1. Formulation design of oral, parenteral and topical product.
2. New drug delivery platform development for 505(b)2 candidate.
3. CMC preparation global submission.
4. Patent survey for new candidate and by-pass formulation design.
5. Trouble-shooting of existing commercial products.
• Perform functional assays for in-process and finished formulations in support of manufacturing and product release as well as stability study, including quantitative PCR assays, UV spectrophotometry, ELISA assays, or microbiological analysis.
• Receive general instructions on routine work, detailed instructions on new assignments.
• Provide scientific and technical expertise to support operations in Quality Control Department, including analytical method validations and technology transfer to other GMP sites.
• Improvise standard operating procedures and guidance for QC operations in compliance with GMP regulations.
• Document writing for method transfer, method validations, stability study report and investigations (Change control, Deviation and CAPA) as request.