Karthik Periyasamy

A Highly focused, self-initiated, results-driven professional with comprehensive accomplishments leading a process development team with overall 10 years of experience in Biotech/Pharmaceutical industry, upstream Bioprocess Development, Biotransformation, Biocatalysis and Molecular biology and basic DSP process.Upstream media optimization (DOE), strain improvement, scale-up/scale-down of processes and technology transfer to manufacturing scale (cGMP), process characterization, Raw material evaluation and qualification, MFR, Developmental Report preparation, Technical report preparation, RND SPOC person for handling of OOS/OOT/Deviation and regular follow up of commercial batches (100kL scale).Expert in handling of Bacteria, Fungal, Yeast, Pichia and Streptomyces system. Good experience in Biocatalysis & Biotransformation for API. Data analysis and interpretation using Python, Power BI and handled SAP, Track wise, DMS, and E-BMR investigation software, Project managements.

Associate Scientific Manager-I (Sep 2020 to till date )-Biocon Ltd, Bengaluru, India

• POC establishment and Process development of new portfolio fermentation products.
• Designing of DOE approaches on media and process development for Antifungal, Statins, Immunosuppressants production and working on strain improvements
• Involving in implementation of Quality by Design (QbD) system in New R&D lab set-up with IO, OQ and PQ.
• Work in collaboration with various stakeholder like pilot plant operations, Analytical, downstream to devise scale-up strategies for fermentation processes and regular project progress updates with programme Management team. 
• RND SPOC person for Supporting of Manufacturing activities (100kL cGMP facility) with PETT (Process Engineering and Technology Transfer) and investigation of OOT/OOS/Deviations and troubleshooting and closure of deviations and CAPA for all the commercial batches with CFTs (Site QA, Regulatory affairs and Manufacturing QMS team).
• Preparation of Laboratory annexures, Process protocol, MFR, Development Report, review of BMR and risk assessment reports and FMEA for new fermentation API and pipeline API.
• Alternate vendor development and qualification for critical Raw materials

• Worked on strain improvements, media and process development for the production of Threonine aldolases, alcohol dehydrogenases and deacylases for Drxidopa, Neproxine and sitagliptin biotransformation
• Initiates, directs and executes scientific research for innovation and process improvements
• Knowledge of GMPs as applied to process development and scale up
• Prepare/review technical documents including development /tech transfer reports, batch records, SOPs. 
• Supervise batching of media for fermentation runs, reviews worksheets and batch records. Monitor/Supervise in process fermentation and Lab-scale validation.
• High Cell Density fermentation for Reductases and aldolases from recombinant E.coli and Biotransformation and Biocatalysis for API.
•  Protein Purification with IMAC resins (CR11), HP20, Phenyl sepharose, Unosphere Q and downstream processing includes Clarification, Homogenization, Microfiltration, Ultrafiltration, Diafiltration, and Tangential flow filtration (TFF), Lyophilization and Spray drying at industrial scale.
• Laboratory maintenance, including equipment maintenance and ordering of supplies as needed.
• Maintains documentation of experiments and/or batch records according to good documentation practices and accurately reviews batch records and other data, ensuring consistency from 5 Ltr to 10KL fermentor.

Senior Research Fellow (3.5 years) in Anna University, Chennai, India.

Erasmus Mundus Fellow (2.5 years) in Université Grenoble Alpes, France.

R&D Executive-Jul 2010 to Jul 2012-TexBiosciences (P) ltd, Chennai, India

• Fungal strain improvement through UV, NTG & EMS mutation and High throughput screening of higher titre mutants.
• Media optimization and Process development by Design of Experiments (DOE) for the increased production of Acid Xylanase, acid Cellulase and beta 1, 3-glucanase production through submerged fermentation and solid-state fermentation from Tricoderma viridae. Alkaline protease from Bacillus licheniformis. Pectinase enzyme production in Aspergillus niger.
• Cloning of Amylase gene from Bacillus licheniformis and Expressed in E.coli by infusion strategies and screening the clones, Cultivation of clones in appropriate seed & production media, Enzyme activity analysis.

• Involved lab scale Process development for the increased productions of Arachidonic acid (ARA) and Docosahexanoic acid (DHA) vide submerged fermentation at shake flask level and solid-state fermentation at lab koji.
• Lab scale Process development & media optimizations for the increased production of Amyloglucosidase Enzyme in Rhizopus sp vide submerged and solid-state fermentation.
• Screening of Raw Starch Hydrolyzing Glucoamylase GRAS fungus (Rhizopus sp and Aspergillius niger from starch processing industrial wastes. 

2012-2018 Ph.D. (dual) in Biotechnology (fermentation) from the Université Grenoble Alpes, France and Anna University, Chennai, India.2005-07MSc., Bioinformatics, Periyar University, TN, India 2002-05BSc., Microbiology, Bharathidasan University, TN, India.