SRINIVASARAO TENTU
Zionsville
Summary
Dynamic Senior Manager with extensive experience at Inotiv Inc., excelling in analytical method development and regulatory compliance. Proven track record in leading cross-functional teams and mentoring scientists, while delivering innovative solutions in dissolution development. Adept at project management and scientific writing, ensuring high-quality outcomes in complex pharmaceutical environments.
Overview
21
21
years of professional experience
Work History
Senior Manager and Principal Investigator – Pharmaceutical
Inotiv Inc. (formerly BASi, Inc.)
West Lafayette
06.2018 - Current
- Working as a Principal investigator for assigned projects.
- Lead scientist for method development of DFA methods, In vitro BE studies and Dissolution method development.
- Trian scientists on method development.
- Handling of OOAc, OOT and investigations through electronic system (master control).
- Regular meetings and communications with clients and understanding client’s requirements.
- Writing, reviewing, and approving Scientific reports, validation protocols and analytical methods.
- Reviewing analytical data from validations and LTS sample analysis.
- Developing dissolution methods for different types of formulations (IR, ER, MR) for different types of dosage units (Tablets, Capsules, Suspensions, Powders, Ovules, suppositories, creams, chewable & dispersible tablets, etc..)
- Drug excipient compatibility studies for new molecules.
- Analytical method development of polysaccharides and oligonucleotides.
- Guiding peer scientists for the method development.
- Hands on experience with LC-MS for Bio analysis.
- Exposure on Method Development of Bio sample preparations.
- Using different softwares; Electronic Lab notebook, Watson, Chromeleon, PDS, Analyst, Dynamics AX, Smartsheet and ESM.
- Supervisor for work distribution, planning, scheduling analysts.
- Reviewing related standard operating procedures.
Senior Research Scientist-2
Akorn Pharma, Inc.
Vernon Hills
10.2017 - 06.2018
- Analytical Method Development for different types of formulations.
- Writing best practice documents for analytical method development.
- Handling regulatory queries for dissolution methods.
R&D Executive (Senior Associate Scientist)
Janssen Pharma, (Johnson & Johnson PVT Ltd.)
MH
08.2009 - 06.2017
- Dissolution method development for Dissolution methods for QC-Release & stability testing and their validations as per current guidelines and regulatory requirements.
- Analytical Method development and validation for Assay & Degradation Products (Related Substances) of active in different types of formulations for IND/CTA and NDA.
- Having exposure on different formulations like Tablets, Capsules, Injectable, Suppositories, Creams, Suspensions, Oral Solutions, beads and Ovules.
- Analytical methods assessment and remediation for EMEA, Canada and Japan regulated markets.
- Prediction of in-vivo performance of the drug using Gastroplus software based on physicochemical properties and in-vitro dissolutions.
- Start to end responsibility for Projects (Method development, Optimization with locked formulations, Method Validation and Method Transfers for Assay Active, Degradation Products, Dissolution Development, Content Uniformity, Preservatives & other analytical tests).
- Working on pre-formulation studies of new chemical entities in different phases.
- PBDT and Dissolution method development for PoC’s to support during formulation development at the early stage of different CMC stage gates.
- Exposure on Bio Dissolution Development by using dissolution apparatus, USP-I, USP-II, USP-III, USP-IV and USP-VII for different types of formulations and for all type of BCS class drugs during early phase.
- Writing development reports, validation protocols, investigational reports, white papers, regulatory reports, best practices documents and justification reports to submit to different Health Authorities.
- Actively coordinated with CROs for managing workload & meeting the project timelines.
- Applying QbD & DoE during Method development and investigations.
- LC-MS for unknown impurity mass determination on need basis.
- Exposure on handling of various queries from different Health Authorities for the post approval changes and life cycle management of the products.
- Electronic Lab notebook (eLN) for documentation.
- Exposure on different soft wares; eLN, ADMET predictor, Gastroplus, Compliance Wire & other softwares for general usage of instruments.
- People management, work plan and work distribution and management of heavy workload.
- Actively Participated in the USFDA, TGA, MHRA, EMA and other regulatory authorities.
- Following all the standard operating procedures, cGMP & CGLP and EHS guidelines related to assigned work.
- Developed analytical methods for Assay and impurities.
Junior Manager
DR Reddy’s Laboratories Ltd.
TL
09.2007 - 07.2009
- Analytical Method development for Assay of actives, degradation products, preservatives, antioxidants of Drug products by HPLC, UV, Titrimetric, IR techniques.
- Analytical method development for Dissolution technique for QC methods and for dissolution in Bio medias for IVIVC, BA, BE and clinical studies.
- Analytical method development for dissolution for all type of formulations (IR, DR, ER & MR) and for all BCS classes.
- Analytical development for different formulations like tablets, Capsules, powder for oral Suspensions, syrups and other formulations.
- Analytical method validation for Residual solvents by GC with headspace/liquid injection.
- Investigation of Analytical method related issues and drug product related issues.
- Having Exposure on work distribution, work monitoring and managing workload from Formulation Scientists.
- Preparation of protocols for all types of Analytical methods like Assay active, degradation products, Content uniformity, Dissolution for all type formulations.
- Bio Dissolution Development by using dissolution apparatus, USP-I, USP-II, USP-III & USP-IV for different types of formulations and for all type of BCS class drugs.
- Performed in-vitro studies to predict IVIVC for ANDA products.
- Multimedia Dissolution profiles, Comparison with innovator and f1&f2 calculations.
- Awareness and participation on Gamma-Scintigraphy technique for MR products in GI tract (INVIVO study).
- Good Exposure on different soft wares for the general usage of Analytical Instruments.
- Exposure on FTIR for quantification analysis.
Executive
Piramal Health Care PVT Ltd.
MP
11.2006 - 09.2007
- Performing Stability studies for different types of dosage forms like Tablets, capsules, ophthalmic solutions.
- Done validations of analytical methods for drug products as per ICH guidelines.
- Done method transfers from R & D Unit to plant.
Supervisor
Ranbaxy Laboratories Ltd.
MP
08.2004 - 11.2006
- Determination of water content in Drug products by Karl Fischer.
- Determination of viscosity, re-suspendability, deliverable volume for suspensions.
- Read and understand the in-house SOPs.
- Attended the trainings and seminars for method development and validations.
- Reading and understanding pharmacopeia like USP, EP and BP.
- Analysis of Stability samples for Assay of actives, preservatives, antioxidants & degradation products and dissolutions in different types of formulations like Tablets, capsules with powder / beads.
- Performed dissolution of oral dosage forms like Tablets, capsules, suspensions.
- Exposure on analysis of different types of dosage forms: like tablets, Capsules, powder for oral Suspensions, Injectables, syrups and other formulations.
- Calibration of instruments like KF apparatus, pH meters, Balances, dissolution apparatus, HPLC, UV spectrophotometers.
- Analysis of preservatives, antioxidants by titrimetric analysis.
- Understanding the ICH and FDA guidelines.
- Performed Content Uniformity for Drug Products by HPLC & UV instruments.
Education
Master of Science - Analytical Chemistry
Andhra University
Visakhapatnam, AP, India01.2004
Batchelor of Science - Chemistry, Physics and Math
01.2002
Skills
- People Management
- Method development
- Analytical techniques
- Regulatory compliance
- Scientific writing
- Project management
- Data analysis
- Team leadership
- Client communication
- Quality assurance
- Problem solving
- Attention to detail
- Time management
- Training and mentoring
- Cross-functional collaboration
- Resource allocation
- Cross-functional team coordination
- Cross-functional communication
- Multitasking
- Analytical skills
- Regulatory Queries
- Trainer
- Handling OOS
- Handling OOT
- Laboratory Investigations
- Deviations
- Dissolution Development
- Analytical Method Development
- Method Validations
- Method Transfers
- Life Cycle Management
- NME's
- SUPAC
- NDA
- MAA
- IND
- CMC
- ANDA
- Generic Drug Development
- CGMP
- GLP
- GSP
- PBDT
- PBPK Modeling
- Gastroplus Software
- IVIVC
- F1
- F2
- FDA
- EMEA
- Writing White Papers
- Problem resolution
- Decision-making
- Positive attitude
- Interpersonal skills
Honors And Achievements
- Got university first in Analytical chemistry (Masters), Andhra University, Vizag, India.
- Contributions to the successful EMEA audit were recognized with a reward and appreciation certificate at Janssen Pharmaceutical (companies of Johnson & Johnson Ltd.).
- Exposure on Gastroplus Software for evaluation of Insilco models from Invitro Dissolution data and PBPK data.
- Trained on 'PBDT for NCE projects at different phases from PoC’s to late phase' at Janssen Pharma, Beerse, Belgium for 6 months.
- Had exposure on doing successful investigation at China FDA lab, Xeon, China for China generic consistency program.
Professional Competencies
- People Management
- Answering regulatory queries
- Trainer
- Handling OOS, OOT, Laboratory Investigations, Deviations & CoC’s
- Dissolution Development
- Analytical Method development, method validations and method transfers
- Exposure on Life Cycle Management, NME’s and SUPAC
- NDA/MAA/IND and CMC
- ANDA/Generic drug Development
- Extensive cGMP, GLP and GSP work environment
- PBDT/PBPK modeling using Gastroplus software
- IVIVC/f1/f2
- Answering Regulatory queries (FDA/EMEA) and writing white papers
Timeline
Senior Manager and Principal Investigator – Pharmaceutical
Inotiv Inc. (formerly BASi, Inc.)
06.2018 - Current
Senior Research Scientist-2
Akorn Pharma, Inc.
10.2017 - 06.2018
R&D Executive (Senior Associate Scientist)
Janssen Pharma, (Johnson & Johnson PVT Ltd.)
08.2009 - 06.2017
Junior Manager
DR Reddy’s Laboratories Ltd.
09.2007 - 07.2009
Executive
Piramal Health Care PVT Ltd.
11.2006 - 09.2007
Supervisor
Ranbaxy Laboratories Ltd.
08.2004 - 11.2006
Master of Science - Analytical Chemistry
Andhra University
Batchelor of Science - Chemistry, Physics and Math
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