Hi, I’m
Chandra Sekhar Chella
Microbiologist
PRAKASAM,AP
Summary
Accomplished Microbiology Manager with 18 years of expertise in quality control, regulatory compliance, and microbiological testing for injectables, biosimilars, and vaccines. Proven success in establishing and managing microbiology laboratories and overseeing greenfield and brownfield projects while ensuring adherence to regulatory standards set by USFDA, UKMHRA, WHO, ANVISA, and SAHPRA. Strong analytical skills combined with a proven track record in leading investigations, including CAPA, deviations, and change controls using TrackWise. Ready to leverage extensive expertise in a dynamic international environment that fosters innovation and excellence.
Overview
18
years of professional experience
Work History
Biological E Limited (Vaccines Division)
Manager – Microbiology
03.2017 - Current
Job overview
- Leading Environmental Monitoring Program (Viable & Non-Viable).
- Overseeing microbiological aspects of Greenfield and Brownfield projects.
- Managing water system & HVAC qualifications.
- Ensuring compliance with regulatory audits, including USFDA and WHO.
- Conducting risk assessments and contamination control strategies.
- Investigating Out-of-Limit (OOL) results using Six-M, 5-Why and Root Cause Analysis.
- Handling QMS documentation (SOPs, change controls, CAPAs) using TrackWise.
Hospira Healthcare (A Pfizer Company)
Senior Executive – Microbiology
09.2014 - 03.2017
Job overview
- Led microbiological testing, environmental monitoring, and sterility assurance.
- Implemented improved contamination control strategies.
- Participated in regulatory audits (MHRA, USFDA, ISO, cGMP).
Dr. Reddy’s Laboratories (Biologics Division)
Assistant Manager (R1A) – Microbiology
04.2012 - 09.2014
Job overview
- Supervised microbiology lab operations for biologics manufacturing.
- Conducted method validation, verification, and endotoxin testing.
- Ensured compliance with regulatory and quality standards.
Hospira Healthcare (Previously Orchid Healthcare)
Executive – Microbiology
08.2008 - 04.2012
Job overview
- Led routine microbiological testing and sterility assurance programs.
- Managed water and HVAC system qualifications.
Prayag Nutri Products Pvt. Ltd.
Analyst – Microbiology
06.2007 - 08.2008
Job overview
- Conducted microbial limit tests and sterility assessments for food products.
Education
MVR PG College
M.Sc. from Microbiology
University Overview
GPA: 73%
S.V.K.P Degree College
B.Sc. from Microbiology
University Overview
- Additional Training: cGMP, ISO, Regulatory Compliance Training.
- GPA: 70%
Skills
- Handling QMS, Deviation & CAPA implementation
- Method Development, Validation & Verification
- Aseptic Media Fill & Cleanroom Monitoring
- Microbial Identification & Bioburden Testing
- Disinfectant & Antimicrobial Efficacy Testing
- Cleaning Validation & Hold Time Studies
- Container Closure Integrity Testing (CCIT)
- Equipment & Laboratory Qualification (Steam Sterilizers, LAF, Isolators)
PERSONAL DETAILS
Languages: English, Hindi, Telugu
DECLARATION
I certify that the information provided is true to the best of my knowledge and that I am responsible for its authenticity. Yours Sincerely, (Chandra Sekhar Chella)
CORE COMPETENCIES
- Microbiology Lab / Production Block (Green field / Brown field) Microbiology Management & Setup.
- Regulatory Compliance (USFDA, UKMHRA, WHO, ANVISA, SAHPRA)
- Environmental Monitoring & Contamination Control.
- Sterility Testing & Endotoxin Testing.
- Change Controls, Deviations & CAPA Management
- Risk Assessment & Quality Management Systems (QMS)
- HVAC & Water System Qualification.
- Good Manufacturing Practices (cGMP, ISO Standards)
- Strong Analytical & Problem-Solving Skills
- Team Leadership & Cross-Functional Collaboration
Timeline
Manager – Microbiology
Biological E Limited (Vaccines Division)
03.2017 - Current
Senior Executive – Microbiology
Hospira Healthcare (A Pfizer Company)
09.2014 - 03.2017
Assistant Manager (R1A) – Microbiology
Dr. Reddy’s Laboratories (Biologics Division)
04.2012 - 09.2014
Executive – Microbiology
Hospira Healthcare (Previously Orchid Healthcare)
08.2008 - 04.2012
Analyst – Microbiology
Prayag Nutri Products Pvt. Ltd.
06.2007 - 08.2008
S.V.K.P Degree College
B.Sc. from Microbiology
MVR PG College
M.Sc. from Microbiology