Quality minded professional with a focus on analytical strategy, planning, compliance and organizational goals. A committed professional who is knowledgeable, being productive, resourceful, with proven complex problem-solving ability; innovate and champion change to manage a highly effective analytical compliance team within the confines of the current organizational plan. A dynamic quality minded pharmaceutical professional with over 20 years of experience in development strategy for a broad range of analytical development and diversified product development with sound scientific principles and current regulatory requirements. Expertize in Physico-chemical characterization of active pharmaceutical ingredients and finished product characterization and evaluation. Experienced in Life cycle management (kick-off to close out) of complex products mainly for ANDA (505j) applications. Demonstrated working Knowledge of cGMP quality requirements for generic analytical development (including API) and working knowledge of FDA and ICH regulatory requirements and guidelines specific to the areas of API Quality. Working knowledge on Chemistry, Manufacturing and Controls (CMC) of pharmaceutical development, process development, process characterization, submission batches and post approval changes as per the US FDA, ICH and WHO requirements for different dosage forms including Tablets, Capsules, Gels, Creams, Ointments, Lotions, Shampoos and Oral solutions. Strong leader in pharmaceutical analytical research and development, resource optimization, project management; leading, coaching and training project teams. Leverage fundamental understanding of formulations, product development and material characterization to implement analytical methodologies as appropriate for various formulations and dosage forms. Demonstrated knowledge in setting up of the GMP complaint labs, chemical degradation concepts: Impurity profiling by LC-MS/MS, GC-MS/MS and ICP-MS. Expertise in complete physical and chemical characterization of raw materials/excipients/finished products, PXRD and morphology. Experience in handling analytical outsourcing operations at national and international vendors (CROs/CDMSs). New Product Launches, alternate API/excipient qualification, scale up/down, submission batches, technical transfers, process improvement projects, process validation and cleaning validations. A resilient leader engaged in scientific field with high energy and ability to influence and persuade others. Published more than 20+ research articles in reputed journals. Editorial member and peer reviewer of international Journals.
1) Development and Validation of a Novel Stability indicating UPLC Method for Analysis of Related Compounds and Assay of Bexarotene, An anti-Cancer agent. Venkata Subbarao Devarakonda, James merecek Chromatographia Volume 80, Isssue 10, PP 1575-1588, October 2017DOI 10.1007/s10337-017-3369-0
2) Development and Validation of a Novel Stability indicating UPLC Method for Dissolution analysis of Bexarotene Capsules-An anti-Cancer drug. Venkata Subba Rao D, Raghuram P, and Harikrishna KAJournal of Chromatography & Separation techniques, Volume 8, Issue 2, 1000364 2017, DOI: 10.4172/2157-7064.1000364
3) A validated stability-indicating LC method for fluocinonide in the presence of degradation products, its process-related impurities and identification of degradation products. Prabha Srinivasu, Devarakonda V. SubbaRao, Raju V.K. Vegesna, K. Sudhakar Babu American Journal of analytical chemistry- Volume 1, Issue 03, 30 Nov 2010, Pages 113
4) A validated stability-indicating LC method for acetazolamide in the presence of degradation products and its process related impurities.
Prabha Srinivasu, Devarakonda V. SubbaRao, Raju V.K. Vegesna, K.Sudhakar Babu Journal of Pharmaceutical and Biomedical Analysis, Volume 52, Issue 1, 1 May 2010, Pages 142-148
5) LC Separation of Para and Meta isomers of Zafirlukast in Bulk Drug Samples and Pharmaceutical Dosage forms using a Chiral Stationary phase.A.Madhavi, D. V. Subbarao, P.Srinivasu and A.Naidu Chromatographia Volume 70, Numbers 1-2 /July,
2009DOI 10.1365/s10337-009-1185-x6) Development and validation of a new LC Analytical method for the determination of Related components and assay of Ranolazine in Bulk drug and Pharmaceutical Dosage forms. A.Madhavi, D. V. Subbarao, P.Srinivasu and A.Naidu Chromatographia, Volume 70, Numbers 1-2 / July, 2009 DOI:10.1365/s10337-009-1145-57) Validated Chiral LC Method for the Enantiomeric Separation of Palonosetron Hydrochloride. P. Radhakrishnanand, D. V. Subbarao and V. Himabindu Chromatographia,Volume 69, page 369, 20098) Development and validation of a new LC Method for analysis of Brimonidine Tartrate and Related Components. A.Madhavi, A.Naidu, D. V. Subbarao and P.Srinivasu Chromatographia, Volume 69, page 1413-1419, April 2009 DOI:10.1365/s10337-009-1083-2
9) A Validated Chiral LC Method for enantiomeric separation of Sertraline Hydrochloride in Bulk drug and pharmaceutical dosage forms. P. Radhakrishnanand, D. V. Subbarao and V. Himabindu Analytical chemistry: An inidan journal Vol 7, Issue 7, 2008
10) A Validated LC Method for enantiomeric separation of Ezetamibe in Bulk drug and pharmaceutical dosage forms. P. Radhakrishnanand, D. V. Subbarao and V. Himabindu Indian drugs 46(4) APRIL 2009 page 315-322
11) A Validated Chiral LC Method for enantiomeric separation of Abacavir Key intermediate, ABC-3. P. Radhakrishnanand, D. V. Subbarao and V. Himabindu Analytical chemistry: An inidan journal Vol 7, Issue 8, 2008
12) A Stability indicating LC Method for Aripiprazole
D. V. Subbarao, Sateesh.K.Shetty, P. Radhakrishnanand,M.V.Suryanarayana Analytical chemistry:An inidan journal Vol 7 , Issue 7, 2008
13) A Validated LC Method for Determination of the Enantiomeric Purity of Montelukast Sodium in Bulk Drug Samples and Pharmaceutical Dosage Forms P.Radhakrishnanand, D. V. Subbarao, K. V. Surendranath, D.Subrahmanyam. V.Himabindu Chromatographia, Volume 68, Numbers 3-4 / August, 200814) A Validated LC Method for Determination of the Enantiomeric Purity of Darifenacin in Bulk Drug and Extended Release Tablets P. Radhakrishnanand, D. V. Subbarao and V. Himabindu Chromatographia,Volume 68, Numbers 11-12 / December, 2008
15) A Validated Chiral LC Method for the Separation and Quantification of ( S,R,S )-Enantiomer and ( R,R,R )-Isomer of Aprepitant.
P. Radhakrishnanand, D. V. Subbarao, K. V. Surendranath, D. Subrahmanyam and V. Himabindu Chromatographia, Volume 68, Numbers 7-8 / October, 2008
16) A Stability Indicating LC Method for Vardenafil HCl. D. V. Subbarao, K. V. Surendranath, P.Radhakrishnanand,M.V.Suryanarayana, P.Raghuram, Chromatographia, Volume 68, Numbers 9-10 / November, 2008
17) A Stability indicating LC method for Amtolmetin Guacyl. D. V. Subbarao, P. Radhakrishnanand, K. V. Surendranath, P. Raghuram, V. Himabindu Chromatographia, Volume 68, Numbers 7-8 / October, 2008
18) Stress Degradation Studies on Dutasteride and Development of a Stability-Indicating HPLC Assay Method for Bulk Drug and Pharmaceutical Dosage Form. D. V. Subbarao, P. Radhakrishnanand Chromatographia, Volume 67, Numbers 9-10 / May, 2008
19) Stress Degradation Studies on Tadalafil and Development of a Validated Stability-Indicating LC Assay for Bulk Drug and Pharmaceutical Dosage Form. D. V. Subbarao, P. Radhakrishnanand and V. Himabindu Chromatographia, Volume 67, Numbers 1-2 / January, 2008
20) A Stability-Indicating LC Method for Candesartan Cilexetil D. V. Subbarao, P. Radhakrishnanand, M. V. Suryanarayana and V. Himabindu Chromatographia, Volume 66, Numbers 7-8 / October, 2007
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