Provided analytical supports for process development. Optimized process methods according to
the different residual solvents an d water content by using GC an d KF. Conducted solid state
screening of pharmaceuticals sample in non-GMP environments by utilizing X-ray, thermal
spectroscopic. Developed a robust an d reliable process method for potential potent API. Succeed in reducing the
certain impurity content by active carbon treatment an d crystallization. Drafted weekly Ｕpdates
and contributed to scientific an d technical discussions with co-workers an d clients.

Supported the RA department in general functions. Prepared label artwork mock-up for proposed
drug product according to RLD label an d FDA label safety considerations. Drafted cover letter
and CMC documents for ANDA submission an d other supplements like REMS an d PADER for
approved ANDA.
Created an d Ｕpdated Correspondence Index an d CMC Documents Index for the current
commercial product.

Developed stability-indicating methods for rectal gel based on USP monograph an d DMF.
Supported drug product development by applying robust analytical methods. Evaluated the
current HPLC method based on the specificity, accuracy an d precision an d altered test conditions
to achieve better separation. Performed regular maintenance for HPLC after each test.
Drafted specifications for known impurities based on ICH guidelines an d FDA recommendations.
Evaluated DMF technology package an d performed gap analysis for drug substance.
SME for IVRT （In Vitro Release Testing）. Setup system an d developed method for a topical drug
product by optimizing membrane, medium an d sample introduction. Compared both RLD an d the
generic drug product using the matrix method.