Hitesh Patel
Stevenson Ranch,CA
Summary
Highly experienced leader with 20+ experience in Neutraceutical Product Development, Commercialization and Technical Operations area, offering outstanding product-formulation and trouble-shooting skills for solid dosage forms; Tablet, Capsule, Powder, ODT and Chewable tablet. Familiar with Gummy product development. Total 25+ years of experience of Pharmaceutical drug development/manufacturing+ Nutraceutical/Vitamins-Dietary supplement.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Sr. Manager, Technical Operations, R&D
Natrol LLC (Vytalogy Wellness)
Chatsworth, CA
07.2021 - Current
- Provide technical leadership to Technical Operations/R&D department for Tablet, Capsule, Powder and softgel formulation and manufacturing.
- Provide day-to-day technical trouble shooting on manufacturing floor for Tablet, Capsule, powder, machines etc.
- Conduct R&D bench-trial, Pilot, Scale-up and Commercial batches. Technical transfer the product.
- Create and advise team on generating deviations, change controls, specifications, master batch records, stability protocols and other documents.
- Reformulate existing products (tablet, fast-dissolve/ODT/chewable tablet, 2-pc capsule) for cost savings and other initiatives.
- Qualify new and 2nd vendors for raw materials
- Generate master batch records & specifications for bulk products and raw materials.
- Generate price-quote for new/revised formula, review testing results, sensory evaluation, ,supplement-fact preparation, suggest packaging component etc.
- Review label-claims with regulatory, science and marketing dept.
- Technical transfer the products from sister-company and contract manufacturers.
- Continuously revise and update specifications for raw material and finished bulk products.
- Educate and familiarize QA and manufacturing colleagues on topics covering assay, blend-uniformity, content uniformity, stability, certifications(e.g. USP, organic, kosher, halal, non-gmo etc.).
- Provide support to answer consumers questions.
- Suggest and evaluate new equipments and machine purchase for manufacturing department.
Sr. Formulator & Innovation Scientist, R&D
Natrol LLC
Chatsworth, CA
07.2018 - 07.2021
- Develope new products (tablet, fast-dissolve/ODT/ chewable tablet, 2-pc capsule etc.) involving new active-ingredient sourcing & qualification, running bench/pilot trials, generate formula-price-quote, flavor development, sensory evaluation, conduct stability , supplement-fact preparation, label-claims review with science and regulatory, generate master batch records & specifications for bulk products and raw materials, monitor scale-up and full-size commercial batches, suggest packaging component etc.
- Reformulate existing products (tablet, fast-dissolve/ODT/chewable tablet, 2-pc capsule) including new active-material sourcing and qualification, bench/pilot trials, price-quote, flavor development, conduct stability, supplement-fact-preparations, label-claims review with science and regulatory, generate master batch records & specifications for bulk products and raw materials, monitor scale-up and full-size commercial batch, suggest packaging component etc.
- Technical transfer of new products into manufacturing.
Sr. Formulator, R&D
Best Formulation
City of Industry, CA
06.2017 - 07.2018
- Formulate unit solid dosage products (tablet, powder, softgel, Capsule) in accordance with customer's specifications.
- Conduct bench trial & pilot batches as needed.
- Troubleshoot technical issues on mfg. floor to ensure flawless manufacturing.
- Develop FDA compliant Supplement Facts, Nutrition Facts label from product formula.
- Create and review production manufacturing batch records and specifications.
- Perform other job duties related to job as assigned by manager.
Scientist II
Herbalife Nutrition
Torrance, CA
12.2013 - 05.2017
- Developed new formulations and reformulated existing Tablet, Powder and Softgel product-line by conducting bench trials, feasibility runs, Pilot trials and Stability studies.
- Reviewed and performed physical testing such as disintegration, friability, hardness, thickness, flow, densities, sieve analysis, moisture, and sensory attributes for raw materials as well as finished products.
- Developed flavor and sweetener system for new products and performed sensory evaluation.
Interacted with testing laboratories to analyze, review and verify test results. - Documented and tracked product development activities and metrics in 'Agile' management software system.
- Interfaced with cross-functional team of product-science, marketing, sourcing, quality, Tech. Ops., global/regional regulatory, packaging-engineering, project management and contract manufacturers.
- Utilized FDA and other countries MOH guidelines and regulation for products.
Sr. Formulator
Pharmavite LLC.
Valencia, CA
09.2007 - 12.2013
- Developed variety of dosage delivery forms such as 'softgel, 'tablet', Capsule, Orally disintegrated tablet, Fish Oil-emulsion/smoothie.
- Developed colored and clear gel-mass for new softgel products.
- Sourced new raw materials required for the new product development.
- Prepared and executed bench trials, pilot trials, scale-up batches.
- Prepared documents relevant to area of responsibility such as Master batch records, process verification protocol, raw material and bulk-product-specifications, technical reports, lab-book documentation, stability-protocol, Tech. Transfer/commercialization reports.
- Monitored, evaluated and summarized stability results.
- Achieved hands-on product development knowledge by working on almost all equipments, such as sifter, v-blender/Cross-flow V-blender, Cone/Slant-cone blender, Ribbon blender, Fitz-mill, Tablet-press, Coater, Gel-melter, Co-ball-mill, Tornado mill, Softgel-encapsulator, Capsule filling machine etc.
- Communicated with other departments like product-science, Manufacturing, Quality, Supply Chain, Regulatory, Packaging engineering and contract manufacturers for product development.
- Develop a network of outside contacts such as vendors, consultants, educators and have them visited company to gain benefits.
- Presented ideas and suggestions for new products or process improvements.
- Achieved cGMP, SOP and other job-related training and seminars to stay current with Dietary supplement Industry.
R&D Formulator
Best Formulation
City of Industry, CA
01.2007 - 09.2007
- Developed Oil and Suspension-based softgel.
- Developed new gel masses with different colors.
- Sourced and evaluated new raw materials required for the new formulation and reformulation.
- Generated formulation and bulk-cost-quotes for new formulas for customers.
- Generated master batch records and other necessary documents for production batches.
- Generated "Nutritional Fact" information for new product label.
- Communicated with customer regarding their order of new products.
- Participated in Vegetable-gel development and manufacturing process.
Associate Formulator
Herbalife Nutrition
Century City, CA
05.2006 - 01.2007
- Supported reformulation of a protein-drink-mix project to optimize flavors.
- Organized and performed sensory evaluation for reformulation for reformulation project.
- Requested and Reviewed necessary documents for new flavors such as product data sheet, Certificate of Analysis, MSDS, GRAS, Allergen, Country of Origin, Kosher/Halal, BSE/GMO /Allergen etc.
R&D Formulation Chemist
PureTek Corporation
San Fernando, CA
03.2006 - 05.2006
- Supported formulation of tablet, face powder and cream.
- Performed physical testing and bench trial work for product development.
- Monitored and gathered in-process parameters and data for pilot and scale-up batches.
- Requested and maintained necessary documents for raw materials and finished products.
Sr. Research Associate
IVAX(TEVA) Pharmaceuticals
Northvale, NJ
05.2003 - 06.2005
- Support development of drug-products such as Divalporex Sodium Tablet, Hydrochlorothiazide Tablet, Carvedilol sodium Tablet etc
- Conducted bench trials(blending, compression and coating) of various drug products.
- Performed physical testing of drug products.
- Monitored pilot and scale-up batches, gathered and analyze testing data of pilot and scale-up run.
Education
Bachelors in PHARMACY - Pharmaceutical Sciences And Pharmacy
University of Poona
Poona, India05.1994
Skills
- New product development/formulation; Tablet, Capsule, Softgel, Powder, Chewable/ODT/Fast-Dissolve tablet
- Production improvements and Reformulation of existing products; Tablet, Capsule, Softgel, Powder, Chewable/ODT/Fast-Dissolve tablet
- Technical trouble-shooting on manufacturing floor
- Cost saving projects/initiative; replacing branded expensive active ingredient with generic
- Technical transfer & commercialization
- Raw material evaluation & qualification,
- Result oriented and complex problem solving
- Judgmental and quick decision making
- Cross-functional collaboration
- Quality, cGMP, SOP, USP, FDA regulations
- Excellent written & verbal communication skill
- Managerial skill
Certification
- August 2015: Colorcon coating school, Irvine, CA
- June 2015: Colorcon Formulation school, Irvine, CA
- June 2015: Beverage 201, Fona Flavor University, Orange County, CA
- June 2016: Microsoft Excel, New Horizons computer Training.
- November 2014: cGMP Trtraining, Dietary Supplement.
- September 2004: GMP training at IVAX Pharmaceuticals.
- March 2005: Eudragit Workshop by Degussa at IVAX Pharmaceuticals.
- July 2004: HOSOKAWA Micron powder characteristics training.
- January 2002: Glatt Auto-coater process Training.
Timeline
Sr. Manager, Technical Operations, R&D
Natrol LLC (Vytalogy Wellness)
07.2021 - Current
Sr. Formulator & Innovation Scientist, R&D
Natrol LLC
07.2018 - 07.2021
Sr. Formulator, R&D
Best Formulation
06.2017 - 07.2018
Scientist II
Herbalife Nutrition
12.2013 - 05.2017
Sr. Formulator
Pharmavite LLC.
09.2007 - 12.2013
R&D Formulator
Best Formulation
01.2007 - 09.2007
Associate Formulator
Herbalife Nutrition
05.2006 - 01.2007
R&D Formulation Chemist
PureTek Corporation
03.2006 - 05.2006
Sr. Research Associate
IVAX(TEVA) Pharmaceuticals
05.2003 - 06.2005
Bachelors in PHARMACY - Pharmaceutical Sciences And Pharmacy
University of Poona