Sunil Kumar. M
Hyderabad
Summary
Diligent professional with many years of experience and currently as a Manager at Adept Pharma and Bioscience Excellence Pvt. Ltd., with a proven track record in regulatory compliance and team leadership. Expert in microbiological techniques and project management, significantly enhancing laboratory efficiency. Demonstrated excellence in operations management and workforce management, ensuring adherence to GLP and regulatory standards.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Manager
Adept Pharma and Bioscience Excellence Pvt. Ltd.
11.2019 - Current
- Responsible for overall activities and scientific queries related to the microbiology department.
- To evaluate external audit observations, and develop responses and oversight for related action plans.
- International and domestic audit exposure: USFDA, MHRA, WHO, TGA, DCA, BIS, OECD-GLP.
- Authorize test reports as Authorized Signatory, granted by NABL.
- Microbiology lab design, qualifications.
- Review, planning, execution, and monitoring of work for the microbiology laboratory.
- Preparation, Review, and Execution of SOPs through QMS.
- Training of the personnel (workplace training) and GLP maintenance of the Microbiology Lab.
- To continuously investigate and trend invalid and out-of-specification results.
- To ensure appropriate and timely corrective actions are implemented.
- To evaluate external audit observations, and develop responses and oversight for related action plans.
- To ensure all established laboratory, regulatory, safety, and environmental procedures are followed.
- To adhere to the standards of quality as per GMP, company quality policies, and site SOPs standards.
- To ensure good documentation practices in all aspects and phases of the work, provide reports for review in a timely manner, work with other lab personnel on projects, and participate in (OOS) Out-of-Specification and failure investigations.
- Preparation, Review, and Execution of Protocols.
- Knowledge of software such as LIMS.
- Having practical exposure to various validations, such as BET, sterility, PET, MLT suitability, disinfectant, and water systems.
- Isolation and identification of microorganisms.
- Having practical exposure to various shelf life studies, such as microbiological media, cultures, dirty and cleaned equipment studies, etc.
- Area qualifications for viable monitoring through various methods (external services too).
- Responsible for maintaining change controls, incidents, and deviations.
- Responsible for the allotment of work to subordinates, and for reviewing the test data for any discrepancies and deviations.
- Responsible for investigating the root cause and deviations related to microbial data and procedures.
- To carry out DTL studies, such as the assay of heparin and LMWH (Enoxaparin, Nadroparin), as per USP, BP, and IP.
- To carry out an analysis of microbial analysis as per updated pharmacopoeias, such as BCC (Burkholderia cepacia complex) as per updated USP.
- Responsible for supporting cross-functional departments on any microbiology-related issues.
- Microbiological media suitability procedures.
- Maintenance of microbiological media stocks, microbial stocks, and consumables used for microbiological analysis, and chemical stocks.
- Analysis of antibiotic assays, such as Kanamycin sulfate, Neomycin, Erythromycin, Amphotericin B, and Amikacin sulfate.
- Facilitated team meetings and workshops to foster collaboration and share best practices.
Scientist
Edara Research Foundation
02.2017 - 10.2019
Sr.Microbiologist
Sipra Labs Limited
02.2012 - 02.2017
Quality Analyst
National Collateral Services Limited (NCML)
12.2010 - 01.2012
Education
M.Sc. - Microbiology
01.2010
B.Sc. - Microbiology, Genetics, Chemistry
01.2008
Skills
- Postgraduate Diploma in Computer Applications
- Compliance Management
- Project Planning
- Document Organization
- Process Optimization
- Strategic Team Guidance
- Team Resource Management
- Microbial Testing Procedures
- Proficient in Laboratory Safety Standards
- Risk Assessment
- Microbial Quality Assessment
- Effective Troubleshooting Skills
- Data-Driven Decision-Making
- Quality Management Proficiency
- Compliance with Laboratory Safety Standards
Certification
- DCA (Govt. of Telangana) approved “Microbiologist”.
- NABL approved “Microbiologist”.
- Successfully involved (from day one) in the GLP, DTL, NABL, DCA, CDSCO BIS and other certification procedures for the organization.
- Did add-on course in “Cheminformatics”.
- Won first prize during the occasion of annual day celebrations and presented a poster on “Histopathology And Its Role In The Pre-Clinical Studies” at Sipra labs limited.
- Won double Gold Medal during inter lab competitions held at SLL.
- Worked on “Production of Wine” using different fruits as project work while pursuing Bachelor’s Degree (Guide: Dr. Chand Pasha, Prof. at O.U.).
- Volunteered and participated ICBF (International Congress on Bioprocesses in Food Industries) & CRSI (Convention of the Biotech Research Society of India) held at Osmania University.
- Trained on ISO 17025:2005, 17025:2017, ISO 9001:2008 certifications.
- Participated in three day seminar on “Drug Designing & Futuristic Chemistry”.
- Presented a paper on “Status of Indian Agriculture since Independence”.
- Participated and won a prize in Poster Presentation on “Peizophiles”.
Previous working experience
- Edara Research Foundation, Scientist, QA- Microbiology/ In-vitro, 02/22/17 - 10/26/19
- Sipra Labs Limited, Sr. Microbiologist, Microbiology, 02/15/12 - 02/17/17
- National Collateral Services Limited (NCML), Quality Analyst, Testing and Certification (T&C), COMMGRADE, Delhi, 12/01/10 - 01/28/12
Research Publications
- Praveen kumar. Y, Sunil Kumar. M, Rajakumar. R, Kalyan Kumar. K., Assessment of Chemical properties of soils from different ecosystems located in Hyderabad, Journal of Pharmacognasy and Phytochemistry, 2019, 8, 1, 1909-1912
- Praveen Kumar.Y, Sunil Kumar. M, Rajakumar.R, Nanakram, Shanmukraju, Profiling of microbial community composition in different soil ecosystems by PLFA., International Journal of Research and Analytical Reviews, 2019
- In-vitro Antibacterial Efficacy of Acacia farnesiana seed extracts specifically directed against B.cepacia, B.multivorans and B.cenocepacia of Burkholderia Cepacia Complex (BCC)[under review]
Personal Information
- Date of Birth: 07/28/87
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
- English
- Hindi
- Telugu
- Marathi
Disclaimer
I hereby declare that all the information given above by me is true to the best of my knowledge and hereby bears all the responsibility of its truthfulness. I will be humbly grateful if given a chance to work in your esteemed organization.
Timeline
Manager
Adept Pharma and Bioscience Excellence Pvt. Ltd.
11.2019 - Current
Scientist
Edara Research Foundation
02.2017 - 10.2019
Sr.Microbiologist
Sipra Labs Limited
02.2012 - 02.2017
Quality Analyst
National Collateral Services Limited (NCML)
12.2010 - 01.2012
M.Sc. - Microbiology
B.Sc. - Microbiology, Genetics, Chemistry
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