Sr. Scientist

(JAN) YANJING JIANG

* ****** **** **., ********, NJ 07981

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

Cell: 732-***-****

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SUMMARY

Senior analytical expert in pharmaceutical research and development with 16 years experience in brand and generic companies.

* Demonstrated strength in leadership, planning, prioritization, decision-making and supervisory skills. Led, mentored, and managed team members to support formulation development and IND/IMPD, NDA and ANDA filings; maintained effective, transparent resource tracking and management for the assigned projects. Worked cross functionally with other departments, such as Reg CMC, QA and drug supply management.

* Demonstrated strong documentation skills, author for various drug substance and drug product GMP documents.

* Expertise in method development and trouble shooting. Experienced with most analytical instrument, such as HPLC, GC, LCMS etc. and lab software e.g. LIMS.

* Managed analytical outsource activities for drug substance and drug product.

* GMP document reviewer and QA certified GMP reviewer for clinical batch release.

* Team player, a go to person for HPLC software - Empower and Chromeleon, data management system - LIMS, and documentation system.

EXPERIENCE

Novartis Pharmaceutical Corp., East Hanover, NJ 2004 - Present

Pharmaceutical & Analytical Development /Analytical Research & Development

Senior Scientist

* Analytical Lead for the QbD pilot projects for the drug substance and drug product development.

* Participated in the timeline, workforce planning, and resources management for the projects. Participated and contributed in the technical research and development sub-team meetings and decision makings to support the clinical studies and IMPD/IND and NDA submissions. Answered health authority questions. Presented in the project review meeting for endorsement on the strategies or collecting feed backs from upper management.

* Communicated and collaborated with different line function groups e.g. drug supply management, QA and Reg. CMC to ensure successfully supply of drug products and documentations to the planned clinical trials.

* Designed technical, clinical and registration stability programs to define most suitable packaging configuration, storage and transportation conditions for the product. Identified degradation products pathway using LCMS to predict the potential degradation products and to better understand the chemical stability of the compound.

* Provided training and technical guidance to the team members to ensure the quality of work and timely completion of projects as required; Led team members to effectively perform routine sample analysis, troubleshooting, lab investigation, and clinical batch release.

* Expertise in method development and trouble shooting. Developed and validated drug substance and drug product methods using QbD strategy. Led Fishbone analysis and FMEAs for the late phase analytical methods and specifications for scientific peer review.

* Reviewed, analyzed and interpreted the analytical data to support drug product development, recommended formulation processing parameters, and proposed specifications with justifications. Participated in the formulation processing parameters fishbone analysis and FMEAs and provided input.

* Managed analytical outsourcing activities for drug substance and drug product, included activity planning, vendor selection and grant preparation. Instructed and reviewed outsourcing activities and documents.

* QA certified GMP reviewer for clinical batch release. Qualified GMP document reviewer for notebook, worksheet and other technical documents to ensure data integrity and compliance with company SOPs, USP/Ph Eur/JP, FDA/EMEA, and cGMP regulation.

* Strong documentation skills, author for DS/DP GMP documents, e.g. method, stability report, specification setting strategy document and CMC module document for IMPD/IND.

Ophthalmic Technical Development/Analytical Research and Development

Scientist

* Set up the new OTD lab with all different equipment needed for eye drops solution testing, e.g. HPLC, GC, FTIR;

* Configured Waters Empower Client/Server HPLC systems for the new lab;

* Conducted project training and Empower software training for peers;

* Supported research department for formulation development and NDA filing;

* Developed and validated test methods for Ophthalmic solutions using various instruments;

* Conducted routine analysis for ophthalmic solutions to establish shelf life.

West-ward Pharmaceutical Corp., Eatontown, NJ 1996- 2004

Analytical Research Lab

Supervisor

* Managed R&D staff to support various projects for oral solid dosage, communicated issues and solutions to senior management, answered health authority questions and supported ANDA filing.

* Recruited and trained R&D staff to ensure the quality of work and timely completion of projects as required.

* Prepared standard operating procedures for the R&D lab;

* Review analytical document to ensure data integrity and compliance with company SOPs, USP/Ph Eur, FDA, and cGMP regulation.

* Investigated OOE/OOS and deviations, wrote investigation/deviation documents.

* Evaluated analytical data generated, proposed specifications and prepared justifications.

* Instructed and reviewed the analytical work for the lab from parent company in Jordan;

* In charged of technology transfer to QC lab and parent company in Jordan;

Senior Chemist

* Troubleshoot the problem for existing methods and developed new methods for finished product.

* Validated new analytical methodologies and ensured compliance with FDA regulations.

* Conducted routine analysis for drug raw materials, in-process and solid dosage finished products using various instrument, following USP/in-house methods & cGMP/GLP requirements.

Arkansas State University, Chemistry Department

Teaching Assistant 08/1994 - 05/1996

In charge of Quantitative Analytical Chemistry and Organic Chemistry labs.

Research Assistant 01/1994 - 05/1996

Synthesized and characterized a number of organometallic compounds in order to model the catalyst/substrate interactions in the hydrodesulfurization process.

EDUCATION

Arkansas State University, Jonesboro, AR

Master of Science in Chemistry

Fujian Teacher’s University, Fujian, China

Bachelor of Science in Chemistry

SKILLS

Experienced with HPLC, GC, LCMS, FTIR, UV, KF, Dissolution, TPWII automation, viscometer, freezing point depression, Quality by Design, GMP, method development and validation, technology transfer, CMC module writing, health authority responses, people management, LIMS.

RECENT PUBLICATIONS

1. Identification of a drug degradation product found in a stressed dosage form using LC/MSn, LC/TOF MS and on-line H/D exchange MS. Changkang Pan, Yanjing Jiang, Hong Wen and Michael Motto. Journal of Pharmaceutical and Biomedical Analysis volume 57, 5 January 2012, pp. 99-103.

2. Reaction of CpRu(PPh3)2Cl with six-member cyclothioethers. Structures of the CpRu(PPh3)xL]Y complexes (L=pentamethylene sulfide, x=2, Y=BF4-; L=1,3-dithiane; 1,3,5-trithiane, x=2, Y=CF3SO3-; L=1,4-dithiane, x=1, Y=BF4-). Mark Green, M. Draganjac, Yanjing Jiang, Paul M. Nave, A.W. Cordes, C.D. Bryan, J.K. Dixon, S.L. Folkert, and C.H. Yu. Journal of Chemical Crystallography, Vol. 33, Nos. 5/6, June 2003.

3. Synthesis and molecular structure of [CpRu(1,4,7-S3C6H12)]O3SCF3. M. Green, M. Draganjac, Y. Jiang and A. W. Cordes. J. Cryst. Chem., 29, (1999) 273-276.

4. Molecular structure of [CpRu(PPh3)2(tht)]BF4, tht = C4H8S. Yanjing Jiang, M. Draganjac and A. W. Cordes. Journal of Chemical Crystallography, 26, (1996), 657-660.

5. Molecular structure of [CpRu(PPh3)2(C6H11SH)]BF4 CH2Cl2, Yanjing Jiang, M. Draganjac and A. W. Cordes. Journal of Chemical Crystallography, 25, (1995), 653-656.

PRESENTATIONS

1. The Utilization of LC-MS to Speed Excipient Compatibility Studies for Early Pharmaceutical Formulations. Yanjing Jiang, Kevin Bynum, Carl Allenspach, Erika Zannou, Tarun Patel

Pittcon, Chicago, IL, March 1, 2007.

2. TBBK in 2% Noviform eye ointment. Yanjing Jiang, Patrick Spence, Charles pan, Rao Mareppalli and Ferris Harmon. Chad/Phad seminar, East Hanover, NJ, Aug 2006.

3. The Reaction of CpRu(PPh3)2+ with Cyclothioethers. M. Draganjac, Mark Green, Yanjing Jiang, A. W. Cordes, C.D. Bryan, J. K. Dixon, S. L. Folkert and C. H. Yu. 210th National Meeting, Am. Chem. Soc., Chicago, IL, Aug. 20-24, 1995.

4. The Reaction of CpRu(PPh3)2+ with Cyclothioethers. Mark Green, M. Draganjac, Yanjing Jiang, A.W. Cordes, C. D. Bryan, J. K. Dixon, S. L. Folkert and C. H. Yu. 15th annual Undergraduate Chemistry Conference, University of Memphis, Memphis TN, March 11, 1995.

5. The Reaction of CpRu(PPh3)2+ with Cyclothioethers. M. Draganjac, Mark Green, Yanjing Jiang and A. W. Cordes. 78th Annual Arkansas Academy of Science Meeting, Jonesboro, AR, Apr. 8-9,1994.

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