SAI CHARAN REDDY BODA
Sr.Executive In Production Downstream
Hyderabad
Summary
Sr. Executive in Biopharma with 7 years of experience in downstream production, including hands-on experience in chromatography systems and Tangential Flow Filtration (TFF) systems. Holding an MSc in Biochemistry and having online an online certification course in Regulatory Affairs. Possesses knowledge of US FDA and EU regulatory guidelines, with an understanding of regulatory compliance, GMP principles, and pharmaceutical documentation. Seeking to leverage practical manufacturing experience, process knowledge, and regulatory training to transition into a Regulatory Affairs role and contribute to regulatory documentation, submission support, compliance activities, and product lifecycle management.
Overview
7
7
years of professional experience
Work History
Sr.Executive in Production Downstream
Curateq Biologics Private Limited
06.2025 - Current
Performing batch activities with the following GMP and GDP procedures.
Execution of area and equipment qualifications, production readiness, and compliance.
Performing column packing, unpacking, and evaluation.
Handling of the chromatography system, TFF system, and purification process in downstream.
Executive
Intas Pharmaceuticals Limited
03.2023 - 05.2025
Executed column packing and unpacking tasks in a laboratory setting.
Coordinating shift activities as per planned activities, including compiling GMP and GDP procedures, chromatography steps, TFF, drug substance purification, and filtration activities.
Executive
Biocon Biologics
11.2021 - 02.2023
Performing column packing and unpacking activities.
Coordinating shift activities as per planned activities, including compiling GMP and GDP procedures, chromatography steps, TFF, drug substance purification, and filtration activities.
Coordinated daily shift operations, optimizing workflow and resource allocation.
Jr.Officer
Hetero Biopharma
02.2020 - 10.2021
Executed column packing and unpacking activities, ensuring seamless operational workflow.
Conducted regular batch activities to support production processes. Coordinated daily operations to ensure compliance with GMP, and GDP standards.
Demonstrated respect, friendliness, and willingness to help wherever needed.
Assisted with day-to-day operations, working efficiently and productively with all team members.
Worked flexible hours across night, weekend, and holiday shifts.
Education
Master of Science - Biochemistry
Central University of Haryana
Mahendragarh, India 04.2001 -
Bachelor of Science - BIOTECHNOLOGY, BIOCHEMISTRY, CHEMISTRY
Aurora Degree And PG Collage
Hyderabad, India 04.2001 -
Skills
AKTA Process and AKTA Pilot Chromatography system operation
Novasep Chromatography system operation
AKTA chromatography operation
LIMS operation for Sample management
LIMS sample management
Biosc Operation
ERP Operation
Novasep chromatography operation
GMP and manufacturing documentation
Regulatory Affairs certification
US FDA and EU regulatory guidelines
Regulatory compliance awareness
Technical documentation and record review
Understanding of regulatory submissions and CTD/eCTD
Habbits
Reading Books
Watching movies
Timeline
Sr.Executive in Production Downstream
Curateq Biologics Private Limited
06.2025 - Current
Executive
Intas Pharmaceuticals Limited
03.2023 - 05.2025
Executive
Biocon Biologics
11.2021 - 02.2023
Jr.Officer
Hetero Biopharma
02.2020 - 10.2021
Master of Science - Biochemistry
Central University of Haryana
04.2001 -
Bachelor of Science - BIOTECHNOLOGY, BIOCHEMISTRY, CHEMISTRY
Aurora Degree And PG Collage
04.2001 -