RESUME

RADHA KRISHNA. GOPI153 Hawthorne Avenue, Apt#204Central Islip NY 11722 Email: radhakrishna08@gmail.com Phone: (631)-682-4897

Career Objective

Seeking a challenging and responsible position in the field of pharmaceutical Organization. Where I can utilize my strong leadership, managerical and technical skills to make a significant contribution to company’s success and growth.

Total Experience: about 11.0 years in Analytical Research and development.

Skills and Strengths:

• Expertise in Analytical method development and validations as per USFDA guidelines for various types of formulations (tablets, capsules, injectables, creams and ointments) using HPLC and UPLC.

• Analytical Method development through Implementing QBD Aspects (QTPP, CQA, CMA&DOE) as per ICH Q8, Q9 and Q10 Guidelines.

• Characterization of crystalline material by using X-ray powder Diffraction.

• Having Good communication, interpersonal skills and presentation skills.

Current Position: January 2013 to present date:

Working as a Sr.Scientist in Analytical Research and development, Invagen Pharmaceuticals (A Cipla Subsidiary), New York.

• Analytical method development and validation of various types of formulations in compliance with ICH/FDA guidelines.

• Ensured that all lab operations meet all compliance and regulatory guidelines.

• Established regulatory specifications for drug substances, drug products and successfully filed numerous filings with the FDA.

• Built high quality standards in AR&D through new/revised SOPs and training in the department.

• Planning and distribution of works as per priority.

• Successfully filed several first to file ANDAs through quick turnaround time on lab activities.

• Organize and deliver effective, on time Analytical support to early formulation development and alternate source API.

• Carry out critical experiments and studies in support of regulatory submissions. Provide analytical methods, experimental data and reports to answer FDA deficiency letters.

• Provide guidance to the team members in scientific and cGMP matters to accomplish tasks that are scientifically sound and cost/time effective. Review and determine the acceptance of analytical work in terms of accuracy, consistency and integrity in compliance with FDA and ICH guidelines as well as company SOPs.

• Perform experiments and troubleshoot analytical problems for various issues encountered during a method life cycle.

• Review the Method Validation and Development Reports and protocols for a variety of scientific and regulatory purposes.

December 2009 to January 2013: Worked as a Jr.manager at DR.Reddys laboratories, bachupally, Hyderabad, India.

• Analytical Method development and Validation for quantification of Assay of drug products and their related impurities for various dosage forms like (Tablets, ophthalmic solutions and Capsules) by HPLC/UPLC and UV for US & Europe market.

• Development of stability indicating Related Substances method for the Formulation Drug products.

• Preparation of Standard Test Procedures, Method development summary reports, Validation Protocols and Validation summary reports for Dissolution, Assay and Related substance of drug products.

• Analytical Method Development through Implementing QBD Aspects (QTPP, CQA, CMA, DOE) as per ICH Q8, Q9, Q10 guideline.

• To ensure compliance of various quality measures and maintaining appropriate

requisite documentation records.

• Calibration and maintenance of laboratory equipments like (HPLC, UPLC, UV, Dissolution and Balance etc.)

December 2007 to December 2009: Worked as a Research Associate at Glenmark pharmaceuticals, mahape, Navi Mumbai, India.

• Analytical Method Validations for quantification of Assay of drug products and their related impurities for various dosage forms like (Tablets, creams ,ointments, ophthalmic solutions and Capsules) by HPLC/UPLC and UV for US & Europe market.

• Preparation of Standard Test Procedures, Method development summary reports, Validation Protocols and Validation summary reports for Dissolution, Assay and Related substance of drug products.

• To ensure compliance of various quality measures and maintaining appropriate requisite documentation records.

• Calibration and maintenance of laboratory equipments like (HPLC, UPLC, UV, Dissolution and Balance etc.)

June 2006 to December 2009: Worked as a Executive at Orchid Chemicals and pharmaceuticals, Ikkt, Chennai, India.

• Performed the Assay, Related compounds and Dissolution studies for Stability samples (Accelerated, Intermediate and long term conditions).

• To ensure compliance of various quality measures and maintaining appropriate requisite documentation records.

• Calibration and maintenance of laboratory equipments like (HPLC, UV, Dissolution and Balance etc.)

Calibration and operation of the following instruments:

• Waters Acquity UPLC system with Empower Software

• HPLC Waters (Alliance with Empower software, UV , PDA & RI Detectors)

• Shimadzu (LC- with Empower software)• Agilent (1100 & 1200 Series with LC solutions Software)

• Varian & Vankal USP-III and USP-IV dissolution apparatus.

• Lab India dissolution apparatus (USP-I and USP-II).

• Shimadzu UV/VISIBLE Spectrophotometer.

• X-Ray Diffractometre(D2 Phaser)

Education:

• Master of Sciences: M.SC Organic Chemistry, Andhra University Campus, Visakhapatnam, India. (June 2004-April 2006).

• Bachelor of sciences: B.SC, DRG Govt degree college, Andhra university, Tadepalligudem, India (June 2000 to April 2003).

Personal Details: Name : Radha Krishna .Gopi

Father’s Name : Sitaramayya Gopi

Date of Birth : 10 July 1983

Languages Known: English, Telugu and Hindi

Permanent Address : Radha Krishna .Gopi

H.No: 3-116, Pedatadepalli,

Tadepalli gudem, West Godavari District.

Andhra Pradesh-534101, India.