Jayeshkumar Patel Email & Phone Number

Rocky Hill, Ct, Us

New Haven, Connecticut, United States

- Overseeing analytical testing by CMOs and CROs for small molecule, oligoneucliotide and peptide candidates for raw materials; assess assay performance, support stability set down, trending and data management.- Supporting the specification and shelf life setting for synthetic molecule candidates.- Overseeing analytical method development, phase appropriate validation, and transfer for synthetic molecule candidates- Overseeing API, DP, and raw material impurity characterization and control strategy setting, risk assesments. - Participating in CMO weekly meetings/teleconferences as Analytical representative providing technical support.- Reviewing analytical development/validation reports, stability protocols and Certificates of Analysis supporting release activities for API and DP. - Providing technical content for regulatory submissions with respect to analytical methods, stability studies and specification.- Addressing comments from regulatory agencies regarding analytical methods, stability and specification- Working with global regulatory team for drafting sections for CTD for multiple countries. - Providing subject matter expertise for regulatory interactions including inspections and audits.

• Manage a team of analytical scientists to achieve project goals.• Responsible for leading multiple projects simultaneously and tracking the progress of the project so that it remains on-time and within expected budgets.• Co-author and review GMP batch records, analytical methods, deviation, protocols, validation reports and other technical documents. • Training and onboarding new hires within the team and annual performance review and daily assignment of team members. • Design and execution of analytical experiments, acting as subject matter expert to client to achieve project goals.• Draw conclusions and design follow-on experiments based on multidisciplinary data.• Review and update documents related to regulatory submission for IND/NDAs.• Provide technical input for the resolution of investigations, deviations, out-of-specifications/out-of-trends (OOS/OOT), change controls, and CAPAs• Characterization and testing of non-monograph APIs and reference standards and analytical study designing of early clinical phase drugs.• Designing specification limits for release of raw materials, intermediates and finished products.• Review of GMP documents, change controls and regulatory documents pertaining analytical.• Coordination with clients regarding critical updates, changes and other requirements regarding projects.

Albany, New York, United States

• Analytical method development validation for solid and injectable DP dosage forms (extended release suspensions, liquids and lyophilized suspension).• Support pharmaceutical product development and analytical input for CMC technical document writing. • Perform force degradation studies to support product development and stability indicating method development.• Support analytical tech transfer to and from clinical site (and/or client site). • Discriminating dissolution method development for formulation development, RLD comparison. • Development of analytical methods for various attributes of product such as Assay, impurities, dissolution, particle size, water content. • Stability trending and shelf life extension evaluation.• Analytical testing of samples for QC release, stability study, process validation and cleaning validation. • Development of methods for APIs and drug products of early clinical phase.• Working with highly potent compounds and control substances in the GMP environment.

Baltimore, Maryland, United States

• Analytical development of methods to support CMC development and supplement data for ANDA filing.• Execution of protocol for method validation, method verification.• Preparation of protocols and test procedures accordance with SOPs and specification limits.• Design and preparation of test method procedures for new products as per development data and validation studies.• Characterization of new raw materials, perform stress studies and pre-formulation studies on new product formulations.• Review of chemist notebooks and documents as per GMP guidelines.• Maintaining work schedule and work priorities for junior chemists. Training and development of new hires.• Planning Analytical laboratory sample release in given timeline for clearance of production as well as to clients.• Identifying required changes in laboratory and raising change control for effective GMP.• Identifying significant change in stability results, investigation of OOS, OOT results and determination of root cause and ensuring CAPA is implemented.• Conducting Risk assessment and implementation of CAPA in analytical laboratory.• Involvement in each step of analytical method development and with proper strategy to ensure method is stability indicating.• Development and validation of chromatography methods of raw materials, residual solvents, intermediates.• Creating validation protocol for new method and verification of existing pharmacopeia method.• Ensure effective implementation of GMP and 21CFR part 210 and 211 by maintaining logbooks and instrument maintenance records.

Baltimore, Maryland, United States

• Execute complete QC testing of raw material, in process, finished product and stability samples with in accordance with cGMP and GLP.• Responsible to manage quality control activates including coordinating with different departments to ensure testing is completed within timeline.• Analyzing of samples for various quality attributes like Assay, Dissolution, impurities and residual solvents etc.• Analyzing physical properties (Description, viscosity, density, particle size, moisture) of samples.• Responsible to oversee calibration and maintenance program of HPLC, GC, dissolution apparatus, UV Visible spectrophotometer, polarimeter, pH meter and Analytical Balance.• Sample preparation for Method Validation studies as per guidelines.• Interpret results of laboratory findings and assess risks involved in new products• Maintain laboratory instrumentation, logbooks, test results, databases and notebooks in compliance with laboratory SOPs and cGMP as they relate to the Laboratory.

Master Of Science (Ms), Chemistry

Pharmaceutical analysis, Physical Organic Chemistry, Chemical Kinetics, Medicinal Chemistry, Instrumental Analysis, Pharmacokinetics.

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Sciences