Post on 16-Jan-2017
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.