CHETAN MANIKANTH KUMAR
Hyderabad
Summary
Accomplished professional with expertise in sterile production and aseptic processing, honed at Dr. Reddy's Laboratories. Proven track record in supporting USFDA and WHO audit readiness. Adept in cross-functional collaboration and documentation management. Recognized for exceptional GMP discipline and effective communication, ensuring seamless operations and compliance.
Overview
11
11
years of professional experience
Work History
Team Member
Dr. Reddy's Laboratories
Hyderabad
02.2025 - Current
- Supporting sterile injectable cartridge line project.
- Conducting FAT/SAT for autoclaves, compounding vessels, bung processors.
- Executed FAT at BAUSCH + STROBEL, Germany.
- Supported USFDA audit readiness.
- Preparing URS, DQ, SLIA, commissioning, QRA.
- Managing shifts, validated equipment state.
- Reviewing BMR & online cGMP documentation.
- Cross-functional coordination.
Executive
Indian Immunologicals Limited
Hyderabad
06.2018 - 01.2025
- Managed blending & sterile filtration for vaccines.
- Operated CIP/SIP systems.
- Supported Hepatitis-A tech transfer.
- Collaborated with Manufacturing, TT, R&D.
- Worked with QA/QC on validation activities.
Senior Production Assistant
Shantha Biotechnics Pvt. Ltd.
Hyderabad
09.2014 - 06.2018
- Performed aseptic operations (UDAF, LAFU).
- Buffer prep, formulation & sterile filtration.
- BMR documentation, filter integrity testing.
- Supported WHO audit readiness.
- Supported validation & commercial batches with zero deviations.
- Maintained audit compliance with accurate documentation.
- Recognized for GMP and aseptic discipline.
- (Sanofi)
Education
Bachelor of Science - Biotechnology
GITAM University
Vishakhapatnam01.2013
Skills
- Sterile production and aseptic processing
- Vaccine formulation
- CIP and SIP
- Equipment qualification
- Buffer and media preparation
- Sterile filtration
- Documentation management
- SAP and PAS-X proficiency
- EVAL and DocuSign expertise
- MS Office applications
Languages
- Telugu
- English
- Hindi
Personal Information
- Date of Birth: 10/23/91
- Marital Status: Married
Timeline
Team Member
Dr. Reddy's Laboratories
02.2025 - Current
Executive
Indian Immunologicals Limited
06.2018 - 01.2025
Senior Production Assistant
Shantha Biotechnics Pvt. Ltd.
09.2014 - 06.2018
Bachelor of Science - Biotechnology
GITAM University