Ankit Rathi Email & Phone Number

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Chino, California, United States

Chino, Ca

Quality Assurance achievement summary- - Trained PCQI professional, executed compliance for 21 CFR Part 117, 110 and 111.- Faced multiple US FDA auditsResult: No observations, no 483's issued.- Faced and successfully completed GMP certification from external certification agency.- Developed and implemented HACCP plan for food manufacturing policy. - Certified food safety professional with HACCP, advanced HACCP, PCQI, FSMA, FSVP certifications- Installed and validated ICP, enzymatic assay as per USP, FCC standards; Blender validation, cleaning validation, allergen cleaning validation and process validation- Trained and Led team of 4 for GMP compliance for 21 CFR Part 110, Part 111 and Part 117 compliance- Completed over 50+ training sessions of over 40 employeesRegulatory affairs achievement summary-- Successfully Faced total of 12 audits from customers, KOSHER, HALAL, CA State FDA, US FDA and county inspections- Developed product registration documents for animal feed enzymes and successfully 6 products for animal feed across 6 states in USA and 12 countries worldwide- Certified food safety professional with HACCP, advanced HACCP, PCQI, FSMA, FSVP certifications- Created 6 Drug Master Files (DMF) for registration of product in US, Europe, Canada, Australia and latin american countries

Chino, California

Quality Assurance achievement summary- - Trained PCQI professional, executed compliance for 21 CFR Part 117.- Faced 2 US FDA audits in Dec 2016 and Jan 2017 Result: No observations, no 483's issued.- Faced and successfully completed GMP certification from external certification agency.- Developed and implemented HACCP plan for food manufacturing policy. - Certified food safety professional with HACCP, advanced HACCP, PCQI, FSMA, FSVP certifications- Installed and validated ICP, enzymatic assay as per USP, FCC standards; Blender validation, cleaning validation, allergen cleaning validation and process validation- Trained and Led team of 4 for GMP compliance for 21 CFR Part 110, Part 111 and Part 117 compliance- Completed over 50+ training sessions of over 40 employeesRegulatory affairs achievement summary-- Successfully Faced total of 12 audits from customers, KOSHER, HALAL, CA State FDA, US FDA and county inspections- Developed product registration documents for animal feed enzymes and successfully 6 products for animal feed across 6 states in USA and 12 countries worldwide- Certified food safety professional with HACCP, advanced HACCP, PCQI, FSMA, FSVP certifications- Created 6 Drug Master Files (DMF) for registration of product in US, Europe, Canada, Australia and latin american countries

Chino, California

Responsibilities - Quality control and assurance for 21 CFR part 110, Part 111Developing cGMP, approving of batch cardsReviewing of results, forms and cleaning tasks Qualifying vendors Monitoring quality testing of EnzymesMonitoring production unit operations Developed Safety Data Sheets for all products Technical assistance to customers Customer service

Orange County, California Area

A non-profit dedicated to using research, interactive learning, and self-monitoring to educate the public about all treatments, including natural, supplemental, and alternative therapies, for treating chronic Pulmonary Fibrosis.

New Brunswick, New Jersey, Usa

STRATEGIC PRODUCT MANAGEMENT• Optimized strategies for Alferon Production (Protein) and independently authored 10 SOP's and 2 Batch records• Coordinated between various departments to streamline product development and management procedure PROJECT MANAGEMENT AND ANALYTICS• Initiated, planned and executed project to manufacture serum in house to achieve success and reducing cost by 40%• Strategized Steam In Place protocol to achieve reduction of bioburden within specification and save 20% time Accountable for formulation and process development of drugs used in treatment of immune disorders and viral diseases-Process Development-o Development of operations in the manufacturing of blood derived products such as Cell isolation and culture, solution formulation, sterile component preparation, cell harvesting, bulk liquid concentration, preparative chromatography and related operationsOperations-o Experience in operations related to Bioreactors, Autoclave, Washers, Continuous and batch centrifuges, Filtration unit, Concentration units, Purification systems and carry out their effective analysis.o Scale up of fermentation process in bioreactors.cGMP document development-o Write SOP's and validation protocol for purification steps and chromatography steps.Validations-o Perform calibration and IQ/OQ/PQ execution using Kaye Validator.o Independently developed and authored over 10 SOP's and 5 IQ/OQ'so Executed over 25 IQ/OQ's and 8 PQ'so Tracked calibration of over 116 equipment's in manufacturing facility o Deal with external calibration company for timely calibration of instruments to meet the cGMP guidelinesMaintenance-o Responsible for maintenance and daily activity tracking of Purified water system and water for Injection systemso Tracking and maintaining of logs of over 35 filters and integrity of filtero Maintaining and tracking raw material inventory

New Brunswick, Nj

RESEARCH AND INNOVATION- (Dr. Dismukes group)• Created genetic Knockout Mutants of key enzymes in Metabolism led to 6x production of Hydrogen than orignal• Analyzed large sets data to develop and optimized easier and faster protocols to analyze Glycolysis metabolites and Hydrogen production from mutated Algae stains led to 50% time reductionMetabolic Engineering for higher production of Hydrogen in Synechococcus sp 7002. We have mutated several genes of 7002 to engineer metabolism that will lead to knockdown of several enzymes in metabolic pathway producing more hydrogen. I have been using various cutting edge instruments like LC-MS/MS, GC, HPLC to understand effect of metabolic engineering.Keywords- Molecular Biology, Analytical Chemistry, Biochemistry, Microbiology, BiofuelsPRODUCT DEVELOPMENT- LEADING TO SUCCESSFUL STARTUP (Dr. Raskin's group)• Developed sugar free, berry-based nutraceutical supplement for the treatment of diabetes and obesity, leading to successful startup• Forecasted sales, cost and researched market and conducted phone interviews to understand and launch company

Cranbury, New Jersey

Freyr Provides regulatory services to pharmaceutical companies. I was working on Project with J&J on Publishing of consumer products to FDA. I have published over 12 products and working on 3 labeling assignments.

Mumbai Area, India

CREATIVE SOLUTIONS-• Developed 3 new applications for Serratiopeptidase (enzyme) for use in the pharmaceutical industries• Provided consulting services for setup of laboratory equipment and SOP development for 2 clients

Doctor Of Philosophy - Phd, Biotechnology

Master’S Degree, Biotechnology And Genomics, Gpa - 3.71

Activities and Societies: Professional Science Masters Students association, Graduate Students Association, Biotechnology Students.

Bachelor Of Engineering (Be), Biotechnology, Gpa- 3.97

Activities and Societies: Walk With World Biotechnology Student Association Kacharawala