Documentum - D2
Shashank Nagubothu
Formulation Research and Development
Bengaluru
Work Preference
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
13
13
years of professional experience
1
1
Certificate
Work History
Senior Team Leader
Mylan Laboratories Limited
09.2016 - 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, Karnataka03-2013
Bachelor's degree in Pharmacy -
HKE'S College of Pharmacy
Gulbarga, Karnataka09-2010
Board of Intermediate -
SVS Junior College
Warangal, Telangana03-2006
Board of Secondary Education -
Millennium High School
Warangal, Telangana03-2004
Skills
Formulation R&D: Formulation development of various solid orals [Tablets, Capsules & Pellets] and Injectable dosage forms [Suspensions, Lyophilization, Prefilled Syringes, Liquid etc,]
Technology transfer: Technology transfer of solid orals/ Injectable dosage forms
Software Skills: GEP, Smart Source, SAP, TrackWise, D2 Documentum and LIMS
Communication: Telugu, English, Hindi and Kannada
Certification
Attended Parenteral Drug Association on “PDA 737 Terminal Heat Sterilization"
Affiliations
- Received "Best Employee For The Year - 2022" at Mylan Laboratories Limited, Bangalore.,
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Software
SAP
TrackWisw
LIMS
SmartSource
GEP
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Telugu
Bilingual or Proficient (C2)
KANADA
Upper intermediate (B2)
Timeline
Attended Parenteral Drug Association on “PDA 737 Terminal Heat Sterilization"
01-2025
Senior Team Leader
Mylan Laboratories Limited
09.2016 - 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
Awards
- 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.