Sreekanth Narravula
Budd Lake
Summary
Formulation development specialist with expertise in oral solids and injections for ANDA submissions. Skilled in regulatory compliance and project management, utilizing quality by design principles to enhance processes. Experienced in technology transfer and cross-functional collaboration, driving timely delivery of high-quality pharmaceutical products.
Overview
22
22
years of professional experience
Work History
Manager - Formulation Department
RiconPharma LLC
Denville
08.2022 - Current
- Developed formulations for oral solid dosage forms targeting the US regulatory market and pharmaceutical industry while adhering to company rules, regulations, and active SOPs and cGMPs.
- Optimizing formulation with respect to composition, important process parameters for achieving desired Target product profile.
- Based on formulation optimization studies, deriving a formulation meeting Target Product Profile.
- Providing pre-formulation, formulation, and pharmaceutics principles required to achieve bioequivalence of the drug product.
- Executing experiments to support the development of solid oral dosage forms and maintained formulation development lab notebooks.
- Designing and executing experiments, employing quality by design (QbD) principles.
- Supporting the technology transfer of formulation and process from the development site to manufacturing site.
- Coordinated with Quality Control, Quality Assurance, Production, and Regulatory Affairs to ensure compliance and streamline processes.
- Conducted literature searches and pre-formulation studies to support formulation development.
- Reviewed and analyzed patents to identify technical approaches for ANDA product development, ensuring adherence to innovator patents.
- Preparing chemistry-manufacturing control (CMC) documents (PDR/QOS, etc.) for regulatory submissions/ANDA filings.
- Preparing drug substance/in-process/finished product/stability specifications and its justifications as per US FDA/ICH guidelines.
- Performing reverse engineering in the development of pharma products.
- Applying chemical engineering principles in developing new products.
- Proficiently handling equipment like a high shear granulator, hot melt extruder, and fluid bed processor.
Assistant Manager
Ingenus Pharmaceuticals NJ, LLC
Fairfield
08.2019 - 08.2022
- Developed project plans and timelines, managed team efforts, and tracked milestones to ensure project deliverables were met on schedule.
- Develop project planning, timelines and logistical programs to match new product launches, contract manufacturing projects and process changes that are required for life cycle management of existing products.
- Transferred technology for new products from development or other sites to manufacturing site, ensuring seamless integration and operational readiness.
- Transferred technology to the manufacturing department during the process validation of submitted and approved products.
- Plan and manage successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit/ Registration for ANDA submission, component changes and process validation batches.
- Commercialized approved products through strategic planning and execution.
- Work closely with management for new products in pipeline.
- Managed all documentation for activities including writing and approving Standard Operating Procedures, CMC documents, and regulatory submissions.
- Assisted regulatory affairs department in regulatory submissions.
- Coordinated with Production, Quality Control, Quality Assurance, Engineering, and Regulatory Affairs departments to facilitate smooth departmental operations.
- Reviewed and updated standard operating procedures to ensure compliance.
- Designing and executing experiments by implementation of Quality by Design (QbDs) principle for new and existing products.
- Preparation and evaluation of Nitrosamine impurities and Elemental impurities in Drug substances/drug products.
- Troubleshooting of the commercial products.
- Process improvement and Quality improvement of approved commercial products.
- Initiation of stability studies for formulated trials, monitoring the study, compiling & analyzing the data.
- Identified new equipment and coordinated its installation and qualification.
- Process improvement and Quality improvement of approved commercial products.
Principal Scientist - I
RiconPharma India Pvt Ltd
Hyderabad
07.2016 - 08.2019
- Formulation Research and Product Development activities of Generic Specialty Formulations of Immediate release tablets, Extended-Release tablets, Osmotic drug delivery systems, Delayed release oral solid dosage forms, solutions, suspensions, Capsules and ointments.
- Developed products adhering to QbD principles while ensuring compliance with regulatory requirements.
- Delivering of robust, patent non-infringing and stabilized formulations as per agreed timelines.
- Led the team, designed experiments, and monitored experimental trials.
- Established product development timelines through collaboration with management team.
- Coordinated with cross-functional departments and contract manufacturing sites to secure timely availability of resources and materials for efficient execution of filing batches.
- Involvement in manufacture of scale-up, exhibit and validation batches.
- Technical evaluation of drug substance suppliers identified by the sourcing team.
- Review/analysis of patents and development of patent non-infringement dosage forms.
- Review and approval of product development reports.
- Review and approval of Process Evaluation Protocols, Batch Production Records, Hold Time Study Protocols, Exhibit Batch Master Production Records and Validation/Exhibit batch summary reports.
- Preparation of drug substance/in-process/finished product/stability specifications & its justifications as per US FDA / ICH guidelines.
- Preparation and evaluation of Scored tablets /Split tablets as per FDA guidelines.
- Preparation and evaluation of Nitrosamine impurities and Elemental impurities in Drug substances/drug products.
- Finalization of Exhibit batch sizes and commercial batch sizes based on the annual volumes forecast.
- Ensuring compliance of formulation development laboratory.
- Supporting Regulatory Affairs department by providing documents for dossier filings.
- Supporting Regulatory teams in addressing the deficiencies related to products.
- Ensuring approval and closure of any Incidental Deviations/Change Controls related to exhibit batch and commercial validation batches with adequate justification as per the time lines.
- Responsible for Qualification of laboratory equipments and instruments (Design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ) and Process qualification (PQ) as part of the team and SOP preparation for operation, cleaning and calibration.
- Has hands on experience of equipment handling like high shear granulator, hot melt extruder, fluid bed processor (GPCG), Bilayer compression machine, Capsule filling machine, Coating Machine, Laser drill machine and Printing machine.
- Has hands on experience of equipment handling like high shear granulator, hot melt extruder, fluid bed processor (GPCG), Bilayer compression machine, Capsule filling machine, Coating Machine, Laser drill machine and Printing machine.
Senior Manager
J.B. Chemicals and Pharmaceuticals Pvt Ltd
Thane
03.2015 - 06.2016
- Supported technology transfer of formulation and process from development to manufacturing, ensuring alignment with regulatory standards.
- Coordinated with Quality Control, Quality Assurance, Engineering, and Regulatory Affairs to streamline project workflows and enhance cross-department collaboration.
- Conducted formulation feasibility and process optimization studies, prepared pilot batch documentation, and secured raw material availability for efficient project execution.
- Optimizing formulation with respect to composition, important process parameters for achieving desired Target product profile.
- Based on formulation optimization studies, deriving a formulation meeting Target Product Profile.
- Prepared chemistry-manufacturing control (CMC) documents (MFR/BMR/PDR/QOS, etc.) for regulatory submissions and ANDA filings.
- Designing and executing experiments, employing quality by design (QbD) principles.
- Designing feasibility, strategy and proof of concept for new projects.
- Developed formulations for oral solid dosage forms and ointments for the US regulatory market.
Deputy General Manager
Omgene Life Sciences
Vadodara
03.2013 - 03.2015
- Facilitated technology transfer of formulation and process from development to manufacturing, ensuring alignment with regulatory requirements.
- Preparing chemistry-manufacturing control (CMC) documents (PDR/QOS, etc.) for regulatory submissions/ANDA filings.
- Optimized formulation composition and process parameters to meet desired Target Product Profile, enhancing product quality.
- Developed formulations for oral solid dosage forms and injections for the US regulatory market.
- Designing and executing experiments, employing quality by design (QbD) principles.
- Developed drug substance, in-process, finished product, and stability specifications with justifications according to US FDA and ICH guidelines.
- Coordinated with Quality Control, Quality Assurance, Engineering, and Regulatory Affairs to streamline cross-departmental collaboration.
Senior Research Scientist
Ranbaxy Laboratories Limited
Gurgaon
12.2010 - 03.2013
- Developed formulations for extended-release oral solid dosage forms for US regulatory market and pharmaceutical industry, ensuring compliance with company regulations, active SOPs, and cGMPs.
- Designing and executing experiments, employing quality by design (QbD) principles.
- Preparing drug substance/in-process/finished product/stability specifications and its justifications as per US FDA/ICH guidelines.
- Preparing chemistry-manufacturing control (CMC) documents (PDR/QOS, etc.) for regulatory submissions/ANDA filings.
- Optimizing formulation with respect to composition, important process parameters for achieving desired Target product profile.
- Based on formulation optimization studies, deriving a formulation meeting Target Product Profile.
- Conducted formulation feasibility and process optimization studies, prepared pilot batch documentation, and secured availability of raw materials for production readiness.
Research Executive
Sun Pharma Industries Limited
Vadodara
10.2005 - 11.2010
- Developed formulation for oral solid dosage forms targeting the US regulatory market.
- Facilitated technology transfer of formulation and process from development site to manufacturing site, ensuring compliance with regulatory standards.
- Optimizing formulation with respect to composition, process parameters for achieving the desired Target product profile.
- Designing and executing experiments, employing quality by design (QbD) principles.
Research Associate
Astron Research Limited
Ahmedabad
01.2004 - 10.2005
- Developed formulations for oral solid dosage forms tailored for European market requirements.
- Supporting the technology transfer of formulation and process from the development site to manufacturing site.
- Conducted literature reviews to support ongoing research projects.
- Assisted in designing and implementing experiments for data collection.
- Analyzed research data using statistical software and methodologies.
Education
M Pharmacy - Pharmaceutics
The Tamilnadu Dr. M.G.R Medical University
Chennai01-2003
B Pharmacy - Pharmacy
Gulbarga University
Gulbarga, India01-1999
Skills
- Formulation development
- Pre-IND submissions
- Regulatory compliance
- Quality by design
- Chemistry-manufacturing control
- Process optimization
- Technology transfer
- Project management
Publications
- Investigation on the impact of core and barrier layer composition on the drug release from a triple layer tablet., International Journal of pharmaceutical sciences and research, Vol. 3(7), 2012, Pg.:2168 -2179
- Compatibility studies between Ofloxacin and tablet Excipients through Differential Scanning Calorimetry., International Journal of Pharmaceutical Excipients, Vol.1, No.3, October - December 2002, Pg. 97-202
- Studies on Preformulation Compatibility between Lomifloxacin and tablet Excipients through DSC and X-Ray diffraction analysis., International Journal of Pharmaceutical Excipients, Vol. 2 No.2, April-June 2003, Pg.38-49
- Compatibility Studies Between Pefloxacin and Tablet Excipients through Differential scanning Calorimetry., Indian Drugs, 40(4) April 2003, Pg. 219-222
- Compatibility studies between Sparfloxacin and tablet Excipients through Differential Scanning Calorimetry., Indian Drugs, 40(11) Nov’2003, Pg. 661-664
Patents
- Granted Patent, US9622979B2, US2015/0132378A1, Multilayered dosage form
- Applied Patent, US2011/0217373A1, Extended release Pharmaceutical compositions of Guanfacine Hydrochloride
- Applied Patent, US2014/0112995A1, Multi-Layered, Multiple Unit Pharmaceutical Compositions
Timeline
Manager - Formulation Department
RiconPharma LLC
08.2022 - Current
Assistant Manager
Ingenus Pharmaceuticals NJ, LLC
08.2019 - 08.2022
Principal Scientist - I
RiconPharma India Pvt Ltd
07.2016 - 08.2019
Senior Manager
J.B. Chemicals and Pharmaceuticals Pvt Ltd
03.2015 - 06.2016
Deputy General Manager
Omgene Life Sciences
03.2013 - 03.2015
Senior Research Scientist
Ranbaxy Laboratories Limited
12.2010 - 03.2013
Research Executive
Sun Pharma Industries Limited
10.2005 - 11.2010
Research Associate
Astron Research Limited
01.2004 - 10.2005
M Pharmacy - Pharmaceutics
The Tamilnadu Dr. M.G.R Medical University
B Pharmacy - Pharmacy
Gulbarga University