Quality Assurance Control

CURRICULUM VITAE

Dr. Lin Yang

Personal details

Address: ** ****** ******, ******** *****, Victoria 3156 Australia

Telephone: Home Phone: +61-3-8782-5862;Mobile Phone: +61-422-***-***

E-mail Address: *********@*****.***.**

Languages: English, Chinese (Mandarin),

Residency Status: Australian Citizen

Sex: Male

Career Objective

To work in a business environment, utilizing abilities developed through

work experience and education, with the opportunity for professional growth

based on performance.

Area of strength

Fast and accurate in acquiring new skills

Dedicated and diligent

Well developed interpersonal, written and oral communication skills

Very observant to ways of improving known techniques

Strong analytical, research, problem solving & project management skills

Exceptional work ethics and organizational skills

Able to meet objectives ahead of schedule

A keen eye for details & very good with numbers

Education and Training

Doctorate of Philosophy in Science Analytical Chemistry

Victoria University (VU), 2003

Bachelor of Science in Chemistry

Department of Pharmacy, School of Medicine, Peking University, CHINA,

1982

Career Summary

Date Role Employment history

Sep 2002 - May Method Development Arrow / Watson (Actavis)

2013 Chemist / Scientist III Laboratories Ltd

Mar 1995 - Aug Lab. Demonstrator / Victoria University

2002 Supervisor

Mar 2001 - Oct Instrumentation Victoria University

2001 Technician

Feb 1998 - July Scientist Food Science Australia

1998 (A Joint Venture of CSIRO and

AFISC)

Jan 1986 - Oct Research Scientist National Centre for Clinical

1991 Laboratory (NCCL), Beijing, CHINA

July 1982 - Jan Research Scientist Beijing Research Institute of

1986 Clinical Pharmacy, Beijing, CHINA

Professional History

Arrow / Watson (Actavis) Laboratories Ltd - Method Development Chemist /

Scientist III

September 2002 - May 2013

Duties:

11. Develop/validate analytical methods (including HPLC assay, impurity,

content uniformity and dissolution methods) and provide guidance on

method development and validation, stability and product release

testing activities in the lab to support the solid dosage

formulation development program.

12. Quick application of chromatographic knowledge to solve analytical

problems (including test results, test methods, and analytical

instruments, etc.) and performed QA testing on finished products and

raw materials to provide timely results to the formulation team.

13. Schedule and manage laboratory daily activities and control

laboratory inventories. Ensure project deadlines are met and

compliance with company policies and procedures and regulatory

requirements.

14. Write, review and approve various scientific documentations such

test method operating instructions and specification documentations,

protocols and reports for method investigation/method

validation/method transfer.

15. Perform method validation activities and review notebooks and

logbooks for completeness and compliance to support the stability

program.

16. Train and provide scientific and technical support to laboratory

scientists/chemists on laboratory safety, standard operation

procedures and instrument operation.

17. Communicate and follow-up with all relevant department and personnel

to move project forward smoothly.

18. Establish quality assurance system by creating, reviewing, and

approving standard operation procedures.

19. Dossiers compilations on products TGA (Australia) submissions.

Prepare and participate in TGA or FDA (USA) audit.

Victoria University - Lab. Demonstrator / Supervisor

March 1995 - October 2002

Duties:

20. Supervising and tutoring the students during study sessions and

examinations.

21. Demonstrating in practical classes in Inorganic Chemistry,

Analytical Chemistry, Organic Chemistry and Physical Chemistry.

Victoria University - Instrumentation Technician

March 2001 - October 2001

Duties:

22. Maintenance and troubleshooting of instrumentation including HPLC,

GC, GC-MS, AA and UV in the Analytical Laboratory.

Food Science Australia - Scientist

February 1998 - July 1998

Duties:

23. Development of the new foodstuffs high in fibre.

24. Development of the hydrolytic method of soluble fibre from insoluble

Lupin fibre.

25. Develop of a process (laboratory and industrial scale) that would

extract Lupin fibre from Lupin powder.

National Centre for Clinical Laboratory - Research Scientist

January 1986 - October 1991

Duties:

26. Maintaining and running laboratory in accordance with standard

operating procedures.

27. Designing and preparing experimental protocols.

28. Develop and validate HPLC methods for clinical therapeutic drugs in

urine, human saliva, tissues, and serum and plasma samples,

29. Establishment of clinical reference methods applicable in

determining the accuracy of clinical routine methods,

30. Monitoring and ensuring the quality control of laboratory data and

sample testing.

31. Performance of clinical routine analysis using HPLC and AA and

maintaining analytical instrumentation.

32. Training the laboratory staffs in HPLC methods and other modes of

analysis.

33. Monitor internal and external quality control and quality assurance

program of clinical laboratories nationwide by dispensing quality

control samples, analysing data and writing summary reports.

Beijing Research Institute of Clinical Pharmacy - Research Scientist

July 1982 - January 1986

Duties:

34. Maintenance of HPLC, GC and other laboratory equipment.

35. Development of clinical methods for the determination of drugs in

human plasma and serum.

36. Study of clinical pharmacokinetics and bioavailability of

therapeutic drugs in humans.

Professional Development and Competencies

Leadership skills, Team building & coaching, Assertiveness technique,

Effective Negotiation skills

Project Management, Problem Solving & Decision Making

Good knowledge and experience in chemical and biochemical analysis,

isolation, purification and characterization

Extensive experience in developing chromatographic methods from first

principles

Establishing analytical methods (including Column and Detectors selection)

and manipulation of HPLC, GC and GC-MS data and software

An intimate knowledge of columns selecting and changing, detectors using

and changing, and troubleshooting for HPLC, GC, and GC-MS

Expert in sampling of trace organic compounds (For GC-MS, including solvent

desorption tubes and thermal desorption tubes for different kind samples,

e.g. Charcoal, Tenax and XAD tubes)

Conducting pharmacokinetics investigations in humans

Knowledge of GLP/cGMP, TGA, FDA

Professional and Character referees

Furnish upon request

Publications

(Refereed papers and confidential reports)

1. Determination of Trace Elements In Human Tissues by High Performance

Liquid Chromatography of Metal-APDC Chelates. CLINICAL CHEMISTRY, Vol.36,

No. 6, 1990 969 U.S.A.

2. Simple and Rapid Determination of 5-Fluoro uracil (5-FU) in Human Plasma

by Reverse-phase High Performance Liquid Chromatography. Beijing Journal

of Clinical Pharmacology.

3. The Study of Clinical Pharmacokinetics and Bioavailability of

Praziquantel in injection and Tablets. Beijing Journal of Physiology

Science 7: (4), 1987 P.237

4. Matrix Effect on Jaffe's Reaction for the Determination of Serum

Creatinine. Chinese Journal of Medical Laboratory Technology 12: (1),

1989 P. 1

5. Simultaneous Determination of Uric Acid and Creatinine in Human Serum or

Plasma by Reverse-Phase High Performance Liquid Chromatography. Journal

of Liquid Chromatography 12: (10), 1989 P.1791 U.S.A.

6. Evaluation of Uric Acid Standard Solution Using Formaldehyde as

Preservative. Chinese Journal of Medical Laboratory Technology 12 (4),

1989 P. 199

7. Comparison Study on Several Commercially Available Reagent Kit of

Standard Solution of Uric Acid. Chinese Journal of Medical Laboratory

Technology 12 (5), 1989 P. 272

8. Sampling protocol for the analysis of organic compounds in the

Tullamarine Landfill gas. Cleanaway Technical Report. November, 1992.

9. GC-MS conditions for the separation of organic compounds in the

Tullamarine landfill gas. Cleanaway Technical Report. May, 1993.

10. Quantitation of organic compounds present in the Tullamarine landfill

site. Cleanaway Technical Report. July, 1993.

11. Cleanaway Tullamarine ambient air evaluation. Cleanaway Technical

Report. May, 1994.

12. Hydrocarbons in Landfill Gas: Sampling and Analysis. The Royal

Australian Chemical Institute's 10th National Convention Program Booklet

27 Sept. - 2 Oct. 1995 P. 70

13. Volatile Organic Compounds in Landfill Gas. The Royal Australian

Chemical Institute's Australian International Symposium on Analytical

Science 4 - 9 July 1999. P. 293

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