Technical Product Manager – CMO Technical in Contract Manufacturing Organization in GSK CH (Sterling Drug (M) Sdn. Bhd.), Kuala Lumpur, Malaysia.

Region Head TPO - Manufacturing Science & Technology, International Opreations (ISEA & APAC)

TPO Project Mangement, Third party manufacturer identification, perform cross functional risk assessment & qualification of CMOs, Project Management, Planning and execution of technology transfer projects, Technical Trouble shooting, Drive value creation projects, Manages new product launch, Executing operational excellence & Quality compliance in all technology transfers in CMOs.

Process Technology Transfer, Validations, Cleaning Validations, Equipment Qualification for Liquid Dosage forms for Regulated Markets.Project Management.

Formulation Research Development, Product Delivery as per schedule, Project Management, Planning and execution of Registration Batches, BE Compliance, supporting Dossier Filing & Queries Handling, Customs Formulation Development and Client Handling, Commercialization of approved products, Trouble shooting, Audit Compliance, Administration, Stores and inventory control, Procurement of R&D equipments /Change parts, Training People and Team Building.

Responsible for development of stable formulation and optimized scalable process for oral solid dosage forms intended for filing Abbreviated New Drug Applications (ANDA) in regulated markets. Developing Prototype Formulation,Optimizing the Process, Specification Setting for API and finished products.Executing Technology transfer and coordinating pivotal BE study for multiple projects.Co-coordinating with cross functional team for data generation and facilitating the successful ANDA… Show more Responsible for development of stable formulation and optimized scalable process for oral solid dosage forms intended for filing Abbreviated New Drug Applications (ANDA) in regulated markets. Developing Prototype Formulation,Optimizing the Process, Specification Setting for API and finished products.Executing Technology transfer and coordinating pivotal BE study for multiple projects.Co-coordinating with cross functional team for data generation and facilitating the successful ANDA filing process.Successfully lead the API Vendor Qualification for filed/approved products for US, Europe and Australia markets.Coordinating and executing the Scale up and Exhibit batches of alternate API vendor qualification products for Variation filings in US/Europe countries.Key accomplishmentsSuccessfully filed 3 ANDAs for EU Markets. Successfully filed 8 PAS filings for USA Markets. Two ANDAs filed for Australian market.Successfully conducted site transfer, tech transfer activity and assisted for variation filing for post approval changes of 5 products for France market 2 for Germany Market.Core participant in the qualification and filings of alternate API vendors for 20 molecules with US FDA and 14 molecules with EU countries.As a formulation lead, coordinated and solved many issues pertaining to firm up the Specifications for many API and Drug formulations for US/EU and Australia market.Trouble shooting: Successfully solved commercial issues of couple of high volume products for smooth production. Received Ranbaxy's Appreciate Award - 2007 for this trouble shooting efforts.Validation: Monitored the smooth execution of Validation Batches of approved products.A key member in cross functional team which won the company's "Global Appreciate Award-2007". Received company's "R&D Appreciate Award-2008" for a successful tech transfer and variation filing activity of site transfer projects. Show less

Developed, optimized, and transferred manufacturing processes to commercial scale of a Class-II molecule, and executed 3 batches during commercial manufacture.Team member in the development of optimized scalable processes for manufacturing of tablet in tablet formulations.Scaled up of an IR/ER formulation in the form of inlay tablets.Responsible for documentations, data analysis, compilation, and report making.Key accomplishmentsSuccessfully developed five stable… Show more Developed, optimized, and transferred manufacturing processes to commercial scale of a Class-II molecule, and executed 3 batches during commercial manufacture.Team member in the development of optimized scalable processes for manufacturing of tablet in tablet formulations.Scaled up of an IR/ER formulation in the form of inlay tablets.Responsible for documentations, data analysis, compilation, and report making.Key accomplishmentsSuccessfully developed five stable formulations and launched two molecules in domestic market (Indian market).Developed stable water miscible injection formulation of an insoluble drug; Having hand on experience in followings,IR/ER Tablet Processing: Wet granulation, dry granulation, fluid bed granulation Show less

Brand Assistance, Brand Management

Medical Representative