Job Description

Job Summary The incumbent will be responsible for supporting the successful transfer of pharmaceutical processes and technologies from the R&D phase to the manufacturing phase. This position will involve working closely with cross-functional teams, including R&D, Quality, Regulatory, and Manufacturing, to ensure smooth and timely implementation of processes at scale. The ideal candidate will have a strong technical background in pharmaceutical development, process optimization, and excellent problem-solving skills. Key Responsibilities Tech Transfer Coordination : Assist in managing the transfer of drug formulations, processes, and technologies from R&D to manufacturing. Ensure the seamless scaling of processes from laboratory to commercial production, maintaining quality and regulatory compliance. Support process development teams during the transfer phase and troubleshoot technical challenges as needed. Documentation and Compliance : Prepare and review the necessary documentation for tech transfer, including SOPs (Standard Operating Procedures), protocols, and reports. Ensure all documentation meets regulatory requirements and follows company standards. Support the creation of risk assessments and control strategies for the transferred processes. Cross-Functional Collaboration : Work closely with R&D, Manufacturing, and Quality Assurance teams to gather necessary data and insights for tech transfer. Coordinate between multiple departments to address any issues arising during the tech transfer process. Facilitate smooth communication across teams to ensure timelines are met and quality standards are upheld. Process Optimization & Problem-Solving : Identify potential improvements in transfer processes to enhance efficiency, reduce costs, and minimize risk. Investigate and resolve any challenges encountered during scale-up activities, ensuring the process works as intended at large-scale manufacturing. Conduct troubleshooting and provide technical support for any issues during tech transfer execution. Training and Support : Assist in training manufacturing personnel on new processes or technologies during tech transfer. Support the development of training materials and presentations to ensure smooth adoption of transferred processes. Project Management : Support the management of project timelines, deliverables, and milestones. Monitor progress and provide regular status updates to senior management and stakeholders. Track the progress of ongoing tech transfer projects and ensure adherence to established timelines and quality standards. Key Requirements: Educational Qualifications : Masters degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related field. Experience : 8-12 years of experience in pharmaceutical R&D, process development, or tech transfer, ideally in a GMP (Good Manufacturing Practices) environment. Prior experience with technology transfer in a regulated industry (preferably in pharmaceuticals or biopharmaceuticals). Technical Skills : Strong understanding of pharmaceutical development processes, including formulation, manufacturing, and scaling up. Experience with equipment, process technologies, and techniques used in the production of pharmaceutical products. Knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines. Soft Skills : Strong communication and interpersonal skills, with the ability to collaborate effectively across departments. Detail-oriented with excellent organizational and documentation skills. Ability to work in a fast-paced environment and manage multiple projects simultaneously. Other : Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word). Familiarity with process modeling and data analysis tools is a plus. Knowledge of project management tools and techniques is a plus.