Mathew Thomas Mathukutty

Experience

• 

  Therapeutic Drug Monitoring Lab

  Feb 1999 - Apr 1999

  Microbiologist
• 

  Ana Laboratories

  Jul 1999 - Oct 1999

  Microbiologist
• 

  GSK Pharmaceuticals

  Nov 1999 - Mar 2012

  Microbiologist

  • Headed the fermentation stage for the batch process fermentation types• Implemented sterilization of fermenters in the plant for capacities around 1500 liters & 3000 liters• Key involvement to safeguard and maintain cultures, aseptic management, bulk inoculums supply to the fermentation plant, and sterility checking using plant sample analysis • Drafted documents/standard operating procedures (SOP)/Batch-sheets; cross- verified, and updated the drafts with the quality assurance team • Extensively involved in the preparation of pediatric drops like Betnesol Oral Drops, Calpol Pediatric Drops, nasal sprays, and ear drops in the Liquid Manufacturing Unit• Hands-on experience in working as a GMP personnel to support the establishment and maintenance of high-quality standards• Efficiently managed the packaging materials order process of the pediatric drops products • Determined the concentration of Folic acid and Vitamins like B12 in the B-complex syrups, studied microbial limits• Gained strong knowledge about the microbial limits, and calculated the drugs potency levels for Neomycin/Gentamycin/Tetracycline using microbial assay method • Conducted Bioavailability & Bioequivalence studies performance tests on human volunteers using drugs like Azithromycin/Clarithromycin• Provided technical assistance to external & internal customers for microbiological enquiries• Proactively participated in the development and improvement of processes for the existing & new products• Supported the management by providing recommendations and feedback as per the test results• Maintained up-to-date knowledge about the current & relevant worldwide regulatory requirements for the products manufactured• Ensured the microbiology laboratory is fully equipped with the required resource to execute the tests efficiently • Oversaw and maintained a safe and secured laboratory environment • Tested water for microorganisms and other chemicals during water processing cycles Show less

• 

  Agilus Diagnostics

  Jan 2013 - now

  Associate Research Officer

  • Leading a team of 300 members as a coordinator at Fortis Hospital and SRL Labs • Analyzing & validating the data acquired from Network Labs, and issuing validation certificates promptly• Profound experience in working with validation instruments related to Haematology, Microbiology, and Immunoassay sections• Demonstrated experience in detailed documentation of the results obtained • Extensively involved in the validation process of ELISA based kits• Strong knowledge in On-site validation and Central Validation of kits and instruments • Hands-on experience in handling systems like Advia Centaur, Cobas e411, Immulite 1000, Dimension RxL Max, Beckman DxI 800, Beckman LH 750, Cobas 6000, Cobas 8000, and BN II Nephelometer• Managing the operation of Laboratory Information Management System (LIMS)• Interpreting the results of COVID 19 specimens by processing RT PCR tests • Performing in-depth interviews and facilitation for the research subjects• Developing and maintaining up-to-date knowledge and awareness about the research findings/issues/trends• Building a warm relationship with clients for promoting industry development and market intelligence• Skillful in developing liaison with colleagues and maintaining amicable relationships• Designing and conducting laboratory/field experiments to improve production efficiency Identifying requirements and implementing new research integrity and compliance policies and procedures as per the need• Maintaining accurate and comprehensive records of research integrity and compliance activities• Adept at drafting reports, illustrating graphical data, and translating complex findings into accurate & detailed documents• Dexterous in delivering the research findings in customized report formats as per requirement Show less