Quality Control Development

Falguni Kher

**** ******* **** #*** ****** City, CA 94404

C: 650-***-**** Email: ******@*******.***

Citizenship: U. S. Citizen

CAREER OVERVIEW

Seeking a Research Associate position in QC/Analytical Chemistry to enhance the productivity and success of the company through my acquired skills and professional experience of 5+ years in the Pharmaceutical / Biotechnology Industry.

QUALIFICATIONS

Analysis of raw materials, in-process, and finished Drug Products

Operation/ Maintenance/Troubleshooting HPLC, GC, LCMS, FTIR, UV, KF, NMR

QC & Drug Development Process

Development, Qualification/Validation of Analytical test methods

Release Testing and Stability Testing of Drug Products.

Method Transfer of Analytical methods

Experienced with Laboratory Instrument Software, including LIMS

Development of Chiral/Achiral HPLC method

Cleaning Validation / Dissolution Testing

Multistep Organic Synthesis of small molecules

Process scale-up and process development

Purification and Characterization of Synthetic Small Molecules

Knowledge of U.S. FDA guidelines

Document, Interpret & Summarize Data

R&D and cGMP production in Organic Synthesis

Strong organizational, written and oral communication skills

Experience using MS Office

WORK EXPERIENCE

Paxterra Solutions - San Jose, CA / Bangalore, India (2007 – 2010)

Paxterra Solutions is boutique software outsourcing services company catering to product development and product test/QA services and technical training services for large MNCs to small startups.

Project Coordinator Operations

• Ran overall day to day operations, resource management and schedules.

• Worked closely with global team regarding business development and program/project coordination

Johnson Matthey - Fort Devens, Massachusetts (1995 – 2001)

Johnson Matthey provides contract research, process development and small-scale synthesis services to

the pharmaceutical industry. Johnson Matthey’s services are primarily focused on drug development

from discovery through to Phase II clinical trials.

Johnson Matthey - Analytical Chemist (1999-2001)

• Developed, reviewed, wrote Analytical test methods / SOPs.

• Coordinated with contract labs & manufacturing to transfer analytical methods.

• Performed method qualification, instrument validation, developed stability test methods and protocols.

• Provide oversight of quality control responsibilities that includes testing and release of drug products.

• Worked in a cross-functional team including QC, QA, Analytical, Research, and Manufacturing.

• Attended formal training on HPLC & GC Separation and method development, cGMP practices.

Johnson Matthey - Senior Quality Control Chemist/ IT Assistant (1997-1999)

• Performed analysis of drug compounds/research samples using analytical instrumentation, including HPLC, GC, LCMS, NMR, Karl Fischer, UV, TGA/DSC & other wet lab chemistry techniques.

• Summarized and interpreted data, documented studies in laboratory notebook.

• Performed and Coordinated Stability testing program of drug products.

• Supported the pilot plant QC department and process scale up.

• Wrote SOPs, test methods, performed instrument validation, cleaning validation.

• Member of the IT group, setup, maintained and managed the QC/Analytical lab network/ lab instrumentation.

• Tested raw materials, intermediate and final Drug Products using test methods, qualified standards.

• Operated, maintained, troubleshot Analytical Instrumentation such as HPLC, GC (Waters Alliance, HP Chemstation, Varian)

• Investigated Out of Specifications.

Johnson Matthey - Organic Chemist (1995-1997)

• R&D/ Synthesized compounds – drug discovery, process development and small scale GMP production.

• Worked on multistep organic synthesis projects for drug discovery for clients such as NCI and NIH.

• Conducted scale up process optimization of compounds for cGMP pilot plant production.

• Performed cleaning validation for Pilot Plant/ cGMP production apparatus.

Cambridge Neuroscience Cambridge, Massachusetts Internship 1995

Organic Chemist

• R&D/ synthesis of small molecules/compounds.

EDUCATION & TRAINING

Advanced Diploma Clinical Research - Institute of Clinical Research India (ICRI), Bangalore, India (2010)

Certificate in Data/Telecommunication - University of Massachusetts, Lowell, MA (1998)

Bachelor of Science, Chemistry - University of Connecticut, Storrs, CT (1995)

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