requires 30% international travel.
The Principal Scientist, Inhalation Product Development fulfills a critical role in supporting the development of dry powder and metered dose inhaler Inhalation products.
As a part of the Inhalation Development team, the individual is involved in formulation and process development, in-vitro bioequivalence studies, characterization of active ingredients and excipients, evaluation and selection of container closure systems, manufacturing and analysis of exhibit and stability batches, and product characterization studies.
- Execute scientific experiments to develop robust formulation and processes for the company’s inhalation projects.
- Provide technical and project leadership to inhalation projects while being an individual contributor in consistent, creative and innovative manner.
- Conduct manufacturing process development and technology transfer to ensure processes and related operating procedures are successfully developed and seamlessly transferred in to commercial production. Develop strategies for process scale-up and execute process validation.
- Engage in formulation analysis and conduct product characterization studies and analytical aerosol testing. Strong background in in-vitro bioequivalence studies is required.
- Compile results from all development studies in scientific reports. Contribute to the compilation of the relevant CMC sections for regulatory filing.
M.S. or Ph.D. w/ 7-10 years of relevant industrial experience in inhalation generics.
Need 6 years or more:
- Inhalation product development
- Experience with Drug delivery devices/combination products.
- Need 8 years or more, or Ph. D. with 6-8 years inhalation product development experience with associated inhaled product analytical testing:
- Strong knowledge of formulation and manufacturing sciences (product development, process research, scale-up and technology transfer) in Inhalation (single/multiple dose DPIs and MDIs, dose counters and human factor assessments acquired through academic training plus on-the-job experience)
- Experience in MDI and DPI formulation, manufacturing and testing is required.
- Experience in final dosage formulation
- Experience in analytical testing of DPIs and MDIs, including in vitro BE studies, is expected
- Ability to interact effectively with management and others in group, project teams and personnel at manufacturing sites and CMOs.
- Ability to manage multiple and complex projects.
- Superior written and oral communication skills.
- Team player with strong interpersonal skills able to work in networks across cultures and geographies
- Prepared to travel internationally (30%)