Quality Assurance Development

HARDIK RANA Research Scientist (Analytical R&D)

*** ******* ***., **********, ** 11801 • Cell: 516-***-**** • Email: ************@*****.***

Professional Link: http://www.linkedin.com/in/hardikrana

CAREER OBJECTIVE

An experienced Analytical Scientist with a strong background in method development and quality control focusing on developing innovative products with quality, accuracy and dedication.

PROFESSIONAL SUMMARY

Dynamic, Visionary, Hardworking team player with more than 7 years of experience in biotechnology & pharmaceutical company. Combining extensive technical, analytical and interpretive skills with practical laboratory experience. Possesses strong interpersonal skills: vast experience working with multi-disciplinary research/scientific teams and professionals. Very thorough and detail oriented in basic research, documentation and all testing in cGMP Environments. Areas of experience include:

• Analytical Method Development/ Validation/Transfer • Project management skill

• Efficient coordinator of CRO’s/CMO’s • OOT, OOS, CAPA Investigations and reports.

• Good working experience with ANDA, NDA, IND Projects • cGMP, GLP, USP/NF, BP, JP, ICH, FDA

• Experience, understanding and good knowledge of working with different formulation types like Tablets, Granules, Capsules, Softgels, Suspension, Liquids, Injectable and Patches.

• Operational knowledge of sophisticated Analytical Instruments like GC, UPLC, UHPLC, HPLC, Dissolution (USP I, II, III), LC-MS, DSC, IC, UV-VIS, FT-IR, Particle Size Analyzer, Wet analysis pH, Titration, LOD, KF

• Operational knowledge of Instruments software like Waters (millennium and Empower), Shimadzu (EZ- Chrome), Agilent (Citrix/Chemstation), Dionex (Chromeleon), Perkin – Elmer (Turbochrom), LIMS, My SAP

• Conduct risk analysis in all aspects of method development to efficiently develop robust methods that are GMP friendly based on quality by design (QbD).

• Write/Review/Prepare SOP’s, Development Reports, Analytical Method Validation/ Method Transfer/Stability Protocol/Report compliance with ICH and FDA guidelines and regularities requirements.

• Good experience to handle Internal QA/FDA audits/Inspection like general cGMP and finish product pre-approval related audits.

PROFESSIONAL EXPERIENCE

ENDO Pharmaceuticals Inc., Westbury, NY, USA

Staff Scientist (Analytical Development Lab) June 2010 to till date

• Analytical Method Development/Validation/Transfer of various analytical methods like Assay, Related substance, CU/BU, Dissolution, residual solvent, cleaning method under GMP/GLP complies and Working as per Quality by Design Attribute. Actively involve to investigation of OOS, CAPA’s, OOT etc.,

• Write/Review/Prepare SOP’s, Research Reports, Protocol and Report of Analytical Method Validation/ Method Transfer as per compliance with ICH and FDA guidelines and regularities requirements. Working closely with CMO and CRO to get work done in timely manner.

• Good Experience in designing Protocols, Reports and Execution of In-vitro Bioequivalence study for finish products as per FDA guidelines. Good experience to handle FDA audits/Inspection like general cGMP and finish product pre-approval related audits.

• Administrator responsibility for Agilent HPLC with ECM (Citrix), Report Developer for OLIR (Agilent) and Laboratory LIMS Administrator.

• Identify critical in-process-control issues and develop appropriate Analytical methods

• Support development of formulations involving a variety of dosage forms including immediate and controlled/sustained release dosage forms

• Effective Project management skill to handle from early stage project to scale-up final stage. Experience to manage multi projects in same time without delay timeline.

QS Pharma, LLC. Boothwyn, PA, USA

Analytical Scientist II (Analytical Development Lab) November 2008 to June 2010

• Performed Analytical method Development/Validation/Transfer of various analytical method like Assay, Related substance, CU/BU, Dissolution, Residual Solvent, Cleaning method for Phase I. II and III NDA projects

• Toxicology formulation Analysis like Concentration verification, Stability and homogeneity for Clinical study under GLP phase inspection.

• Support analysis for pre-formulation study. Design stability studies for drug substance and drug product

• Cleaning Method development and Validation for GMP equipments.

• Work directly with counterparts in other areas of Pharm R&D as well as potentially Non-clinical development, Process Development and Quality Assurance.

Cadila pharmaceuticals/ Alembic Research Center Gujarat, India

Analytical Research Associate (Analytical Development Lab- F&D) May 2005 to July 2008

• Development of various analytical methods of finish products including Assay/Impurity method, Dissolution method, Residual solvent method.

• Analysis of raw materials, stability sample, compatibility study samples, in process, finished products and analytical sample under GMP environment.

• Troubleshooting and planning to solve problem related Lab, Development, In process product, and Lab instruments.

• Calibration of sophisticated Analytical Instruments like HPLC, Dissolution etc.,

• Preparation, review and implementation of Standard Operating Procedures for analytical laboratory under GLP/GMP guidelines.

EDUCATION BACKGROUNG

MS, Chemistry (Material Science) Sarder Patel University, V.V.Nager, Gujarat, India (2005)

Project Thesis Title: “ Improve softening point of Cole-Tar pitch using different Binder and filler for carbon-carbon composite”.

Project Advisor: Dr. S.M Manocha

BS, Chemistry, Gujarat University, Ahmedabad, Gujarat, India (2003)

Diploma in Information Technology, (D.I.T), Gujarat I.T.I, Gujarat, India (2000)

Diploma in Hardwar and Networking, (D.H.N), Gujarat I.T.I, Gujarat, India (2001)

OTHER SKILLS

• Good ability to work successfully in both team/matrix environments that gives me strength to work in a fast paced environment, manage priorities and maintain timelines for multiple projects.

• Excellent written and verbal communication skills

• Excellent management skill like managing chemist, Distributing work, Performance review

REFERENCES

Personal and Professional References will be available upon request.

Contact this candidate