Education & Experience
- PhD in Pharmaceutical Sciences or related discipline with 8+ years, MS with 12+years research experience in pharmaceutical or related field.
- Must possess expert knowledge in characterization of pressurized Metered Dose Inhaler (pMDI) and DPI products.
- Knowledge and in-depth understanding of global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
- Extensive knowledge of aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.) and analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.).
- 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 CMC sections of regulatory documents (NDA, ANDA, IND, IMPD).
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.
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