Job
Description
Role & responsibilities Job Title: MSAT - Technology Transfer Specialist (Injectables) Job Summary: The MSAT Technology Transfer Specialist for Injectables will be responsible for overseeing the transfer of injectable drug products from development to commercial manufacturing. This role requires close collaboration with cross-functional teams, including R&D, Quality, Manufacturing, and Engineering, to ensure a seamless transfer process, operational excellence, and compliance with cGMP regulations. Key Responsibilities: Technology Transfer Oversight: Lead and coordinate the transfer of injectable drug products from development to commercial production facilities. Ensure that all documentation, including protocols, procedures, and specifications, is complete and accurate during the transfer process. Collaborate with R&D and other departments to troubleshoot and resolve technical issues during the technology transfer. Cross-Functional Collaboration: Work closely with internal teams (Manufacturing, Engineering, Quality, and Regulatory Affairs) to ensure alignment and understanding of technical requirements during the transfer. Serve as a point of contact between the development team and the commercial manufacturing site, facilitating communication and ensuring a smooth transition. Process Development and Optimization: Provide technical expertise to optimize manufacturing processes for injectables. Identify and implement process improvements to enhance product yield, quality, and cost-effectiveness. Ensure that manufacturing processes are scalable, robust, and compliant with regulatory standards. Regulatory Compliance: Ensure that all aspects of the technology transfer process adhere to cGMP (current Good Manufacturing Practices) and regulatory requirements. Support regulatory submissions by providing necessary documentation and technical information as needed. Training and Knowledge Transfer: Develop and conduct training sessions for production personnel, ensuring that they are well-prepared for the commercial production of the injectable products. Transfer critical knowledge related to formulation, filling, and packaging processes to manufacturing teams. Process Validation: Lead and support process validation activities, ensuring that processes are qualified and validated in accordance with regulatory requirements. Oversee the creation, review, and approval of process validation protocols and reports. Problem Solving and Troubleshooting: Troubleshoot and resolve any issues that arise during the technology transfer and manufacturing processes. Apply scientific and technical knowledge to identify root causes and implement corrective and preventive actions. Continuous Improvement: Lead or support continuous improvement initiatives to enhance the efficiency, quality, and consistency of the injectable manufacturing processes. Support initiatives to reduce cycle times, improve yield, and minimize waste. Documentation and Reporting: Prepare and review required technical documentation, including batch records, validation protocols, and reports. Ensure timely and accurate reporting of technology transfer progress, challenges, and resolutions to senior management. Project Management: Manage the technology transfer timeline, ensuring all milestones are met within established deadlines. Monitor the progress of technology transfer activities, identify potential risks, and implement mitigation strategies to ensure successful completion. Qualifications: Education : Bachelors or master’s degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field. Experience : 5+ years of experience in technology transfer, manufacturing, or process development within the pharmaceutical industry, with a focus on injectables. Strong knowledge of cGMP and regulatory requirements for injectable drug products. Proven experience in process optimization, troubleshooting, and scaling up manufacturing processes. Experience with project management and cross-functional team collaboration. Skills: Strong technical understanding of injectable drug products, including formulation, filling, and packaging processes. Excellent communication, teamwork, and leadership skills. Proficient in technical documentation and report writing. Familiarity with Lean, Six Sigma, or other process improvement methodologies is a plus. Preferred candidate profile
