Ankita Patel Email & Phone Number

Franklin Township, Nj, Us

East Rutherford, New Jersey, Us

Highly experienced pharmaceutical research and development professional with expertise in analytical chemistry. Assay, Impurities, dissolution, disintegration testing with compliance requirements within Current Good Manufacturing Practices and FDA regulatory environments. Capable of handling multiple assignments under high pressure and consistently tight deadlines. Exhibits strong interpersonal and communication skills to foster relationship building. Takes the challenging, creative role of working in the field of Chemistry and implements the expertise of development and analysis of quality compounds efficaciously for the organization. Capable to take leadership schedule testing and release product in timely manner.

Whippany, New Jersey, Us

Group Lead/Analytical Scientist-III• Worked as team leader providing schedule to other chemist and organizing workflow within the timed framework for routine stability, process validation, submission, and clinical batches.• Keep tracking for the stability samples and schedule all required tests to complete the testing before the due dates.• Trained and supervised other analysts on analytical testing on various projects.• Provide and discussed all-necessary results with the client in timely manner.• Conducted a lead for any failure results within the group. Collected test data to identify the root cause, recommended corrective, preventive action.• Opened the OOS/OOT, and Deviation in Track wise system and collaborations. • Operated Novatek stability software to entered stability data and generated stability reports.• Preformed testing for validation, submission and clinical batches as per protocol requirements.• Worked on different dosage forms such as tablets, capsules, oral suspension and oral solutions on development stage.• Conducted Blend Uniformity, Stratified Content uniformity, Assay, Related substances, Dissolution profile, and Impurity testing using Waters/Agilent, system with Empower-3 software.

Hayward, Ca, Us

• Daily batch release and stability testing. Conduct testing for method and process validation samples.• Kept a good record of standard and samples for actives and impurities such as certificate of Analysis, MSDS and drug master file.• Learned troubleshooting on HPLC using technical skills.• Performed instrumental and operational qualification for analytical instruments like HPLC,ph meter, analytical balance.• Organized workflow within time framework to achieve good results.• Worked actively on FDA deficiency responses.• Documented, interpreted and reported test results within the scheduled time interval.• Tested raw material, In process and finished products accordance with standard procedures; performed distillation and physical testing.• Approved materials and products based on test results.• Collect and analyzes test data to identify root cause, draw conclusions and recommend actions• Participate in failure investigations to identify root cause, recommend corrective, preventing action and by block any out of specification product.• Routine QC wet chemistry and related documentation as per CGMP, USP and official pharmaceutical compendia.• Performed Stability Studies of development products.• Operated HPLC, UV/VIS Spectrophotometer• Followed SOPs, QCM and FDA regulations in a GMP regulated area.• Resolved Trouble shooting problem in HPLC.• Trouble shooting and calibration for analytical instruments.• Testing to support finished product development.• Testing of raw materials, in process, final product, stability and R &D samples by USP and in house method.• Review and audited test results.• Prepared and trained on different training module for new chemists.. Method Transfer, Method Validation Testing for Related substance, Assay Analysis and Cleaning Validation.

Ohm Laboratory, New Brunswick, NJ​ 2013- 2014Quality Control Chemist • Capable of handling multiple assignments high pressure and consistently meeting tight deadlines• Performed analysis of Stability samples.Kept new stability sample in the chambers as per protocols and pull out the stability sample as per schedule. Entering data in the stability software. • Dissolution and Disintegration testing as per USP requirements.• Daily batch release and stability testing. • Kept a good record of standard and samples for actives and impurities such as certificate of Analysis, MSDS and drug master file.• Learned troubleshooting on HPLC and UV-Vis Spectroscopy using technical skills.• Performed instrumental and operational qualification for analytical instruments like HPLC, pH meter, analytical balance.• Organized workflow within time framework to achieve good results.

Core Pharma LLC, Middlesex, NJ​ February 2006 – May 2013Quality Control Analytical Chemist• Documented, interpreted and reported test results within the scheduled time interval• Worked within the laboratory in a team environment; assisted with QC initiatives; actively participated in QC projects and team meetings• Tested raw material, In process and finished products accordance with standard procedures; performed distillation and physical testing.• Approved materials and products based on test results• Collect and analyzes test data to identify root cause, draw conclusions and recommend actions• Participate in failure investigations to identify root cause, recommend corrective, preventing action and by block any out of specification product.• Routine QC wet chemistry and related documentation as per CGMP, USP and official pharmaceutical compendia• Chemical testing such as Nitrate test, Heavy metal, Loss on Draying (LOD), Total organic contents (TOC), Thin Layer Chromatography(TLC).• Performed Potency Assays, Blend Conformity and Impurity testing on Raw materials, In-Process powder, Final mix and Finished Products.* Wet Lab Testing Such as Weight Variation, Water by Karl Fisher, Friability Testing, Moisture Analysis, Automatic Polari meter, UV Spectroscopy. • Providing assistance in laboratory housekeeping and updating laboratory supply inventories.• Performed Stability Studies of development products.• Operated HPLC, UV/VIS Spectrophotometer• Followed SOPs, QCM and FDA regulations in a GMP regulated area.• Performed Calibration of HPLC Instruments. Calibration of the other analytical equipment according to the NIST standard.• Resolved Trouble shooting problem in HPLC• Trouble shooting and calibration for analytical instruments.• Testing to support finished product development.