KAMLESH MANDAVIYA

** ********* ***., ***. ** • Jersey City, New Jersey 07306

201-***-**** • uiv4ij@r.postjobfree.com

ENTRY/MID-LEVEL POSITION: Formulation & Process Development Scientist

Highly skilled product and process development professional with proven expertise supporting drug research and development for leading industrial pharmaceutical manufacturers. Details-focused formulation scientist with extensive experience designing, planning, and conducting comprehensive research, analysis, and experimentation to drive the development of new drug formulations and products. Results-oriented scientific manager with a track record of ensuring quality assurance and control across the entire development and manufacturing spectrum.

Product Development • Process Development • R&D • Formulation Science • Method Validation • Testing • Quality Control

Quality Assurance • Problem Identification & Resolution • Protocol Design • Regulatory Compliance • Record Keeping

Reporting • Communications • Management • Equipment Maintenance & Calibration • Collaboration

PROFESSIONAL EXPERIENCE

TREFFER PHARMACEUTICALS LTD., Navsari, Gujarat • 2005

Manufacturer of generic and over-the-counter medications, with ~1.5K employees.

Analytical Chemist: Conducted raw material and impurity testing, as well as other testing and analysis, to support the development and manufacture of drugs and products. Ensured complete quality control and compliance with all FDA/ICH regulations for all actions in the manufacture and packaging of tablets. Validated methodology and processes. Performed complete and accurate documentation and record keeping, including batch record keeping. Designed working standards in accordance with corporate and regulatory SOPs. Maintained and calibrated equipment to ensure continually high levels of accuracy and quality of manufacturing and production.

SUN PHARMACEUTICALS LTD., Mumbai, India • 2005–2006

Leading pharmaceutical company in India, with ~20K employees worldwide.

Formulation & Process Development Associate: Designed and developed analytical test methodology, qualifications, and validations for the development of drug products, from preformulation to scale-up. Generated, prepared, and analyzed new formulations and compounds in cGMP facilitate labs. Identify & evaluate critical process parameters. Orchestrated pilot batch testing and stability studies to help drive product quality and stability. Evaluated raw materials and new products to assess a wide range of critical factors. Conceived experimental designs to support production scale-up, lyophilization, and transfer of technology, among other areas. Performed protein purification & characterization as well as ELISA & Western blot test, Cell line construction, Recombinant protein expression. Created technical protocols and reports for all investigations and actions enacted.

PARKCHESTER FAMILY PHARMACY, Bronx, New York • 2010–Present

Retail pharmacy providing a full range of services to the local community.

Pharmacy Technician & Manager: Interface with customers to fill prescriptions and provide prescription counseling. Manage and maintain inventory, including controlled and narcotic drugs. Perform complete filing and billing for Medicaid, Medicare, and worker’s compensation programs. Execute thorough and accurate audits to reduce incidence of errors and improve operational effectiveness. Effect prescription reconciliation for program and 3rd-party reimbursements. Provide follow-up for rejected claims.

EDUCATION

Master of Science, Industrial Pharmacy // Long Island University, Brooklyn, New York (2006-2009)

Bachelor of Pharmacy, Pharmacy // Maliba Pharmacy College, Bardoli, Gujarat, India (2001-2005)

KAMLESH MANDAVIYA • Page 2 • uiv4ij@r.postjobfree.com

Computer skills: Microsoft Excel, Power Point, Word, Windows Vista & XP

Technical/Equipment Expertise: UV Meters (Hitachi 2000 & Shimadzu), Karl Fischer Titration, Thin Layer chromatography, HPLC (Waters & Shimadzu With Empower and Total Chrome 60.2 Software), IR (Avatar 370), FTIR, Wet Chemistry Techniques, Gas Chromatography (GC, Shimadzu 2010), FTIR, NMR, MS, cGMP practice, In-Process Testing, Familiar with Instrumental Qualification(IQ), Operational Qualification(OQ), Performance Qualification(PQ), Well trained in chromatographic techniques CD, DSC, DLS, UV and fluorescence. Particle size evaluation, Microscopy.

Languages: English, Hindi, Gujarati