Small Scale Flex - Process Scientist

This is an exceptional opportunity to join a dynamic team providing process science support and leading new product technology transfers into the drug substance facility at Pfizer Grange Castle. At Grange Castle, our culture is our cornerstone, emphasizing engagement, leadership, and collaboration to deliver life-changing medicines to patients. Role Responsibilities As a Process Scientist/Engineer, you will: Serve as a key member of the tech transfer team, supporting new product transfers into the drug substance facility and representing the site at internal and external meetings. Document all aspects of existing processes and equipment to ensure seamless transfer to Grange Castle. Perform technology transfer tasks such as gap analysis, process transfer risk assessment, and process descriptions. Support the introduction of new materials and execute necessary process trials. Develop and execute process validation protocols in collaboration with Operations. Generate process validation reports and assist with regulatory filing submissions. Ensure alignment between process requirements and automation systems. Contribute to equipment specification, sizing, and verification, including key component and process instrumentation requirements. Collaborate with logistics, planning, QA, QC, Operations, and Regulatory Affairs to facilitate the transfer process. Lead significant process investigations and implement corrective actions (CAPAs) as necessary. Provide technical training to project teams on processes and technologies. Offer strategic input on facility and equipment design while supporting operational readiness. Deliver presentations to simplify complex ideas for technical teams, management, and business leaders. Maintain proficiency with quality systems, including change controls and commitments. Support regulatory inspections and inquiries. Oversee routine process monitoring and address significant adverse trends. Perform Continuous Process Monitoring (CPV) on commercial processes. Requirements Experience: 25 years in a manufacturing process, process development, or tech transfer environment. Technical Knowledge: Understanding of technical transfer, mammalian cell culture, protein purification, and validation processes. Compliance: Familiarity with FDA and EU licensing standards and quality systems. Preferred Skills: Experience with single-use systems and new material introductions. Proven technical learning aptitude and problem-solving capabilities. Demonstrated ability to plan and execute work assignments independently. Strong interpersonal and team collaboration skills across multidisciplinary and cross-site environments. Excellent verbal and written communication. Highly motivated and proactive approach. Skills Summary: Technical learning and troubleshooting expertise. Effective data interpretation and presentation skills. Capability to work both independently and in team settings. Commitment to quality and compliance. Skills: API FDA Process Development