Responsible for supervising QC Scientists.Responsible for fostering the overall training and development of Quality Control Scientists.Generates reviews and approves Certificates of Analysis, specification, SOP’s, test methods, incident reports,deviations, investigations and change controls.Generates, reviews and approves validation and stability protocols and reports.Performs routine QC testing, including HPLC and GC Analysis for raw materials, intermediates, stability testing and product release.Performs analytical method development and validation. Performs method troubleshooting as required.Acts as Empower administrator for QC analytical data system.

Samples raw materials as per specifications.Performs routine QC testing, including HPLC and GC Analysis for raw materials, intermediates, stability testing and product release.Performs analytical method development and validation. Performs method troubleshooting as required.Generates SOPs, test methods, deviations, investigations, change controls and certificate of analysis.Review analytical data.Acts as Empower administrator for QC analytical data system.Supports continuous improvement of the Quality Control GMP systems and Phyton Biotech’s Quality Systems.Authorized to approve specifications, SOPs, deviations, investigations, change controls and Certificates of Analysis.Acting Fire Marshall for Phyton Biotech.

Managed day-to-day operations of Quality Control group, including recruitment of new personnel, training and retention of team members. Maintains accurate and current records for all work activities.Managed and scheduled in-process component and final product testing to support the Manufacturing schedule.Prioritized inspection and testing of incoming materials.Participated in the development and improvement of processes, validation / test / inspection methods, materials and products under the guidance of Quality Manager and in cooperation with other departments.Initiated process variances, non-conformance reports, and corrective actions as assigned.Ensured timely completion and effectiveness of actions and followed up with other departments as required.Frequently interacted with functional peer groups, other company divisions or units, or customers.Ensured compliance with corporate quality standards and policies and performs all duties andresponsibilities as required by the Quality and Safety Manuals.

Responsible for developing, upgrading and qualifying/validating analytical methods in support of pre-clinical and clinical drugs.Developed and successfully qualified GC Headspace methods for residual solvents for various drug substances, using the Agilent GC 6890 with headspace autosampler 7694.Developed HPLC methods to provide analytical support to Preclinical, Manufacturing and Formulations GroupsWrote Qualification Protocols/Reports as well as the Analytical Testing Method (ATM) when required.Continued to test raw materials, bulk intermediate/finished products, research and development and stability samples under GMP guidelines.Responsible for implementing and maintaining Labware LIMSConfigured the LIMS system to capture and verify the testing data according to their specifications.Wrote Method Validation Protocols/Reports for validation of Labware LIMS methods.Initiated change controls for LIMS system when required.Supervised activities of junior personnel in the absence of Laboratory Manager.

Maintained and validated the Labware LIMS system for current and future use.Analyzed raw materials, bulk intermediate/finished products, and stability samples according to established protocols/procedures using various methods and instrumentation including Waters HPLC, Agilent GC, Karl Fischer titration, Malvern Zetasizer etc.Acted as a designate to the Team Leader/Supervisor.Trained junior analysts on instrumentation and quality systems

Performed release and stability GMP testing on commercial product(s) in a timely manner.Played a major role in implementing and validating a particle size testing method for Verteporfin for Injection (Visudyne) using the Malvern Zetasizer 3000HS.

Performed accelerated stability testing, using HPLC (HP 1100 & Varian units), spectrophotometer, dissolution and wet chemistry.Reviewed pilot scale manufacturing batch records.Aided with formulation work.Maintained and order lab reagent and supplies.Worked well within GMP guidelines.

Extracted vitamins A through E, cholesterol and total sugars from foods and beverages for GC and HPLC analysis.Operated and performed manual injections on GC and HPLC instruments.Trained other technicians in various sample preparations.Worked within ISO 9002 guidelines, as well as communicated with department heads and co-workers.

Ran the Agilent 5890 GC to identify microorganisms using MIDI Microbial Identification System (MIS) software.Performed validation testing on purified water for injection system, steam and dry heat sterilization ovens.Assisted in environmental monitoring of various departments, which involved taking surface and air samples, followed up by plate counts, identification and reports.