Management Development

YIDE CHANG, Ph.D.

**** **** ***** ******, **********, NC 27858

Phone: 252-***-**** (M); Email: *********@*****.***

Objective

Looking for a position that leads and supports analytical development of

pharmaceutical products.

Career Summary

Ph.D. in Analytical Chemistry.

More than 12-year experience on management of Analytical Development in

pharmaceutical industry, including management of projects, laboratories

and department, and client services.

Expertise in method development and validation for pharmaceutical

products: HPLC(RP, NP, SEC, IEX, CE), GC, Ion Chromatography, LC-MS, GC-

MS, Dissolution, UV, Moisture, IR, Thermal Analysis, Particle size

analysis, Atomic adsorption, ICP-OES, ICP-MS, and etc.

Experience on analytical support for IND/NDA projects, including CMC

preparation.

Knowledge of ICH and FDA guidance, cGMP/GLP regulations and USP/EP

methodology.

Good communication and documentation skills.

Work Experience

March 2014 - Present Manager, Analytical Development, Xcelience

Inc. Tampa, FL.

Currently lead the department of analytical development from pre-

formulation, formulation support, analytical development, commercial

release test, to stability studies. There are ~30 chemists in the

department. The detailed responsibilities include:

. Lead, manage, and establish policies for the Analytical Development.

. Direct and manage capital expenditure and expense budget for

Analytical Development

. Provide technical direction and guidance to Analytical Development, as

necessary, in method development, validation, pharmacopeia, and

stability.

. Provide administrative management for Analytical Development

Department including performance reviews, accuracy of timesheets,

career development, disciplinary actions, participation of interviews,

and hiring replacement or additional resources.

. Work with and provide necessary support and project status update to

other groups and departments to ensure successful and timely

completion of projects.

. Maintain a positive, professional, and confidential relationship with

existing and potential clients. Participate in meetings and on-site

visits with existing and potential clients

. Ensure compliance with internal SOPs, cGMP, and State /Federal

regulatory requirements.

. Review/approve/oversee SOPs, Deviations, CAPAs, OOS/OOT

investigations, Change Controls, Protocols/Reports, and Analytical

Methods.

. Provide support to Contract Management in a timely manner

. Provide technical advices to Management Team on specific project

candidates and make recommendations to Management Team on future

strategic growth area and capacities.

May 2002 - Mar 2014 Senior Manager, Analytical Services

Metrics Inc. Greenville, NC

Responsibilities include:

. Leading a team of ~20 analytical chemists and directing analytical

support for pharmaceutical product development from pre-formulation to

finished products.

. Communicating with clients for project management and representing

analytical support to attend technical/managerial meetings.

. Reviewing or approving methods for drug substance and drug products,

validation protocols and reports, analytical reports, certificates of

analysis, OOS/OOT/deviations and stability reports for IND, NDA, or

ANDA projects.

. Supervising characterization of drug substances, release of API and

finished products, and stability study of finished products.

. Instructing scientists on the development and validation of HPLC,

LC/MS, GC, GC/MS, Ion chromatography, dissolution, UV, IR, elemental

impurities, and moisture methods.

. Leading and supervising scientists on other works supporting

formulation development.

. Establishing the capacity of Ion Chromatography, LC/MS, GC/MS, and ICP-

MS for company; leading projects on Ion Chromatography, LC-MS, GC-MS,

Elemental Impurities and Particle size Analysis companywide.

. Appraising performance of group leaders and lab supervisors; rewarding

and disciplining employees. Mentoring employees on career development.

Recruiting/Hire new employees.

. Reviewing/approving SOPs and DQ/IQ/OQ/PQ for instrumentation.

. Helping business department to recruit projects. Helping management on

monthly revenue and cost planning.

. Working on Evaluation and Acquisition of new Laboratory

Instrumentation: HPLC, GC, LC/MS, GC/MS, IC, Particle size analyzers,

ICP-MS, Dissolution units, and etc.

May 2001 - Apr. 2002 Scientist Schering-Plough Research Institute,

New Jersey

Responsibilities include:

. Developed and validated HPLC and dissolution methods for

pharmaceutical products

. Designed and performed the stability study

. Prepared the monographs of products and technical reports

June 1999- May 2001 Scientist

Department of the Formulation & Process Development, Wyeth Vaccines,

Pearl River, NY

Responsibilities:

. Developed and validated analytical methods for protein, polysaccharide

and protein-polysaccharide conjugate assay in vaccines at research,

development and production stages using HPLC, ELISA, Western Blotting,

electrophoresis and UV spectroscopy.

. Performed studies of the characterization, stability study and

degradation of penumococcal polysaccharides and their protein

conjugates.

Educations

Louisiana State University and A&M College Baton Rouge, LA, USA

1992-1998

Ph. D in Analytical Chemistry

Jilin University, Changchun, China 1984-

1987

M. S. in Physical Chemistry

Zhengzhou University, Zhengzhou, China 1980-

1984

B. S. in Chemistry

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