Mohan Kumar Krishnan Email & Phone Number

Singapore

* Chromatography Column techniques* Bioprocess Manufacturing* Aseptic Techniques* Filtration Techniques*

Singapore

* Handled a plant capacity of 50 -75 MT of API per Month. * Production and raw material planning as per requirement.* Process improvements, cost reduction and optimal utilization of process equipment’s.* Fulfill the requirements of internal and external customers.* Capex, Opex and manpower Planning.* Handled internal, external audits and compliance for the same.* Monitor, review and approve the cGMP related documents in timeline.* Prepared the off line reports and support the cross functional department to ensure the improvement of the system.* ERP (Microsoft Dynamics & Oracle e-business suite) Updating.* Ensure all the production activities meet the statutory and regulatory requirements.

* Involved in process suitability study in optimization phase of new product development in collaboration with R&D to stream line the scale up process later. * Preparation of Capex, Process Documentation File & BMR.* Process equipment selection with respect to process requirement, Safety & cost effectiveness* Facility creation according to the requirements.* Performed HAZOP review which includes failure mode effect analysis, critical parameters, process safety information and emergency preparedness.* Implementation of systems to comply with cGMP guidelines.* Trouble-shooting of the process during the trial phase of scale up.* Validation of process at plant scale.* Commercialization of process to a magnitude that meets future requirement.* Sent weekly report to all heads.* Successfully scaled up 3 products.* Good exposure on preparative HPLC (Column volume 125 L) operation.* Familiar with cGMP guidelines & Regulatory requirements.* Responsible for achieving performance measures for the month.* Worked in ERP environment and responsible for Product costing at the month end.* Work experience in CLEAN ROOM with class 100000 facilities

* In-Charge of shift activities* Sent Production performance & status report to the Production Head.* Responsible for achieving Performance measures for the month.* Process validation, BMR updation, Process Flow diagram, Risk Assessment register for new products.* Practiced ISO 9001,ISO14001, ISO18001 & cGMP norms in the plant* Work experience in CLEAN ROOM with class 100000 facilities which is operated by 0.3 micron HEPA FILTER AND LAMINAR FLOW FILTERS.* Producing the bulk drugs as per customer requirements particularly concentrating on the impurity present in the product and the residual solvents limits in PPM level based on the ICH guidelines.

Msc, Applied Chemistry

Bsc, Chemistry