Senior Executive - MSAT Process and Commercial @ ExecBoardinAsia

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for activities on own projects.
• Lead process, product and device improvements, create data packages by justifying recommendations for improvements in production processes and collaborate with technical staff to implement process technology initiatives.
• Author protocols for process and cleaning validation, execute the validation studies in partnership with Operations Departments and write validation reports.
• Provide technical leadership in investigations to determine root cause and implement appropriate corrective and preventive actions.
• Develop process flow diagrams for illustrating critical process and material flow.
• Assist Technology Transfer, including Gap Analysis and Process Transfer Risk Assessments.
• Execute laboratory runs and writes technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancies and investigations.
• Partner with manufacturing to meet the production schedule, ensure commercial supply, uphold quality standards and driving towards zero defects.
• Evaluate new materials and primary packaging components.
• Analyze, apply, and interpret information and identify cause and effect relationships.
• Contribute to continuous improvement of current operations to improve Overall Equipment Effectiveness (OEE), quality and/or productivity using current methodologies.

Job Responsibilities:

• Need to demonstrate the company core values and cultural abilities to be a critical team member of GTE Process and Commercial Support team.
• To be a Team member supporting the GTE transfers and close working with the GTE Process Owners /
• Leads to take complete and accountability in ensuring the planned molecule is transferred as per RFT (Right First Time) principles.
• Taking lead responsibility from MSAT in the area of PV support / commercial support at the manufacturing areas working closely with manufacturing colleagues.
• Execute the Lab Scale, Developmental batches, feasibility batches, Stability batches, Stability Studies as per plan
• Prepare Technical data, Gap assessment, Risk assessment reports, Identifying and evaluating CPPs related to process engineering aspects, Stability data, Annual Product Quality Reports, Technical documents from originating site
• Flexibility towards work hours as per the requirement of the projects.
• Coordinate with external customers like Filter validation service providers, Vendors etc.
• Evaluate manufacturing Process and Parameters/ CPPs for Scale up, Pre Exhibit and Exhibit batches manufacturing.
• Support the investigations through Process Manufacturing techniques.
• Complete the M-1 Certification through the company Six Sigma and display the use of the Statistical tools in the process commercial related activities.
• Plan and execute for Technology Transfer process including various activities like procurement of API, excipients, equipment s for the developmental, Optimization, Scale up Pre Exhibit and Exhibit batches
• Prepare necessary guidelines/ SOPs for Developmental/ Technology Transfer activities
• Technical support to Manufacturing Team for smooth launching of products.
• Trouble shooting, ongoing technical support to Manufacturing team for Process validation, continuous process verification and Process improvements, LCM and CI activities.
• Prepare Scale up Protocols and Reports, Technology Transfer Protocols and Reports, Batch Manufacturing Records, Product Development Reports, Bill of Materials etc.
• Ensure the compliance to cGMP/ cGLP, organizations procedures and practices.
• Ensure all the safety precautions are followed while at work.