Technology Transfer Specialist

About the Job The Technology Transfer Specialist is responsible for supporting planning and execution of the transfer of sterile parenteral products and processes from development or external sites into commercial manufacturing. This role is responsible for supporting technology transfer of processes from any Fagron Sterile Services 503B Outsourcing Facility, including sites located in Canton, MA, Las Vegas, NV, and Wichita, KS. This role ensures process knowledge, control strategy, and regulatory commitments are translated into a robust, compliant, and scalable manufacturing operation. The position serves as the technical liaison between New Product Development (NPD) and Manufacturing. This role will be supported by the Technology Transfer Manager and work closely with New Product Development, Operations, Validation, and Quality at each site to support the Technology Transfer program. The Specialist will work with these departments on day-to-day priorities and support of additional projects. This candidate must be able to thrive in a fast-paced manufacturing environment, make decisions, and be capable of setting and balancing priorities. The Tech Transfer Specialist must be able to manage multiple tasks, projects with frequent changes and work with cross-functional partners at all levels in the organization. Pay: $100,000-$135,000 USD Annually Key Responsibilities Execute technology transfer plans by supporting end-to-end technology transfer for sterile injectable products (solutions, suspensions) from various sites. Ensure process parameters, critical quality attributes (CQAs), and critical process parameters (CPPs) are defined, controlled, and monitored. Support process risk assessments (FMEA) related to sterile manufacturing. Support process characterization, engineering runs, and performance qualification batches. Translate process development knowledge into manufacturing control strategies and batch records. Coordinate and support process scale-up from research and development into commercial manufacturing. Own or support change controls for new and existing processes. Support validation for aseptic processing, sterile filtration, filling, and container closure systems (including filter validation and container closure integrity testing). Ensure risk-based approaches aligned with site and regulated sterile compounding expectations. Author and/or execute process performance protocols, reports, and change assessments. Identify opportunities to improve process robustness, yield, and cycle time. Ensure data integrity and documentation practices consistent with ALCOA+ principles. Support monitoring performance metrics and driving continuous improvement initiatives. Basic Qualifications AS, BS, and/or minimum 2+ years equivalent experience in a pharmaceutical related discipline. A minimum 1 year of related working experience in sterile parenteral manufacturing is required. Experience working in cGMP environments that meet FDA, EMA, ICH guidelines, local regulations, and industry best practices is preferred. General knowledge of the pharmaceutical industry, brand and/or generics is preferred. This position may require up to 30% domestic travel including some overnights and weekends. What's on Offer? We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry. Ready for the challenge? Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer. #J-18808-Ljbffr Fagron Group