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Sr Associate Scientist/or Scientist
Member Number: 66693009
Mountain View, CA 94040
Portfolio: http://www.beyond.com/people/66693009
Professional Information
Job Function: Science & Biotech
Education: Some College
Experience: 10 – 15 Years
Employment: Any Position Type
Salary: $90k min.
Resume
*** ***
Analytical and Formulation Chemist
Home: ***; Cell: ***
SUMMARY
Highly motivated analytical and formulation chemist with extensive experience in the pharmaceutical industry.
Demonstrated expertise in drug substance and drug product analytical chemistry, formulation development and
preformulation in a cGMP and GLP environment. Developed, validated and wrote HPLC methods for drug substance,
drug products, trace impurity analysis and cleaning sample validation. Supported cGMP and GLP sample release and
stability testing.
TECHNICAL SKILLS
Developed and validated HPLC method, ELSD method using Empower software
Developed and validated dissolution method using USP apparatus I, II, IV and VII instruments
Prepared and wrote method, validation protocol and reports
Performed solid state characterization studies using polar light microscopy, Karl Fischer, DSC, TGA and DVS instruments
Conducted solution state preformulation studies using reverse or normal phase HPLC, dissolution and disintegration
instruments
Experienced in the handling of bioanalytical samples
Trained and experienced working in the GLPs and cGMPs environment with knowledge of USP and ICH guidelines
Provided accurate, written documentation of all lab work, including detailed observations and conclusions
Performed maintenance and troubleshooting of lab instruments
Multi-tasking and highly productive with high quality results
Sr Associate Scientist/or Scientist
Computer skills included: MS Word, Excel, ISIS draw, PowerPoint and Kaleidagraph
PROFESSIONAL EXPERIENCE
Allergan/MAP Pharmaceuticals
Aug, ***Present
SR. Professional/SR. Research Associate II
Developed impurities HPLC method for MAP*** project, prepared and wrote method and validation protocol. Conducted
Aerosol stability sample assay included impurity RRF determination, canister content test and impurity sample test for
GMP release and R& D study
Performed bubble screening study and leaking test for MAP*** canister products
Response all preformulation works for MAP*** and MAP***P*** projects such as solvents/pH solution solubility study, pH
solution stability study, suspension formulation development, hygroscopicity study and API dissolution method
development
Elixir Medical Corp.
***
Principal Scientist
Developed and validated ELSD method for impurities and degradation products in API and drug/device combination
products
Responsible preformulation work for analytical group such as impurities isolation/identification, solubility and stability
studies
Provide lot release for clinical trials, lot release for and after commercial release
testing such as product potency/content uniformity, drug related substances, drug in vitro elution, as well as drug/device
combination products. Write development reports, validations protocols and reports
Supported GC method development and GC sample assay for stent drug products
Supported dissolution method development using USP apparatus VII for stent drug products and conducted sample
release testing, as well as all stability sample assay
ROCHE PALO ALTO LLC,
Research Scientist I & Chemist III, Pharmaceutics Department
*** to ***
Performed physicochemical property characterization and formulation screening for lead compound selection; developed
and prepared formulations for toxicology and pharmacokinetic studies
Conducted solid state polymorph and salt selection
Performed stability studies for drug substances and drug products
Conducted drug and excipient compatibility studies
Determined solubility, pH-solubility profile, pH-stability profile, intrinsic dissolution, log P and log D measurements
Validated HPLC methods for drug substance and drug product analysis, release and stability testing for GMP samples
Supported cGMP cleaning method development, validation and sample analysis for the pharmaceutics department
Isolated and characterized trace impurities and degradation products
Developed and validated analytical methods for trace level impurities including azide analysis
Sr Associate Scientist/or Scientist
Wrote method validation protocol, cGMP method and reports, SOPs and preformulation reports
Chemist II & Chemist I, Analytical Department******
Carried out dissolution, disintegration and HPLC testing to support drug product registration of naproxen and other drug
candidates
Supported numerous projects for drug substance and drug product analysis and release
Performed dissolution, disintegration and HPLC method validation for many projects
EDUCATION
M.S. in Pharmaceutical Sciences, University of Southern California, Los Angeles, CA
Thesis: Pharmacokinetics of UFT, a Combined Formulation of Uracil and Ftorafur
B.S. in Pharmacy, Shenyang College of Pharmacy in China
PUBLICATIONS AND POSTERS
*** Chemical Stability of ***Azidocytidine and its Prodrug Balapiravir: Fujun. Li, *** ***, Xu Hadig, S. Huang, ***, T. Tran,
M. Brandl and T. Alfredson. Drug Development and Industrial Pharmacy, Vol. ***, Issue 4: ***, ***
*** Improving Absorption and Exposure of a BCS Class IV Compound with the Use of Crystallization Inhibitors and
Amorphous Systems: Karen Olocco, Dimitrios Stefanidis, Fujun Li, Li Li, Jin Wang, *** ***, Sujuan Huang, Paul Weller,
Tom Alfredson, Janet Gahagen, et al. Poster presentation at the AAPS annual meeting, Nov ***
*** Early Preclinical and Clinical Formulations of the HCV Replication Inhibitor Prodrug R***: M. Brandl, R. Birudaraj, X.
***, T. Tran, et al. Poster presentation at the AAPS annual meeting, Nov ***
*** Physicochemical Properties and Preclinical Data for the Selection of R*** Crystal form for Pharmaceutical
Development: M. Wong, F. Pang, J. Davidson, M. Lee, G. Zhornisky, X. ***, J. Kuo, et al. Poster presentation at the
AAPS annual meeting, Nov ***
*** Physicochemical Properties of the Nucleoside Prodrug R*** Leading to High Oral Bioavailability: Michael Brandl, ***
***, Marites Holper., et al. Drug Development and Industrial Pharmacy, Volume ***:***, ***
*** Chemical Reactivity of RO***, 1a-Fluoro***hydroxy***, ***E-diene***, ***bishomo***epi-cholecalciferol in Aqueous
Solution: Michael Brandl, *** ***, Yanzhou Liu, Joseph Pease; et al. J. Pharm. Sci., Volume ***: ***, ***
Sr Associate Scientist/or Scientist
*** Characterization of Polymorphs for RO***, A P*** MAP Kinase Inhibitor: Fujun Li and *** ***. Poster presentation at the
AAPS annual meeting, ***
*** Influence of Ferrous Sulfate on the Solubility, Partition Coefficient, and Stability of Mycophenolic Acid and the Ester
Mycophenolate Mofetil: Deborah Lidgate, Michael Brandl, Marites Holper, Allassan Abubakari, and *** ***. Drug
Development and Industrial Pharmacy, Vol. ***, Issue *** ***, ***