Summary: Accountable for providing scientific and process expertise to support Process Analytical Technology the implementation, understanding, monitoring and control of manufacturing processes. Must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required. Responsibilities: Provides scientific expertise in transferring, implementing, supporting, optimizing and troubleshooting real-time analytics (RTA) in support of conventional and continuous manufacturing. Addresses the implementation, maintenance, update, modification and lifecycle of in-line and at-line real time analytics models. Participates in multi-disciplinary teams for investigations, technology transfer, installation and qualification of PAT in support of conventional and continuous manufacturing processes. Executes scientific studies and study plans in support of RTA. Ensures availability and reliable operations of PAT equipment and sensors. Works with vendors and CROs to coordinate maintenance activities of PAT equipment including troubleshooting and repair. Plays a key role in data management, mining and process robustness monitoring related to PAT. Contributes to the manufacturing site for troubleshooting, product impact assessments during deviations and investigations. Applies process understanding to assist in process improvements and in process engineering activities to support existing and new products. Identifies and implements new PAT opportunities for HCO processes. Provides training to manufacturing operators, product scientists, and other functions as needed on PAT technologies. Supports RTA application projects. Knowledge/Skills: Masters o PhD degree in Chemistry, Pharmaceutical Technology or Engineering Three (3) years experience with Process Analytical Technology in a pharmaceutical manufacturing environment or manufacturing processes or equivalent research experience Proficient knowledge of FDA regulatory requirements Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant Able to write detailed technical reports Able to effectively present detailed technical information and respond to technical questions Knowledge of pharmaceutical business processes and equipment Ability to review SOPs and work instructions Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data Bilingual English/Spanish, both written and verbal are required Able to interact effectively with people to establish and maintain excellent working relationship with at all organizational levels Able to plan and prioritize multiple complex activities simultaneously Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary
