Process Development

MELISSA CHAU

**** **** **** ****** *****: 718-***-****

Brooklyn, NY 11229 *******@*****.*** Cell: 646-***-****

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SUMMARY

Process Chemist with 15+ years of experience in process development and

synthetic chemistry. Experienced in technical writing of process

development from lab to plant scale-up activities, and in analyzing and

evaluating experimental data such as UV, NMR, GC and HPLC. Trained in cGMP

and OSHA regulations. Knowledge of U.S. and ICH regulatory guidance's and

the ability to assure compliance with the regulations. Excellent knowledge

of ICH, GCP, FDA, TPD and EMEA. Proficient in CambridgeSoft ELN, Symyx ELN

and in Microsoft Excel, PowerPoint, Word, Adobe Acrobat, PDLIMS, SAP, and

Chemdraw. Perform literature searches using ISIS Base and REACCS, PCRIS

and SciFinder.

PROFESSIONAL EXPERIENCE

Process Chemist, Process Research Department June

2009 - March 2010

MERCK &CO. Rahway, NJ

. Working in the prep lab, scaled up syntheses from gram to kilogram scale

to provide intermediates that impacted several discovery programs.

. Regulatory compliance to meet SOPs, EHS and cCMP guidelines in synthesis

of API for toxicity studies and clinical supplies.

. Optimized reaction conditions where possible.

. Utilized NMR, HPLC, MS for structure/purity determination.

. Used ISCO purification systems to improve quality of product.

Associate Research Scientist II, Process Research & Development

1993 -2008

BRISTOL-MYERS SQUIBB, New Brunswick,

NJ

. Collaborated with international outsourcing vendors and Tech Ops

colleagues to demonstrate cGMP and LTSS campaigns both internally and in

BMS site in Swords, Ireland.

. Developed glass plant and pilot plant processes for toxicity studies and

clinical supplies.

. Designed and conducted laboratory procedures and optimized protocols to

achieve high quality product and yields.

. Reviewed and witnessed laboratory notebook, batch records and log sheets

to assure compliance with cGMP's.

. Prepared and reviewed poster presentations, meeting reports, status

reports as well as Chemical Transfer Record and Process Technical

Transfer Document and Process Chemistry Safety Review documents.

. Conducted and generated stability and stress test experimental to assure

process protocols are safe and robust.

. Demonstrated and presented practical synthetic procedures for kilo lab

scale-up to departmental colleagues.

. Explored multiple synthetic routes using SciFinder and ISIS applications

to prepare desired products and identify impurities.

. Increased quality product by using isolation and purification techniques

such as crystallization, extraction and flash chromatography.

. Implemented new automation tools such as Gilson Liquid Handler and

reactor blocks, Design of Experiments, High-throughput Screening and

Combiflash chromatography to accelerate process development efforts.

. Member of SuperUser Team for Symyx Electronic Notebook that ensured

compliance with recordkeeping regulations and mentored notebook users in

proper use of Symyx ELN.

. Successfully participated in Process Development Project Management

System (PDPMS) to establish archival system for document recording

purposes for R&D department.

Supported preparation of IND and CMC registrations.

. Compiled and organized required data for specification meetings.

. Assisted in planning, coordination, preparation and review of regulatory

submissions.

. Drafted physical and chemical characteristics for drug substance sections

of INDs.

. Ensured accurate for regulatory filings by creating structures and

synthetic schemes for INDs in Chemdraw.

. Used PhotoFinish for scanning NMR, IR and mass spectra for incorporation

into INDs.

. Assured that all documentation for lab testing is completed, maintained

and processed in a timely manner.

AWARDS

. Received Lab to Plant award for contributions to Symyx Electronic

Notebook project, 2007.

. Received PRI Star Award for timely optimization of pre-penultimate step

for marketed drug, 2004.

. Received Outstanding Achievement Award for Process Research and

Development of marketed drug for Validation Campaign, 2003.

. Received Excellence and Spot Awards for process development efforts for

investigational drug, 1998.

PUBLICATIONS

. "Process for preparation of chloromethyl (halomethyl) benzoate

intermediates for synthesis of azole antifungal agents;" Yang, Wangying;

Wang, Xuebao; Bhattacharya, Apurba; Chau, Melissa. PCT Int. Appl. (2000),

18 pp.

EDUCATIONS

. Certificate, Clinical Research Associate, Kriger Research Professional

Development Program, Toronto, Canada. May 2009

. BS, Medicinal Chemistry, State University of New York at Buffalo, 1993

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