Training Maintenance

Danhui Sun

tel : 514-***-****

**** ****** **. ******, ** 20723

email: *********@*****.***

PROFILE

1. A highly productive analytical scientist with more than 15 years of

experience in the pharmaceutical industry.

2. Strong background knowledge and expertise in pharmaceutical property

evaluation, especially in the field of analytical chemistry and CMC.

3. Good organization and communication skill, and self-motivated team

player.

AREAS OF EXPERTIS

1. Application of routine analytical instruments (LC/MS, GC/MS and HPLC),

troubleshooting and maintenance.

2. Solid state characterization techniques using DSC, TGA, DVS, XRPD,

dissolution.

3. Design, validate and perform high-throughput screening using automated

robotic systems such as Tecan.

4. Pre-formulation, formulation development, salt form selection and IV

infuse assessment for drug candidate.

5. Chemical stability test.

CAREER HISTORY

2008. Oct -2013. Sep

Boehringer Ingelheim. Laval, Canada

Research Assistant II

Responsibilities:

1. High Throughput Screening assay of pharmaceutical properties such as

solubility and Log D.

2. Solid characterization for candidate compound (LC/MS, DSC, TGA, DVS,

XRPD, GLpKa for stability, hygroscopicity, crystallinity, solubility,

dissolution rate, pKa.).

3. Formulation design and salt form selection.

Major Achievements:

1. Efficiently learned and mastered the technical handling and

programming of Tecan robotic systems

2. Established high throughput screening platform for solubility and Log

D. Achieved a 4 times higher capacity and 2 times shorter cycle time.

3. Fully profiled for 8 drugs for further preclinical evaluation.

Completed CMC assessment for their further developbility.

4. Actively contributed to the lab and group meeting discussions and

monthly report writing on project related issues, particularly related

to CMC.

5. Delivered presentation to lab meeting and group discussions

2003. Feb -2008.Oct

Neurochem Inc. Laval, Canada

Neurochem Inc. is a pharmaceutical company based in Laval. It focuses on

the development and commercialization of innovative therapeutics for

Alzheimer's disease and Secondary Amyloidosis.

Analytical Chemist

Responsibilities:

1. Using, maintaining and troubleshooting HPLC, LC/MS and preparative

HPLC.

2. Using 18-Angles Light Scattering instrument to study amyloid peptide

and protein.

3. Conducting routine MS and HPLC analysis of chemical compounds and

peptides synthesized by the chemists (Exact mass of elemental

composition. Purity test by HPLC).

4. Performing DMPK study for our drug candidate (rat plasma and urine

analysis, Caco2 monolayer cell membrane, cell culture metabolism

analysis).

5. Developing method for separation of compounds.

6. Providing training and assistance to chemists for the use of Prep-

HPLC.

7. Using Dionex Ion-exchange chromatography to analyze the ionic

compounds or impurities (sulfate, bromide, succinic acid etc).

8. Applying size-exclusion chromatography to study amyloid peptide and

conjugated BSA.

9. Developing chiral separation method for drug candidate synthesized by

the chemists (using Regis Inc Pirkel type column and Daicel Inc. OD,

OJ and Crown-ether column).

Major Achievements:

1. In charge of all the instruments in chemistry department. Kept all the

instruments function well.

2. Succeeded in develop a new DMPK method, shorten the analyze time from

12 minutes to 5minutes.

3. Helped synthetic chemists purify theirs compounds. Meet the deadline

to submit the compounds. Training more than 10 chemists to use Prep-

HPLC and analytical HPLC

4. Finished a few hundreds of compounds analyses requested by synthetic

chemists (purity test, or method development for purifying by Prep-

HPLC).

5. Succeeded in method development of chiral separation for 3 groups of

important compounds

EDUCATION HISTORY

B.Sc, Biochemical Engineering

Zhe Jiang University, China 1990-1994

RELATED TRAININGS

Wyatt Inc 18 Angles Light Scattering training.

CMC Lab instrument training (DSC, TGA, DVS, XRPD, GLpKa)

Waters Inc Canada: Q-Tof Micro LC/MS Small Molecule Training .Agilent Inc

Canada: Agilent HPLC Maintenance and Troubleshooting .

Shimazu Co. Ltd Japan: Gas-Chromatography Application Training.

Lyophilizer: LyoStar 3

ANALYTICAL INSTRUMENT AND SOFTWARE

Mass spectrum: Waters Q-TOF micro MS and ZQ mass spectrum, Masslynx

HPLC: Waters Acquity UPLC/Empower . Agilent 1100 HPLC/Chemstation, Dionex

Ion-exchange chromatography/ Peaknet. GE AKTA Chromatography

system/Unicorn. Preparative HPLC:water 2795 Prep and Varian

Tecan Robot : Freedon evo, Evoware.

LANGUAGE

English --- excellent on reading, speaking and writing

French --- good at reading, basic at speaking and writing

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