Deputy Manager - Technology Transfer

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.