Development Software

GHANSHYAM PATEL

* ******** ****

Nanuet, NY *****

Phone: 845-***-****

Email: ****************@*****.***

SUMMARY:

Senior Analytical Chemist with over 25 years of experience in Research and Development & Quality Control in pharmaceutical industry. A technical troubleshooter with strong analytical, technical and motivational skills. Team player with strong commitment to accept challenges. Able to implement and initiate new ideas.

TECHNICAL SKILLS:

GMP/GLP, HPLC with Waters Millennium, Empower Software and Perkin Elmers Turbochrom 4.1, GC FID (Analysis including Headspace techniques with Agilent Chem Station) and Empower software. UV-VIS, FTIR, DSC, Microtrac X100, Sympatac, NIR, Automated Dissolution apparatus, Acuity UHPLC with Waters Empower 3 software, PDA, Refractive Index, Conductivity, MP apparatus, TLC, Potentiometer, Karl Fischer, Specific rotation.

PROFESSIONAL EXPERIENCE:

Senior Analytical Chemist 06/2018-Present

Analytical Research & Development

Orit Labs, an Alembic Company, West Caldwell, NJ

Method Development and Method Validation of new ANDA projects.

Method Development of assay, impurity, dissolution and particle size methods etc.

Literature review and DMF review of API.

Preparation and review of Method Validation Protocol, Reports and Investigation.

Review and response to FDA deficiency in timely manner.

Trained new chemists to perform day to day analysis.

Manage the subordinate chemist and keep tracking of ongoing and upcoming projects.

Provide support to the Formulation and Development department with Excipient compatibility studies for new product development.

Short term stability studies for formulation and development support as well as regular stability studies for the ANDAs.

Calibration of analytical instruments like HPLC and Dissolution apparatus.

Conducting technology transfer of analytical method from source laboratory to destination laboratory.

Senior Analytical Chemist 05/2006-06/2018

Analytical Research & Development

Par Pharmaceuticals, Inc., Spring Valley, NY

Execute the Method Validation and Method transfer protocol of Assay, Dissolution, Impurity and Residual solvent Method Validation for Active drug Substances (API), Finished Products and Excipients including linearity, recovery, placebo non-interference, ruggedness, robustness, solution stability and specificity and precision studies.

Draft analytical method validation protocol and report, stability study protocol and report and monographs for finished product and Analytical COA.

Developed HPLC, UV, GC, UPLC Methods for Assay, Content Uniformity,

Impurities/Degradants, Cleaning Validation, Dissolution and Particle size for the raw materials and different dosage forms such as solid, oral suspension, ointment, nasal spray, and cream.

Technical skills in the Dissolution method validation for extended and immediate

drug release of finished product.

Routine analysis of API, research, submission batch and in process release samples as well as stability samples.

Familiar with ICP and LC –MS software.

Extensive experiences in HPLC,UHPLC and GC instrument trouble shooting and method

innovation.

Review Method Validation Protocol, Report and peer data review as per cGMP and SOP

Trained new hires and mentored juniors.

Senior Chemist 1999- 04/2006

Analytical Research & Development

Ivax Pharmaceuticals, Inc., Northvale, NJ

Authored several method validation protocols and reports.

Developed several HPLC, UV, GC and UPLC methods for Assay, Impurity and Content Uniformity validations for the raw materials and drug products.

Undertook comprehensive analytical method validation utilizing an array of instrumentation (HPLC, UPLC, GC and Ditek Online Dissolution systems).

Analyzed active drug substances, in process sample release, stability samples.

Performed Dissolution method validation for extended release and immediate drug release. of finished products.

Single-handedly and successfully performed the calibration of the USP Dissolution test

Methods using Salicylic Tablet and Prednisone Tablet.

Chemist 1989-1999

Quality Control

Zenith Laboratories, Inc., Northvale NJ

Responsible for the chemical analysis of finished products and raw materials as per In-house,

USP and NF methodologies.

Executed method development, and method transfer protocols employing HPLC, GC, etc.

Preparation and standardization of volumetric solutions for raw materials testing.

Familiar with PE Nelson Turbochrom Chromatography data system and PE Nelson LIMS.

Expertise in the calibration of HPLC, UV, Dissolution, DSC, Thermometer, IR, and pH meter, Microtrac X100 particle size analyzer.

Experienced with cGMP & GLP compliance issues with in depth knowledge of its documentation requirements.

Extensive experience in performing wet analysis including Extraction.

TRAINING:

Unveiling the Mysteries of Reversed-phase HPLC Method Development April 2000

By Advanza of Phenomenex

Practical Gas Chromatography: Packed and Capillary Columns November 2000

By Eastern Analytical Symposium, Inc.

Dissolution Method Development October 2001

By Eastern Analytical Symposium, Inc.

Water Empower Software and Alliance Technology Training November 2003

By Waters Corporations

Introduction to Computers December 2003

By JVS

Microsoft Word and Excel Training December 2003

By JVS

Good Manufacturing Practices (GMP) September 2004

By JVS

HPLC method Development and Validation November 2004

By Eastern Analytical Symposium, Inc.

EDUCATION:

Bachelor of Science in Chemistry May 1983

Gujarat University, Ahmedabad, India

LANGUAGES:

Gujarati, Hindi and English

REFERENCES:

Upon Request

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