John Vitale Email & Phone Number

Pompano Beach, Fl, Us

Pompano Beach, Fl, Us

Pompano Beach, Fl, Us

• Responsible for safely and effectively developing and optimizing product formulations including methodologies for analysis• Responsible for safely and effectively developing, establishing, and validating analytical testing methodologies• Ensures that all analytical testing activities comply with applicable compendia and FDA/ICH regulatory guidance• Implements new programs and technology within analytical development to meet company objectives.• Authors, reviews, and/or approves key documents such as Standard Operating Procedures, change controls, deviations, and investigations, analytical methods, validation protocols, and reports, etc.• Represents Analytical Sciences in verbal and written communications with regulatory agencies and presenting research and analytical findings to senior leadership and across the organization

Pompano Beach, Fl, Us

•Author and revise Standard Operating Procedures in accordance with cGMP and FDA Guidelines•Write and conduct Planned and Unplanned Deviations•Author Change Controls and Revisions of Procedures, Formulae, and Batch Records•Reformulate topical pharmaceuticals such as gels, creams, suspensions, and solutions•Create lab scale batches as well as production scale-up batches•Perform validations and method development on new test methods•Complete routine testing on R&D products•Calibrate and maintain a Total Organic Carbon testing apparatus

St Louis, Missouri, Us

•Supervise a team of chemists and technicians performing quality control testing on FDA regulated animal drug products and veterinary medicine in a cGMP setting•Author and conduct Out of Specification investigations, Deviations, and Change Controls•Write and revise SOPs (Standard Operating Procedures) for analytical methods and workplace procedures•Train quality control team on any new or revised SOPs•Make in-process batch adjustments (pH, Assay, viscosity, API) when needed for all formulas•Review all test results, lab notebooks, and batch records for GDP (good documentation practices) compliance•Perform preventative maintenance and calibrate instruments for all methods•Aid in performing HPLC, microbial, and physical testing in the lab when needed to support production•Maintain and oversee stability testing program for all products•Track and ship samples for third party testing

New York, New York, Us

•Perform GCMSMS, LCMSMS, GCMS/FID testing on flavor/fragrance raw materials and finished goods•Testing includes wet chemistry, sample preparation, and data analysis of samples•Tests Performed: Agricultural Residues, Phthalates, Allergens, Coolers, Illegal Dyes•Author SOPs (Standard Operating Procedures) for new analytical tests or localizations of tests•Modify and test new analytical methods for GCMS and LCMS•Perform preventative maintenance and calibrate instruments for all methods

New York, New York, Us

•Train new users on device operation and maintenance•Author SOPs for new analytical methods and update existing SOPs•Design experiments and work with international team to improve capabilities of new instrument•Identify and explore experiments for the acquisition of intellectual property•Perform root cause analysis to identify process improvements •Use data visualization techniques to process instrument data•Apply knowledge of flavor/fragrance library to create new experiments and applications•Use GC/GCMS and other analytical methods to benchmark and calibrate new device•Deliver presentations on results to team and executives

Carteret, New Jersey, Us

•Performed QC analysis and testing for chemicals and essential oils•Formulated new essential oil blends and fragrances from analytical data and customer requests•Maintained inventory via toll work and stock batches•Analyzed gas chromatography and mass spectrometer (FID/TCD/MS) chromatograms•Was responsible for GC and GC/MS method development•Authored SOPs for new analytical methods and updated existing SOPs•Performed R&D work on new oils and chemicals purchased by the company•Received training in SQF Level 3 protocol, cGMP, and HACCP•Worked with production supervisors and technicians daily on materials and blends•Performed preventative maintenance and validation on multiple brands of GC and GCMS•Performed root cause analysis on issues encountered in the manufacturing process

Wilmington, De, Us

• Performed mass balancing and data analysis on continuous system• Provided weekly PowerPoint presentations on test results to department and supervisors• Modeled and analyzed effects on changes within Research & Development TiO2 system• Assisted in assessing costs for design changes• Streamlined data reporting format• Redesigned system inventory and digital recordkeeping

New York, Ny, Us

• Shadowed engineers designing makeup and skincare products in batch processes• Assisted in formulation and benchtop scale labs• Helped guide 1-3 technicians through experiments• Helped solve equipment malfunctions• Assisted in Preventative Maintenance (PM) and development of PM system

Master Of Business Administration - Mba, Project Management

Bachelor Of Science (B.S.), Chemical Engineering