Summary
Overview
Work History
Education
Skills
Awards
Timeline
Generic
Shashank Nagubothu

Shashank Nagubothu

Formulation Research and Development
Bengaluru

Summary

A Pharmaceutical professional with proven ability as Formulation research and development scientist. Experience in development of various dosage forms like Injectable [Suspensions, Lyophilization, Prefilled Syringes, Liquid etc.,], Solids [Tablets, Capsules, Pellets etc.], using Quality-by-Design (QbD) concepts for US, Europe, China and other regulatory markets. Proven ability to develop with strong technical background in pre-formulation, formulation development, process development/ optimization and technology transfer. Professional with strong background in leadership and team management, adept at driving projects to successful completion. Known for fostering collaborative environments and consistently meeting organizational goals. Demonstrates flexibility and reliability in dynamic work settings. Skilled in conflict resolution, strategic planning, and performance optimization.

Overview

12
12
years of professional experience

Work History

Senior Team Leader

Mylan Laboratories Limited
03.2023 - Current
  • Performing a literature survey to gather patents and published articles on the projects, and coordinating with IPR in evaluating the patent claims.
  • Identifying available vendors for the required raw materials, and coordinating with sourcing for timely procurement of materials.
  • Involved in the entire drug product development process, starting from the procurement of raw materials, pre-formulation studies, lab-scale studies, optimization batches, submission batches, up to the manufacturing process transfer to production, as per the regulatory requirement.
  • To interpret analytical data to further develop and optimize formulations and manufacturing processes.
  • Development of injectable formulations, and successful scale-up to pilot batches.
  • Providing inputs for the preparation of finished product specifications, raw materials specifications, master formula records, intended batch manufacturing records, etc.
  • Preparation of QbD documentation, like 32PP PDR, is required for the filing of the developed product with various regulatory agencies, such as the US, Europe, Canada, Australia, and China.
  • Initiation of filter validation studies by providing inputs required for the selection of desired filters to the vendor, and reviewing the filter validation protocols and reports.
  • Initiation of extractable and leachables studies by providing inputs required for the selection of components required for the product.
  • Performing an investigation on any OOS/OOT observed during exhibit batches or stability.
  • Handling deficiencies and preparing consequent responses according to regulatory market procedures and requirements.
  • Well-versed in using SAP transactions like C223, CS03, C201, CS01, ZPP21, BMBC, MM03, MD04, MD11, CS15, etc.
  • Maintenance of lab equipment, areas, and SOPs.
  • Well-versed in using LIMS, D2 Documentum, and TrackWise applications for handling elements of the quality management system (Change Control, Incidents, Incident Investigations, Deviations, Corrective and Preventive Actions, Action Items, Standard Operating Procedures (SOPs), etc.).
  • Conducted team member meetings and updated members on best practices and continuing expectations.
  • Enhanced team productivity by implementing efficient workflow processes and optimizing resource allocation.
  • Set clear team goals and delegated tasks and set deadlines.
  • Oversaw the successful execution of multiple projects by effectively managing risks and addressing potential issues proactively.

Research Associate - II

Alphamed Formulations Pvt Ltd
06.2015 - 09.2016
  • Company Overview: Aspen Pharma.
  • Performing pre-formulation studies for the development of new products.
  • Timely development of drug products that are non-infringing, robust, stable, and bioequivalent to the reference product for the US, European, and Canadian markets.
  • Execution of process optimization batches for developing batches.
  • Development of ANDA products for regulatory markets.
  • Developing various generic formulations of solid dosage forms in lab scale, scale-up, and exhibit batches.
  • Preparation of a pre-product development strategy.
  • Execution of experimental work and documentation.
  • Maintenance of lab equipment, areas, and SOPs.
  • Stability management: bench and lab scale, along with the preparation of summary reports.
  • Preparation of stage-wise Product Development Reports. Providing the necessary data/documents for the license application for manufacturing and regulatory filings.
  • Implemented QbD concepts and DOE concepts for product development.
  • Interpretation of analytical/bio-study data and familiarity with statistical analysis.
  • Execution of experimental work and documentation.

Research Fellow

Pellets Pharma Limited
06.2013 - 05.2015
  • Performing pre-formulation studies for the development of new products.
  • Timely development of drug products that are non-infringing, robust, stable, and bioequivalent to the reference product for regulatory and ROW markets.
  • Execution of process optimization batches for developing batches.
  • Development of ANDA products for regulatory markets.
  • Developing various generic formulations of solid dosage forms in lab scale, scale-up, and exhibit batches.
  • Preparation of a pre-product development strategy.
  • Execution of experimental work and documentation.
  • Maintenance of lab equipment, areas, and SOPs.
  • Stability management - bench and lab scale, along with the preparation of summary reports.
  • Preparation of stage-wise Product Development Reports. Providing the necessary data/documents for the license application for manufacturing and regulatory filings.
  • Interpretation of analytical/bio-study data and familiarity with statistical analysis.
  • Execution of experimental work and documentation.

Education

Master's in Pharmacy - Pharmaceutics

HKE'S College of Pharmacy
Gulbarga, Karnataka
03-2013

Bachelor's degree in Pharmacy -

HKE'S College of Pharmacy
Gulbarga, Karnataka
09-2010

Board of Intermediate -

SVS Junior College
Warangal, Telangana
03-2006

Board of Secondary Education -

Millennium High School
Warangal, Telangana
03-2004

Skills

Formulation R&D: Formulation development of various solid orals [Tablets, Capsules & Pellets] and Injectable dosage forms [Suspensions, Lyophilization, Prefilled Syringes, Liquid etc,]

Awards

- Received "Best Employee For The Year - 2022" at Mylan Laboratories Limited, Bangalore., 

- Attended Parenteral Drug Association on “PDA 737 Terminal Heat Sterilization”., 

- Presented a poster on “Oral Dispersible Tablets” in 2nd Indian Pharmaceutical Association Students Congress held in Acharya and B.M. Reddy college of Pharmacy, Bangalore, Karnataka in June2009., 

- Participated 6th National Seminar in SHRI VISHNU COLLEGE OF PHARMACY, Bhimavaram, A.P in 2012, 

- Attended one day seminar on use of excipient in different dosage forms by Evonik, Datwyler & west pharma related to selection of Rubber Stopper & Extractable studies, Sartorius & Merck Millipore related to Selection of filters and filter validations studies etc.

Timeline

Senior Team Leader

Mylan Laboratories Limited
03.2023 - Current

Research Associate - II

Alphamed Formulations Pvt Ltd
06.2015 - 09.2016

Research Fellow

Pellets Pharma Limited
06.2013 - 05.2015

Master's in Pharmacy - Pharmaceutics

HKE'S College of Pharmacy

Bachelor's degree in Pharmacy -

HKE'S College of Pharmacy

Board of Intermediate -

SVS Junior College

Board of Secondary Education -

Millennium High School

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