Analytical Sciences Associate

📋 Description

• • Sumitomo Pharma Co., Ltd., a global pharmaceutical leader with a strong presence in Japan and the U.S. through Sumitomo Pharma America, Inc., is dedicated to addressing critical patient needs across a spectrum of therapeutic areas including oncology, urology, women's health, rare diseases, cell & gene therapies, and central nervous system (CNS) disorders. With a robust portfolio of marketed products and a promising pipeline of investigational assets spanning early to late stages, our mission is to accelerate the discovery, research, and development processes to bring novel and life-changing therapies to patients more rapidly. We invite dynamic, highly motivated, and innovative individuals to join our team.
• • We are currently seeking a talented and driven individual for the position of Associate, Analytical Sciences. This pivotal role is designed to provide essential support to our analytical operations and to champion data-informed decision-making throughout Technical and Quality Operations. The successful candidate will be instrumental in maintaining the integrity and accuracy of product static data within our Laboratory Information Management Systems (LIMS), working collaboratively with IT and Quality departments to continuously enhance system functionality and user experience.
• • A core responsibility of this position involves the advanced application of statistical techniques. This includes leveraging methodologies such as multivariate analysis and statistical process control (SPC) to drive continuous improvement initiatives across our operational landscape. The Associate will be tasked with developing and implementing real-time monitoring tools and dashboards, utilizing platforms like JMP, R, Python, and MATLAB. These tools will be critical for monitoring batch release and stability data, enabling proactive identification of trends and potential issues.
• • Furthermore, the role demands the construction of predictive models and the execution of large-scale data analyses. This analytical rigor will empower data-driven decision-making across all operational facets, moving us towards a more predictive and efficient operational model. The incumbent will be a key player in fostering innovation by actively exploring and championing the adoption of cutting-edge data and technology methodologies from the broader data science community. The goal is to identify emerging opportunities and capabilities that can be strategically implemented within the organization to achieve operational excellence and enhance overall efficiency.
• • This position will also provide crucial support for the analytical release and stability testing of both drug substance and drug product materials, often in collaboration with external contract testing laboratories. A significant aspect of the role involves contributing to the authoring, meticulous review, and diligent maintenance of internal and external quality documents, ensuring unwavering compliance with stringent regulatory standards and guidelines.
• • The Associate will play a supportive role in regulatory filings, contributing to the preparation, review, and compilation of analytical data summaries, comprehensive reports, and essential supporting documentation required for regulatory submissions. This requires a keen understanding of regulatory requirements and the ability to present complex data in a clear and compliant manner.
• • Success in this role hinges on a strong foundational understanding of statistical analysis, sophisticated data visualization techniques, and robust data management practices. Proficiency in analytical tools and a solid grasp of data architecture principles are essential for effectively supporting analytical and operational decision-making processes.
• • The ideal candidate will possess exceptional organizational skills, a strategic mindset, and the proven ability to meticulously execute detailed tasks while maintaining a clear vision of the broader objectives. Excellent communication skills are paramount, enabling the translation of complex analytical findings into clear, actionable insights for diverse audiences, including both technical experts and non-technical stakeholders. The capacity to collaborate effectively across cross-functional teams, adeptly manage multiple competing priorities, and maintain an unwavering commitment to a high level of attention to detail are critical attributes for success in this dynamic environment.
• • We are looking for individuals skilled at identifying potential opportunities for improvement and applying detail-oriented, yet impactful, solutions to achieve significant outcomes. The role demands a blend of organized execution and strategic foresight, enabling the balancing of day-to-day responsibilities with long-term goals.
• • This is a remote position, offering flexibility while requiring dedication to our mission of advancing healthcare through innovative pharmaceutical solutions.