Development of New UV Spectrophotometric Method for Determination of Capecitabine (Anti-Cancer Drug) in Pharmaceutical Formulation.
Effect of Acetylcholine on the contraction of frog rectus abdominus muscle.
Professional Summary
Innovative, accomplished, results-oriented pharmaceutical professional with 2 years of progressive experience across a broad range of product development functions in the pharmaceutical industry. Proven ability to develop and manage multiple research programs with strong technical background in pre-formulation, formulation development, process development/ optimization and technology transfer. Business-savvy, motivated and energetic professional with strong leadership and presentation skills. Seeking a challenging position in the field of Regulatory Affairs that will utilize my pharmaceutical industry knowledge and experience to aid in the life cycle management of existing products and provide regulatory advice for bringing new products to market
Skills
Microsoft Office- Word, Power Point, Excel and Adobe Acrobat
*Good communication and technical writing skills
Work History
06/2015 to Present
Formulation ScientistCatalent Pharma Solutions, Inc. – Washington, DC,
Generics, IND and NDA- Parenteral, Oral and Topical product development in various therapeutic areas Pre-formulation and formulation development, process development, technology transfer and scale-up for sterile, oral and topical drug product(s) manufacturing Reviewed documents including SOPs, analytical procedures, validation and stability protocols and reports Participate in regulatory agency inspections such as PAI and cGMP inspections Read, review, interpret and keep current with regulations and publications regarding drug and device products with primary focus on pharmaceutical products Regulatory documentation such as product development reports (PDRs) and quality overall summary (QOS) for NDA and ANDA submissions and addressing the deficiencies on the submitted ANDA applications Review responses to FDA 483 observations Prepare, review and approve batch records for manufacturing of clinical trials materials In close collaboration with RA team and assemble all necessary regulatory CMC documents for all regulatory submissions (NDA/ ANDA/ Supplemental filings).
Negotiate with FDA and other government agencies to ensure product approvals and acceptance of submission strategies for developmental and commercial product.
06/2014 to 05/2015
Formulation ScientistCatalent Pharma Solutions, Inc. – Arizona, LA,
Write regulatory documents to support regulatory submissions Responsible for reviewing SOP's Review of batch records for release of clinical trials materials Ensure that employee files and training records relative to cGMPs are appropriately maintained Read, review, interpret and keep current with regulations and publications regarding drug and device products with primary focus on pharmaceutical products.
06/2013 to 08/2013
Bickford Senior Living – Oswego, , India
Responsible for dispensing medication to patients Responsible for counseling of patients on prescribed medication Providing information to the patient on the prescribed medicine Accountable for maintaining and checking inventory In charge for organizing the pharmacy store and communicating the material management during shortage of medicines.
05/2012 to 08/2012
Industrial TraineeThe Biome School – Saint Louis, , India
Monitored in-process equipment and machinery.
Assisted in manufacturing of tablets.
Assisted packaging department for filling/packaging of finished product.
01/2012 to 04/2012
Industrial TraineeDr. Reddy's Lab – City, , India
Successfully completed industrial training at Dr.
Reddy's Laboratories in Production, Quality Assurance, Quality control and Packaging.
Successfully completed a project in Quality Assurance department on 'The importance of Quality Assurance and its Practice.
10/2009 to 05/2013
Teaching AssistantSultan Ul Uloom College Of Pharmacy – , ,
Conducted workshops and seminars in mathematics, biology and chemistry.
Library and Academic Services.
Assisted in maintaining journals and course work books Assisted the professor with experiments at Pharmaceutical Lab.
Education
Expected in May 2015
Master of Science: Biotechnology Regulatory Affairs Johns Hopkins University - , GPA: Biotechnology Regulatory Affairs
Expected in
Bachelors: Pharmacy Sultan Ul Uloom College of Pharmacy - Hyderabad, GPA: Pharmacy
Expected in May 2013
B. Pharm: - , GPA:
Interests
Licensed Pharmacist from Andhra Pradesh, India
Pharmacy Council of India
Additional Information
CERTIFICATE/LICENSE
Licensed Pharmacist from Andhra Pradesh, India
Pharmacy Council of India
AWARDS AND HONORS
*Sultan Ul Uloom, College of Pharmacy Dean's list
*Sultan Ul Uloom, College of Pharmacy Sports Man of The Year (2012, 2013)
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