Gaurav B Patel
Bensalem,PA
Summary
Accomplished Research Scientist with expertise in synthetic chemistry and process optimization at NAVINTA LLC. Proven track record in developing commercially viable multi-step syntheses and ensuring cGMP compliance. Strong analytical skills and exceptional organizational abilities have led to successful technology transfers and improved production efficiencies.
Overview
13
13
years of professional experience
Work History
Research Scientist
NAVINTA LLC
Ewing, New Jersey
03.2018 - Current
- Designing of synthetic schemes for synthesis of API intermediate & API’s
- To operate analytical instrument such as HPLC, LCMS, NMR for reaction monitoring and trouble shooting
- To do literature search, costing, feasibility, process development, process optimization, laboratory scale up, plant scale up
- To Prepare and review of documents such as technology transfer document, process development report, manufacturing related document such as manufacturing and cleaning batch records, packing records etc
- To manage the production of active pharmaceutical ingredients (API)
- To ensure that adequate supplies of process materials (raw materials, solvents, reagents, etc.) and operation equipment (hoses, reactors, glassware, etc.) are available for assigned tasks
- To ensure that approved processes are carried out according to cGMP guidelines and are properly documented
- To keep Quality Assurance and Quality Control departments updated regarding to project requirements and schedules
- To carry out the process development, product transfer demonstration to plant, Plant validation and troubleshooting
- To ensure that completion of logbooks and documentation (dispensing record, BPRs, cleaning records, deviation reports, CAPA etc.) related to production accordance with regulatory requirements
- To preparation of SOP’s and actively involvement in route cause analysis of OOS and OOT
- API Projects handled: DEA schedule II substance (Remifentanil hydrochloride, levorphanol tartrate dihydrate), salcaprozic acid, sodium oxybate, Phenobarbital
Research Scientist
APOTHECON pharmaceuticals
Baroda, Gujarat
05.2012 - 02.2018
- To do literature search of new drug molecules of interest
- Conduct in-depth analysis of all literature for process selection strategies
- Responsible for process optimization to meet the required specifications for intermediates and for API
- To do cost reduction, yield improvement, solvent recovery
- Identification and characterization of molecules by using techniques such as NMR, HPLC, MS, XRD etc
- Develop commercially viable, multi-step, organic syntheses for the manufacture of small-molecule active pharmaceutical ingredients
- To review technical documents, process development reports, batch manufacturing records etc
- Maintain notebooks for all research and development experiments
- Responsible for technology transfer demonstration for active pharmaceutical ingredients
- Responsible for the preparation of technical reports and provide technical support regarding API production
- Design QbD experiments to establish a robust manufacturing process
- To ensure that adequate supplies of process materials and operation equipment are available for assigned tasks
- To prepare and review production related documents such as manufacturing and cleaning records, packing records etc
- To ensure that approved processes are carried out according to GMP guidelines and are properly documented
Education
Master - Organic Chemistry
A.N. Patel Science College
04-2012
Bachelor’s - Chemistry
M.B Patel Science College
04-2010
Skills
- Literature search
- Synthetic chemistry
- Process optimization
- Process development
- Technical documentation
- Laboratory scale-up
- cGMP manufacturing
- Manufacturing documents
- Ability to operate analytical instruments as HPLC, LC-MS, DSC, NMR
- Ability to operate Empower/lab solution software
- Mestre-Nova software
- Knowledge of chemistry software
- Chem Draw
- SciFinder / Espacenet / Patent lens
- Technical writing
- Interpretation of analytical data
- Strong organizational skills
- Time management skills
- Understanding of patents / patent claims
- Microsoft Office
- Internet browsing
Personal Information
- Date of Birth: 10/11/89
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
English
Professional
Hindi
Full Professional
Gujarati
Full Professional
References
References available upon request.
Disclaimer
I hereby declare that above mentioned information is true to the best of my knowledge.
Timeline
Research Scientist
NAVINTA LLC
03.2018 - Current
Research Scientist
APOTHECON pharmaceuticals
05.2012 - 02.2018
Master - Organic Chemistry
A.N. Patel Science College
Bachelor’s - Chemistry
M.B Patel Science College
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