Design Expert
Repaka Sarath Chandra
Formulation Scientist
Hyderabad
Summary
Highly skilled Formulation Scientist with a decade of hands-on experience in designing, optimizing, and scaling up oral solid dosage forms. Proficient in conducting research, analyzing data, and developing innovative formulations. Proven track record of successful product launches and reformulations. Adept at collaborating with cross-functional teams to ensure seamless commercialization. Passionate about staying abreast of industry trends and advancing pharmaceutical science.
Overview
10
10
years of professional experience
7
7
Certifications
3
3
Languages
Work History
Formulation Scientist
PDU Orals - Novartis Healthcare Pvt Ltd.
08.2018 - Current
- Conducted Pre formulation and formulation studies to optimize drug delivery systems for tablets, capsules other solid oral dosage forms
- Developed clinical serviceable forms (both Solids orals and Liquid orals) for early phase oral portfolio
- Supported multiple FMI late phase projects of Novartis with respect to process optimization, Life cycle management and scale up activities from lab to plant
- Played an active role in the expansion of R&D lab with respect to selection of new R&D scale equipment’s as per the project landscape requirements
- Developed various working procedures for various new equipment’s in the lab to enable a new user working on the equipment
- Worked as DA administrator and ensured that the source documents generated in the team are as per the global standards
- Successfully implemented an IQP project to optimize the call off and forecast of excipients, leading to significant reduction timelines and material wastage at lab scale using SAP
- Developed a SharePoint in collaboration with IT team and creating a paperless process for DS and DP reconciliation
- Involved in design, experimentation, and validation of ROCOPACK (simulation tool) as a part of material sparing technique for roller compaction in Novartis
- Developing TiO2 free coating systems in collaboration with external vendors for multiple projects of Novartis.
Formulation Scientist
Dr. Reddy’s Laboratories
07.2014 - 07.2018
- Preformulation studies
- Formulation of laboratory scale batches for solid oral dosage forms, interpretation of formulation analytical result and scale up
- Formulation of fixed dose combinations, amorphous solid dispersions using continuous manufacturing technologies
- Inventory management and all other activities related to formulation development
- Application of QBD principles including QTPP, CPP, CQAs and risk assessments
- Developed and filed NCE-1 molecules in an efficient way by following a design-based approach of risk assessment to understand the QTPP’s, CQA’s of the project and de risking the CQA’s as the project is developed
- Addressed multiple post filing queries on time by seamlessly working with the CFT, analyzing historical data, authoring justifications, and ensuring the post filling queries are addressed as per the expectations within the timeline
- Application of Design of Experiment (DOE) to optimize formulation and manufacturing process parameters to build a robust process for manufacturing and for easy scale up
- Proficient in using software tools such as Minitab (20), JMP (17), and Design Expert (13).
Education
PG. Diploma in Patent laws -
NALSAR
M. Pharm. (Pharmaceutics) - undefined
BITS Pilani, Hyderabad Campus
B. Pharmacy - undefined
MCOPS, Manipal University
Board of Intermediate, (BIPC) - Biology,Physics And Chemistry
Kakatiya Academy
HyderabadBoard of Secondary Education, Carmel High School -
Carmel High School
MandamarriSkills
Formulation Development and optimization
DOE and Statistical AnalysisScale Up and ManufacturingProject ManagementTeam PlayerProblem-SolvingSOP authoringPara 4 filingsCommercial scale up and technology transferReport Writing
Microsoft Excel
Batch Record Analysis and results interpretation
Certification
Foundations of Project Management (Coursera Jan 2023)
Confirmation
I hereby confirm that all the information shared is true as per my knowledge.
Equipment
- Tablet compression machines (FETTE, KORSCH, KAMBERT, Cadpress)
- Rapid mixer granulators (both top-driven and bottom-driven)
- Stylone compaction simulators
- Tablet coaters (GPC1.0 2.0)
- Twin screw extruders (omega 10P, 12P, and 20P)
- Fluid bed processors
- Roller compactors (Gerteis minipactor, Alexanderwerk BT120)
- Powder bottle filling machines
- Capsule filling machines (both dosator and dosing disc models)
- Well-versed in generating and interpreting data from commonly used in-process control tests and sophisticated instruments such as SEM, FT4, Accupyc, Geopyc, Camsizer, Kraemer, Revolution, Evolution powder flow tester, and other equipment used in the lab.
Software
Excel
PPT
SAP
JMP
Timeline
Formulation Scientist
PDU Orals - Novartis Healthcare Pvt Ltd.
08.2018 - Current
Formulation Scientist
Dr. Reddy’s Laboratories
07.2014 - 07.2018
PG. Diploma in Patent laws -
NALSAR
M. Pharm. (Pharmaceutics) - undefined
BITS Pilani, Hyderabad Campus
B. Pharmacy - undefined
MCOPS, Manipal University
Board of Intermediate, (BIPC) - Biology,Physics And Chemistry
Kakatiya Academy
Board of Secondary Education, Carmel High School -
Carmel High School