associate director analytical development resume example with 20+ years of experience
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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.
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- Analytical development strategies for pharmaceutical products from Kick-off to close-out
- Preparation of drug development reports to summarize the findings into a concise evaluation and mitigation strategies
- Oversea analytical method development and validation activities for pharmaceutical products.
- Planning and oversee execution of analytical development and validation activities for raw materials (active and inactive), in-process materials, and finished dosage forms like Tablets, Capsules (IR, DR, ER), Oral Solutions, lotions, Ointments, Gels, Creams, and Shampoos as per USFDA, ICH guidelines and CDER requirements
- Oversee review and approval of drug development reports, method validation protocols and reports.
- Writing and/ reviewing CMC quality-technical documents in line with current USFDA Regulations, and based on the RTR (Refuse-to-Receive) Standards.
- Managing of analytical outsourcing operations at third party site(s)
- Participating in the preparation and management of regulatory agency inspections
- Interaction with DMF holders for method transfers and DMF related issues
- Design, evaluation and monitoring of stability Programs for drug substances and drug products, post approval stability requirements and statistical analysis
- Oversee qualification and evaluation of API vendors
- Physico-chemical characterization of pharmaceutical products including APIs, impurities
- Identification of unknown impurities (structure elucidation)
- Applying Quality by Design (QbD) principles in analytical product development
- Setting up of the GMP compliant labs
- Life-Cycle management of pharmaceutical products for ANDA (505j) and NDA (505b2) applications
- Responsible for Quality Control activities, including preparation and authorization of specifications, providing sampling instructions, test methods and other Quality Control procedures, analytical testing to support release or rejection of intermediate, bulk and finished products by Quality Assurance.
- Responsible for maintaining data Integrity to reduce incidents in Laboratory.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
- Method Development for various Raw materials, Intermediates and Finished products of different Drug substances Synthesized at R&D and Drug products like Tablets, capsules, Gels, Creams, Ointments, Lotions, Shampoos, Oral solutions.
- Method Development for Related Compounds, Assay, Dissolution, CU, Residual solvents, PSD, XRD, Blend Uniformity.
- Analytical method validations as per USFDA, ICH guide lines and CDER requirements
- Method Validation for Related Compounds, Assay, Dissolution, CU, Residual solvents, PSD, XRD, Blend Uniformity
- Preparing Method development reports, Method validation protocols and Reports.
- Writing CMC Quality-Technical documents in line with current USFDA Regulations
- Responding to ANDA queries related to CMC,DRLs, IRs, CRs received from USFDA
- Reverse engineering (De-formulation) and Diffusion studies
- Investigation of Laboratory deviations, OOS and technical complaints.
- Design, evaluation, Monitoring of stability Programs for drug substances, drug products. Post approval stability requirements and statistical evaluation of data for both drug substance and drug product
- Developed monograph methods for Related Compounds, Assay and Dissolution.
- Prepared protocols and coordinated in installation qualification of equipment.
- Prepared testing protocols for Reference standard samples and coordinate in testing.
- Compiled study summary reports for Reference Standard analysis.
- Prepared and maintained calibration records for the instruments.
- Addressed and thoroughly investigated general technical complaints.
- Prepared protocols and supporting documents (analytical workbooks, formats, etc.) for validations and stability programs
- Performed review activities such as review of analytical methods, protocols and analytical work records.
- Performed Analytical Method Development for different drug substances.
- Designed and carried out Method Validations as per Pharmacopoeias references for new test procedures
- Developed Calibration procedures for new instruments traceable to national/ international standards. Carried out the calibrations as per schedule.
- Designed, evaluated and monitored Continued Suitability Testing for Reference Standards.
- Method Development for various Raw materials, Intermediates and Finished products of different Drug substances Synthesized at R&D..
- Method Development for Related Compounds, Assay, Residual solvents, PSD and XRD.
- Analytical method validations as per USFDA, ICH guide lines and CDER requirements
- Method Validation for Related Compounds, Assay, Residual solvents, PSD and XRD.
- Preparing Method development reports, Method validation protocols and Reports.
Jawaharlal Nehru Technological University (JNTU) - Hyderabad, India,
Andhra University - India,
Andhra University - India,
- Received Lightening award (highest recognition) from United States Pharmacopeia (USP).
- Reviewed about 50 research articles from reputed journals in the analytical field -Acta chromatographica, American Journal of analytical chemistry, Global journal of analytical chemistry, Journal of Liquid chromatography etc.
- Responsible for Analytical operations for about 80 API molecules and 50 Pharmaceutical products.
- Responsible and oversee about 600 analytical method validations.
- Developed analytical methods and carried out structure elucidation for various drug substances, their intermediates and raw materials using various instrumental, classical and hyphenated techniques.
- Has taken an active part in 9 U.S.F.D.A inspections.
- Supported for more than 50 DMFs and ANDA submissions.
- Has taken an active part in the ISO-9001-2000 inspection.
- Has taken an active part in the ISO-17025 Lab accreditation.
Publications
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 Claire, James merecek Chromatographia Volume 80, Isssue 10, PP 1575-158 8, October 2017 DOI 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. Jessica D, Raghuram P, and Harikrishna KA Journal 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, Claire 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, Claire 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,
2009 DOI 10.1365/s10337-009-1185-x
6) 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/s10337-009-1145-5 7) Validated Chiral LC Method for the Enantiomeric Separation of Palonosetron Hydrochloride. P. Radhakrishnanand, D. V. Subbarao and V. Himabindu Chromatographia, Volume 69, page 369, 2009 8) 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/s10337-009-1083-29) 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, 2008
14) 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, 200815) 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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Resume Overview
School Attended
- Jawaharlal Nehru Technological University (JNTU)
- Andhra University
- Andhra University
Job Titles Held:
- Associate Director, Analytical Development
- Sr Scientist
- Scientist
- Jr. Manager
Degrees
- Doctor of Philosophy
- Masters of Science
- Bachelors of Science
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