The Tech Transfer Lead serves as a subject matter expert in manufacturing operations, working closely with quality, regulatory, manufacturing, engineering, and R&D teams. This role coordinates the transfer and implementation of projects and technologies from development groups and customers to the manufacturing site. The Tech Transfer Lead designs and optimizes manufacturing processes for new or modified products to ensure robust, reliable, and compliant production at commercial scale. The position covers the full product lifecycle, including development, stability studies, validation batches, and cleaning validation and verification activities.

• Lead the execution of new product technology transfer and cleaning projects, ensuring timely, compliant, and successful delivery.
• Prepare the manufacturing site for new product introduction, including readiness of equipment, processes, and documentation.
• Communicate plant-related issues and tasks to project teams, particularly regarding scale-up, new equipment, validation activities, and batch manufacturing.
• Conduct risk assessments, such as FMEA, to design robust and reliable manufacturing processes.
• Act as the primary plant liaison for manufacturing processes across internal departments and external units.
• Draft master batch records and protocols for development, stability, and validation batches.
• Translate development findings into scalable, reproducible manufacturing processes suitable for commercial production.
• Provide technical documentation and input for regulatory submissions and responses.
• Serve as the primary contact for manufacturing-related inquiries and resolution of technical issues.
• Support scale-up evaluations and technical assessments related to manufacturing changes and process improvements.
• Assist with investigations, corrective action plans, and material change requests to maintain product and process integrity.
• Develop and execute validation protocols and investigative studies for processes, equipment, and cleaning activities.
• Review technology transfer documentation in collaboration with regulatory and other stakeholders to ensure accuracy and compliance.
• Coordinate with external customers and vendors to support technology transfer and manufacturing initiatives.
• Track and report on departmental assignments, including project time tracking, APQRs, and product-related activities.
• Support the onboarding of new department employees and provide first-level technical guidance to team members.
• Identify process gaps and develop action plans to address and resolve them, driving continuous process improvement.

• Bachelor’s degree in science, engineering, or equivalent experience.
• 3–5 years of experience in product development, process scale-up, or technology transfer.
• Minimum 2–3 years of experience working within a cGMP manufacturing setting, preferably in the pharmaceutical industry.
• Experience working in aseptic, cleanroom environments.
• Experience with technology transfer for processes and equipment, including quality, process optimization, and process improvement.
• Experience writing and owning change controls within a regulated environment.
• Strong interpersonal skills with the ability to work effectively across all organizational levels and cross-functional teams.
• Excellent oral and written communication skills, including technical writing and presentations.
• Expertise in cGMP manufacturing principles and practices.
• Knowledge of equipment and process engineering related to manufacturing operations.
• Understanding of quality systems and requirements in a regulated manufacturing environment.
• Experience with product formulation and sterile manufacturing processes.
• Familiarity with packaging, warehousing, and distribution operations.
• Knowledge of purchasing, contracting, and enterprise systems used in manufacturing organizations.

• Experience with pharmaceutical industry systems and tools, including TrackWise or similar change control and quality management platforms.
• Demonstrated ability to lead cross-functional projects and manage multiple priorities in a fast-paced environment.
• Proven capability in conducting risk assessments such as FMEA to strengthen process robustness.
• Experience preparing documentation for regulatory submissions and responding to regulatory inquiries.
• Background in cleaning validation and verification studies for manufacturing equipment and facilities.
• Experience dr