Chemist/Project Manager

Objective:

To take a creative role to work on projects in the field of analytical and organic chemistry and implement the expertise and experience gained and develop quality compounds useful for the organization.

Education: Bachelor of Science in Chemistry, Sardar Patel University, Gujarat, India - 1995

Master of Science in Organic Chemistry, Sardar Patel University, Gujarat, India - 1997

Awards: Award as a Gold medal by standing 1st in the university, in June 1995

Experience:

2004- Present KVK-TECH, INC. Newtown, PA

Sr. Scientist:

• Write and implement SOP, IQ, OQ, PQ for laboratory equipments.

• Write Laboratory Investigation Report, Out-of-Specification investigation, Out-of-trend analysis report and CAPA.

• Utilized statistical data control (SDC) techniques to improve quality of product.

• Prepare and validated in-house MS Excel sheet for Laboratory data calculation.

• Prepare QBR documentation for FDA filings.

• Acted as liaison between company and contract testing laboratories.

• Keep record for all controlled substances laboratory usage as per DEA requirements.

Scientist (started as a Research & Development Chemist):

• Helped to commence the new pharmaceutical lab with the help of senior scientist and FDA consultant.

• Prepared IQ, OQ, PQ and SOP (standard operating procedures) for all laboratory instruments.

• Prepared analytical method for all API, excipients and drug products as per USP-NF and suppliers COA. Established specification for all analytical methods after discussing various aspects of FDA as well as company’s requirements.

• Prepared specification and justification for drug product and drug substances.

• Implemented systems to increase consistency between team members.

• Trained chemists and an intern student on the proper usage of analytical instrumentation and analysis of official samples.

• Provided technical support in addressing complex analytical issues.

• Provided analytical support to assist the achievement of production goals and to aid ANDA batch and process validation batches analysis.

• Developed and validated analytical methods.

• Prepared primary reference standards for quality testing and evaluation.

• Reviewed analyst data book and all laboratory log books for compliance.

• Performed required maintenance on lab instrument and Shimadzu HPLC class VP series HPLCs.

2002- 2004 Amide Pharmaceutical Inc. (Now known as Actavis Pharmaceuticals)

Research & Development Chemist

• Performed various analytical testing to support the formulation development group to obtain the bio-equivalent drug product formula.

• Developed analytical method for assay, dissolution and impurities tests with the help of senior chemist.

• Maintained proper record and routine follow-up for all laboratory instrument calibration.

• Reviewed API manufacturer’s technical dossier and communicate to obtain required information like impurity profile, usage of residual solvents during manufacturing of API, route of synthesis, polymorphism, isomerism, particle size and other physical tests as well as required regulatory documents.

1997 - 2002 Aventis Pharma Limited India (Now known as Sanofi-Aventis)

QC Executive officer (July-2001 to February-2002)

• Managed laboratory functions, including work planning of operators.

• Examined all instrumental analysis cost for coming year budget planning.

• Performed quality control testing using chromatographic Instrumental like HPLC and GC of Drug products, Drug substances In-process samples, Raw materials and recipients.

• Performed analytical method validation, method transfer and report preparation.

• Calibrated and Performed Maintenance of all Laboratory equipments at regular intervals.

• Update and maintain all laboratory documents as per cGMP and cGLP guideline and our In-house Global quality Standard.

• Prepared and update required documents as company is seeking WHO, ISO 9002 and ISO 14002 certification.

• Analytical Method Setup on HPLC and GC for the new products.

1997 - 2001 Hoechst Marion Russell Limited India (Now known as Sanofi-Aventis)

QC Officer (July-1997 to July-2001)

• Performed quality control testing on raw materials, intermediates, and final products as per Current GLP Using USP, BP, EP, JP and IP.

• Resolved problems associated with the physical properties of raw materials during sampling.

• Classical Analytical Method Validation and report preparation.

• Day to day activity feedback meetings with QC Executive officer.

Hands on Analytical instrument:

HPLC: Shimadzu’s VP series HPLC with Class VP and Turbo Chrom client service (TCCS) Software. Hewlett Packard HP1100 with Chemstation Software. Waters LCModule 1 with millennium software.

Particle Size Analyzer: Malvern Master seizer –S.

Differential Scanning Colorimeter (DSC): Mettler Toledo DSC Polymer

UV Spectrophotometer: Shimadzu UV-VIS 1700 Spectrophotometer with TCC control, Shimadzu FTIR 8400S.

Other laboratory equipments: Tablet Dissolution Apparatus (I, II and III), Metrohm Karl Fischer auto titrator, LVTDV-1 Brookfield Viscometer, Disintegration machine, Polarimeter, Refractometer, Analytical Balances, Melting Point Apparatus etc.

Knowledge on Analytical instrument:

UPLC: Waters Acuity UPLC with Empower software.

FTNIR: Perkin Elmer Paragon Identicheck FTNIR Spectrometer.

Gas Chromatograph: Shimadzu GC17A with Perkin Elmer Headspace sampler.

Presentations

• Life cycle of malarial parasites, February 1997

• System Suitability Overview, to expedite proper inter-laboratory planning, August 2001

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