Sanjay Bhavsar Email & Phone Number

Danbury, Ct, Us

Danbury, Ct

Stratford, Ct

Promoted to manage and direct daily activities for up to 8 Laboratory Technical Services team members. Ensured testing was performed accurately in compliance with company policies and procedures including federal, state and local (FDA, DEA, cGMP and OSHA) regulations. Managed wide range of projects including: Analytical Method Development and Validation (finished product and drug substance of Assay/Content Uniformity/Dissolution/Impurities method), Non-routine Laboratory Investigations, Out of Specification (OOS) results investigations, Analytical Method Transfers, Establishment of Specifications, and In-House Reference Standard Qualifications. Designed and approved protocols for scientists.Created cleaning validation protocols, established appropriate specifications, trained production staff on appropriate swab techniques, coordinated tasks with members of other departments and evaluated, reviewed and approved routine test. Cleaning validation activities (i.e. trace analysis) included method development and validation of cleaning validation procedures for about 19 new and transferred drug products. Led project to convert current particle size procedures from the Malvern 2600 to the Malvern Mastersizer S or Sieve (Alpine-jet Sieve, Sonic Sifter or Ro-Tap). Performed method development and validation of particle size methods for about 15 products and proposed new specifications in order to meet current regulatory requirements. Led intra- and inter-departmental teams accountable for transferring analytical test methods to contract laboratories and other company facilities both domestically and abroad (California, Florida, Puerto Rico and India). Provided analytical and technical support for on-time project completion.Supported Laboratory System Administrators for Empower (electronic laboratory data collection system) by performing the technical review of modifications submitted through the change control system.

Held positions of increasing responsibility including performing method investigations, developing and validating analytical method for both Active Pharmaceutical Ingredient (API) and finished products (Stability Indicating Assay, Content Uniformity, Impurities/Degradants, Dissolution, Particle size, and Cleaning Validation) methods in order to meet and maintain compliance per current ICH and FDA guidance.Worked independently on high profile, complex projects, and out of specification (OOS) investigations, with minimal supervision.Scheduled and executed activities required for the Qualification of In-House Reference Standards to support laboratory operations and reduce costs associated with compendial standards. Performed method comparison, USP/PF evaluations, method transfer testing from different originating sites (for example, AR&D and Contract Laboratory) and made recommendations for implementation of proposed methods.Trained new scientists within the department on proper laboratory techniques and for successful and productive integration into the LTS team. Also trained chemists at the Puerto Rico site to ensure method transfers were successful and completed by the deadlines. Audited data and information for validation projects conducted at contract laboratories and at other site laboratories for thorough documentation, reporting of all test results and to ensure accuracy of calculations reported. Ordered and maintained departmental supplies, established a schedule for replacing HPLC lamps and executed those activities, and for proper maintenance of instruments within the LTS area.

Performed Assay, Content Uniformity, Dissolution, Identification and Impurities testing for finished product release and stability samples. Performed Assay, Impurities, Loss on Drying, Heavy Metals, Potentiometeric Titrations, Colorometric Titrations, Identification, Physical tests, Particle Size, Water Determination, Tapped Density and UV test for raw materials.

B. S., Chemistry

Bsc, Chemistry