Tech Transfer Specialist

Description : Our clients Technical Operations team supports global manufacturing activities across both internal and external sites. The team delivers expert technical leadership, process ownership, and rapid solutions to ensure the successful execution of the product pipeline and to maintain technical excellence post-commercialisation. This position requires strong cross-functional collaboration with both internal and external stakeholders, including Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Supply Relationship Management, External Manufacturing, Operations, Quality, and Regulatory functions. Key Responsibilities : Develop and implement Technology Transfer (TT) strategies including Process Validation and Control Strategy for both biologics (drug substance and drug product) and small molecule drug substance and oral solid dosage forms. Lead technical gap assessments and ensure execution of related mitigation plans. Author and review project documentation, including supporting protocols and reports. Ensure site-specific Cleaning Validation and Media Fill strategies align with global standards. Provide subject matter expertise on technical aspects of regulatory responses and support regulatory inspections as needed. Promote and support implementation of best practices in TT and Validation across the network, collaborating with other team members to drive continuous improvement. Required Experience : Minimum of 6 years experience supporting technology transfer for drug substance or drug product manufacturing. Demonstrated success managing tech transfer programs at both site and corporate levels in a GMP environment. Strong understanding of technical and cGMP requirements for tech transfer activities. Ability to present and defend TT-related topics during regulatory inspections. Experience in biopharmaceutical bulk drug substance (BDS) manufacturing and aseptic fill / finish operations. In-depth knowledge of relevant regulations and current industry best practices, including the interpretation and application of guidelines. Preferred Qualifications : Bachelors degree in Science, Engineering, or a related field. Highly organized, analytical thinker with strong attention to detail. Excellent written and verbal communication skills, including technical writing. Ability to effectively communicate technical and regulatory requirements and drive the implementation of TT projects Skills : Tech Transfer NPI GMP BDS OSD Technology Transfer Drug Product Manufacturing Benefits : On Site Parking