Medical Quality Control

Yaohan Zheng

** ******** **. ************, ** ***44

908-***-**** (Home), 908-***-**** (Cell)

*******@*****.***

SUMMARY OF QUALIFICATIONS

Sixteen years in pharmaceutical industry with five years in medical writing

and 11 years in formulation development.

PROFESSIONAL EXPERIENCE

Medical Writer / QC Reviewer (Contract), Merck (Legacy Schering-Plough),

Clinical Research, Medical Communication, 5/2005-6/2010

. Prepare and quality review regulatory and safety documents: Clinical

Study Reports; Protocol and Protocol Amendments; Investigator

Brochures; Integrated Summary of Safety and Efficacy; Periodic Safety

Update Report; Annual Safety Report; Quarterly Safety Report;

. Projects cover Phases I-IV clinical studies.

. Therapeutic areas include Infections, Oncology, CNS, Cardiovascular,

Allergy, Women's health.

. Responsibilities include, but not limited to data accuracy, summary

and interpretation; document internal consistency; patient's safety

narratives; editorial and format review according to SOPs and

Guidelines.

. Update and quality control clinical study registry and results

disclosure.

Scientist, Pfizer Inc., Pharmaceutical R&D, 5/1997-5/2005

. Developed Phase I, II and commercial liquid and lyophile IV dosage

form

. Developed and optimized lyophilization cycle

. Evaluated packaging and filters for a parenteral product

. Wrote clinical dosage form nominations for phase I, II products and

various technical reports.

. Conducted pre-formulation studies

. Developed commercial dosage form for oral suspension

. Developed nominated clinical placebo of powder for oral suspension

Product and Process Development Chemist, Ben Venue Laboratories, Inc.,

7/1994--5/1997

. Developed generic parenteral products

. Developed & validated analytical methods

. Transferred manufacture and analytical technology

. Wrote documents for ANDA filing and deficiency letters

Research Assistant, College of Pharmacy, University of Cincinnati, 5/1992--

6/1994

. Developed and validated cation exchange HPLC assay of isoniazid and

its formulations using refractometric detection

. Developed and validated pre-column derivatization HPLC assay of

isoniazid and its formulations using variable UV-visible wavelength

detector

. Studied stability of isoniazid by using developed HPLC method

Pharmacist, Department of Pharmacy Service, Shanghai 1st People's

Hospital., 7/1986--9/1990

. Prepared and dispensed medications

. Manufactured parenteral and ophthalmic preparations

EDUCATION

M.S. Pharmaceutical Science. University of Cincinnati, College of Pharmacy,

June 1994

B.S. Pharmacy. Shanghai Medical University, College of Pharmacy, July 1986

PUBLICATION

H.S. Tan, J. Xu, Y. Zheng. Cation-exchange high-performance liquid

chromatographic assay of piperazine in some pharmaceutical formulations.

Journal of Chromatography A, 693 (1995) 307-314.

PRESENTATIONS

1. The Effect of Formulation pH on the Polymorphic Behavior of Mannitol

and Its Impact on Vial Breakage during Freeze Drying. Presenting at

2002 AAPS Annual Meeting, Toronto, Canada.

2. In Situ Crystal Form Conversion during the Manufacture of an Oral

Suspension. Presented at 2000 AAPS Annual Meeting, Indianapolis, IN.

3. Pre-Column Derivatization Reversed Phase HPLC Assay of Isoniazid (INH)

in Some Commercial Formulations Using UV-Visible Spectrophotometry.

Presented at 1994 AAPS Annual Meeting, San Diego, CA.

4. Cation Exchange HPLC Assay of Isoniazid (INH) in Some Formulations

Using Refractometric Detection. Presented at 1993 AAPS Annual Meeting,

Orlando, FL.

HONOR

University Graduate Scholarship. University of Cincinnati, Graduate School,

1992-1994

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