Anitha Puppala
Hyderabad
Summary
Results-driven regulatory sciences manager with extensive experience at CuraTeQ Biologics, specializing in dossier preparation and query response. Proven track record in downstream process development and technology transfer, effectively leading teams to ensure timely submissions, and compliance. Stellar Award in recognition of outstanding contributions for 2015–2016 from downstream process development at Dr. Reddy’s Laboratories Ltd. Hyderabad. Certifications in Six Sigma Green Belt, drug development.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Manager, Regulatory Sciences (CMC-Drug Substance)
CuraTeQ Biologics Pvt.Ltd.
Hyderabad
01.2023 - Current
- Review the CMC content of drug substance dossiers (modules 2 and 3) for several biosimilar products, and make sure they are submitted on time to global health authorities (EMA, MHRA, & HC)
- Maintenance of list of source document list and submission information
- Review of scientific advice / briefing book packages
- Support for review and approval of change control or change management assessments
- Response strategy and respond to health authority questions on time
- Communication with development, quality and manufacturing/operations teams' subject matter experts to ensure CMC source documents needed for regulatory filings
- Good understanding of country specific requirements for biologics that enables the country specific regulatory filing strategies
- Identifies regulatory risks for products within the defined scope, communicates these risks, and ensures aligned plans for mitigation
- Process development, process risk assessment, process characterization, viral clearance, technology transfer, process consistency, manufacturing process, performance qualification, cleaning validation, and continuous process verification are few examples of the documentation reviews that ensure regulatory compliance
- Manage team members and other stakeholders for timely delivery of the assignments
Scientist, Downstream Process Development
Dr. Reddy’s Laboratories Ltd.
Hyderabad
01.2011 - 01.2023
- Company Overview: (Biologics Unit)
- Managing the team for day-to-day downstream operations to generate Drug Substance at R&D scale and proactively assumes responsibility
- Planning and evaluation of critical studies such as process development for each purification step, End to end process integration, scale down models, virus validation and process characterization activities
- Actively participated in investigation and root cause analysis of failures and supported to manufacturing for technology transfer and batch related queries
- During the product development phase, planning, coordination, and reporting for process intermediate hold time studies
- Review and closing purification process development documentation, including scale-up and technology transfer documents, process comparability reports, process development summary reports, process consistency reports, and process risk assessments
- Successfully scaled up the purification process to 200 L and 1000L scale for clinical campaigns
- Performed virus validation study for chromatography and nanofiltration stages at CRO site
- Assessment of novel technologies, including chromatography membranes, single pass TFF, and downstream process development for batches made using perfusion/ATF technology
- (Biologics Unit)
R&D Executive, Downstream Process Development
Sreeven Pharma Pvt. Ltd
01.2009 - 01.2011
- Isolation & purification of “PULMONARY SURFACTANT “from bovine lung
- “Lecithin” preparation from egg yolk, Preparation of “casein and caseinates”, Preparation of “Tryptone”
Education
M.Sc. - Biotechnology
Sri Venkateswara Institute of Medical Sciences University
Tirupati, AndhraPradesh01.2008
B.Sc. - Biotechnology
St. Pious X degree and PG College for women
Hyderabad01.2006
Skills
Dossier preparation
Query response
Downstream process development
Scale down model establishment
Process characterization
Viral validation studies
Technology transfer
Process validation
Certification
- Six Sigma Green Belt program, online, Indian Statistical Institute, Hyderabad, 2020
- ICH Q7 GMP for APIs, online, PDA
- Drug Development, online, Coursera
- Six Sigma principles, online, JMP
- Statistical Thinking for Industrial Problem Solving, online, LinkedIn
- IoT Foundations, online, LinkedIn
- System Thinking, online, LinkedIn
- Introduction to Digital Twins, online, LinkedIn
- Foundations of the Fourth Industrial Revolution, online, LinkedIn
Professional Honors And Awards
- Stellar Award, In recognition of outstanding contribution for 2015 – 2016 from downstream process development at Dr. Reddy’s Laboratories Ltd., Hyderabad
- BIG PAT ON THE BACK, Certification of appreciation for successful completion of hold time study at Dr. Reddy’s Laboratories Ltd., Hyderabad
- 1st prize, For poster presentation at Dr. Reddy’s Laboratories Ltd., Hyderabad
- Speed and Agility award, 2023, Annual celebration of Dr. Reddy’s Laboratories Ltd., Hyderabad
Timeline
Manager, Regulatory Sciences (CMC-Drug Substance)
CuraTeQ Biologics Pvt.Ltd.
01.2023 - Current
Scientist, Downstream Process Development
Dr. Reddy’s Laboratories Ltd.
01.2011 - 01.2023
R&D Executive, Downstream Process Development
Sreeven Pharma Pvt. Ltd
01.2009 - 01.2011
M.Sc. - Biotechnology
Sri Venkateswara Institute of Medical Sciences University
B.Sc. - Biotechnology
St. Pious X degree and PG College for women
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