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Project Manager Training

Location:
Apex, NC
Posted:
April 02, 2013

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Resume:

CATHERINE ZANG

New City NY *****

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

845-***-****

SUMMARY

With 8+ years of working experience at reputable pharmaceuticals, I have broad understanding of drug

development and manufacturing. I have the proven ability to direct new initiatives and lead special projects,

and I am familiar with FDA regulations, ICH guidelines and GMP policies.

PROFESSIONAL EXPERIENCE

RL COOPER & ASSOCIATES, New York, USA 2011-Present

Director of Business Development

Assist president and consultants with strategies to improve customer service and increase market share

• Implement strategies after market research, analysis, and strategic planning

• Recruit new clients through target networking approaches, and manage customer

relationships

• Increase service visibility through social media & advertisements

NOVARTIS PHARMACEUTICALS CORP., New York, USA 2007 – 2010

Sr. Scientist/Manager, Quality Assurance (QA) Department

Managed cross-site drug development projects with cross-functional teams to support drug manufacturing

• Coordinated with R&D, IT, QC, Stability and Compliance departments for method

development/transfers

• Developed and validated analytical methods with HPLC, UPLC, GC, KF, TLC

• Collaborated with Compliance Department for SOP and document reviewing, supported

NDA filling

• Trained other scientists on analytical methods

• Trouble-shot on technical issues, and provided solutions

• Wrote annual appraisals for employees

• Purchased office and lab supplies via ARIBA system or with vendors

• Attended corporate monthly meetings of strategic sourcing to improve the process and cut

costs

• Participated in laboratory audits and investigations

JOHNSON & JOHNSON, New Jersey, USA 2004 – 2005

R&D Analytical Chemist (contractor), Analytical & Chemical Development Department

Supported drug development R&D and regulatory submissions

• Performed stability analyses to support formulation screening, product release, clinical

trials

• Developed and validated analytical methods with HPLC/UV-VIS, PDA instruments

• Participated in laboratory audits and investigations

PURDUE PHARMA L.P., New York, USA 2001 – 2004

Scientist/Manager, Chemical Development Department

Managed multiple drug development projects to support kilo and pilot plant drug production

• Developed and validated analytical methods with HPLC/UV-VIS, PDA, GC and

LC/MS

• Purchased HPLC & GC instruments, columns and other lab supplies with vendors

• Evaluated instrument purchases and monitored vendor and CMO performances

• Reviewed batch records for product release

• Negotiated and signed contract agreements with Waters and Agilent Technologies for

PM Services

• Ensured employee safety and environmental compliance as a member of safety

committee

• Participated in laboratory audits and investigations

CATHERINE ZANG PAGE TWO

WYETH (PFIZER), Montreal, Canada 1999 – 2000

Analyst (contractor), Quality Control (QC) Department

Performed QC analyses (stability, assay, impurity, content uniformity and dissolution) with HPLC/UV-VIS,

GC instruments to support drug manufacturing

CANTONAL HOSPITAL OF GENEVA, Geneva, Switzerland 1992 – 1993

Chemist (professional training), Biochemical & Toxicology Department

Worked with doctors on drug influences on patients by using modern medical apparatus

TIANJIN MEDICINE UNIVERSITY HOSPITAL, Tianjin, China 1987 – 1992

Chemist/Supervisor, Biochemistry Department

• Worked with doctors on drug influences on patients to support CRO and clinical

trials

• Excelled in this position, which resulted in being transferred to Switzerland to learn

new technologies

EDUCATION

Pace University Lubin School of Business, New York, USA 2008-2012

MBA, Strategic Management and International Business (duel majors)

Université Laval, Quebec, Canada 1996-1998

MS, Food Science and Technology

Ecole Normale Supérieure & National Agriculture Institute, Paris, France 1993-1996

MS, Nutrition

Xiamen University, Xiamen, China 1983-1987

BS, Analytical Chemistry

AWARDS AND HONOR

Beta Gamma Sigma award

Member of Beta Gamma Sigma, the preeminent international honor society in business

COMPUTER AND INSTRUMENT PROFECIENCY

• Microsoft software: Excel, Word, PowerPoint, Outlook, Project

• Other software: Empower, Millennium 32 (4.0), ARIBA, LIMS, QDIS, SAP,TEDI

• Instruments: HPLC/UV-VIS, PDA, UPLC, GC, LC/MS, KF, TLC, Medical Devices

PROFESSIONAL MEMBERSHIPS ON LINKEDIN

Professionals in the Pharmaceutical and Biotech Industry Project Manager Network

Alliance Management and Business Development Network Pharmaceutical CRO, CMO

Directory

Business Strategy & Competitive Strategy Forum Strategic Sourcing &

Procurement

Corporate Planning & Global Industry Segmentation Global Business Development Center

ISO 31000 Risk Management Standard Quality and Regulatory Network

CATHERINE ZANG PAGE THREE

RELATED EXPERTISE

Novartis Pharmaceuticals Corporation, Suffern, NY 2008

Data and Records Management training

Novartis Pharmaceuticals Corporation, Suffern, NY 2008

Lean and process excellence training

Novartis Pharmaceuticals Corporation, Suffern, NY 2007

TEDI and Novstyle training

Novartis Pharmaceuticals Corporation, Suffern, NY 2007

ARIBA Software training

Novartis Pharmaceuticals Corporation, Suffern, NY 2007

Outlook software training

Johnson & Johnson, Skillman, NJ 2005

Seminar by SIELC Inc. on HPLC Columns: Reverse-Phase & Ion-Exchange

Johnson & Johnson, Skillman, NJ 2005

HPLC seminar by Phenomenex: Recent Development in Chromatography for Improved Separations

Waters Corporation, Princeton NJ 2004

Training on Millennium 32 Version 4.0 PDA

Johnson & Johnson, Skillman, NJ 2004

Training on Basics of Drug Active Handling

Johnson & Johnson, Skillman, NJ 2004

Seminar by Waters Co. on Intelligent Speed: Theory & Practice for Increasing Sample Throughput

Johnson & Johnson, Skillman, NJ 2004

Training: Application of GMPs to Analytical Laboratories

Training: Good Laboratory Practices (GLPs)

Johnson & Johnson, Skillman, NJ 2004

Training: GMPs for API Bulk Manufacturers

Johnson & Johnson, Skillman, NJ 2004

Training: How to Meet Drug Retention and Stability Testing

Johnson & Johnson, Skillman, NJ 2004

Training on Change Control

Johnson & Johnson, Skillman, NJ 2004

Training: Handling an FDA Inspection

Purdue Pharma L.P., Ardsley, NY 2003

Seminar by Agilent Technologies: Headspace GC Theory & Technology

CATHERINE ZANG PAGE FOUR

Purdue Pharma L.P., Ardsley, NY

2003

Empower software training by Waters Corporation

Princeton University, Princeton, NJ

2003

36th ACS Middle Atlantic Regional Meeting

Waters Corporation, Colorado Springs, CO

2003

2003 Waters Chromatography Data Symposium

Waters Corporation, Colorado Springs, CO

2003

FDA regulation course on 2003 Waters Chromatography Data Symposium

Purdue Pharma L.P., Ardsley, NY

2003

Excel training: Fundamentals, Intermediate, and Advanced

Purdue Pharma L.P., Ardsley, NY

2002

PowerPoint training: Fundamentals and Advanced

Purdue Pharma L.P., Ardsley, NY

2002

LC/MS seminar by Waters Co.: How to Develop LC/MS Compatible Methods;

Adaptation of Existing Methods to LC/MS

Purdue Pharma L.P., Ardsley, NY

2002

HPLC seminar by Agilent Technologies: Rapid Resolution Chromatography

Waters Corporation, Milford, MA

2002

HPLC Training: Practice Method Development & Validation for HPLC

Purdue Pharma L.P., Ardsley, NY

2002

HPLC seminar by Waters Corporation: Efficient Methods Development

Waters Corporation, Milford, MA

2002

LC/MS training: Alliance LC/MS System

Hewlett Packard, Agilent Technologies, Montreal, Canada

2000

HPLC seminar: pH and Choosing Column

Wyeth (Pfizer), Montreal, Canada

1999

Seminar by Isolation Technologies, Inc.: HPLC Connection Technologies

Wyeth (Pfizer), Montreal, Canada

1999

Training on Millennium 32 Version 2.0 UV-VIS

Hewlett Packard, Montreal, Canada

1999

Seminar on GC, GC/MS and LC/MS

National Agriculture Institute, Paris, France

1995

GC and MS training

Perkin Elmer, Paris, France

1994

GC training



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