Join our dynamic team as the Associate Director of Manufacturing Science and Technology (MSAT) for Upstream processes. In this key position, you will play a pivotal role in developing, optimizing, and scaling up upstream bioprocesses for the commercial production of biologics. Your expertise will ensure that our upstream operations are robust, compliant, and scalable through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted alongside our external partners. Key Responsibilities: Lead and innovate upstream development to foster scientific excellence and continuous improvement. Act as the primary technical expert in upstream processing including cell culture, fermentation, and harvest. Oversee technical aspects of upstream process technology transfers to CDMOs, ensuring thorough documentation review and risk assessment. Provide technical oversight for upstream manufacturing operations at CDMOs, including batch record reviews and investigation of deviations. Contribute to troubleshooting efforts and root cause analyses for upstream process deviations and performance issues. Utilize data analytics to monitor performance and propose continuous process improvements. Support process characterization and validation activities executed at CDMOs. Evaluate and manage post-approval implementation of upstream process changes and enhancements. Author and review technical reports, protocols, and regulatory submission sections related to upstream processes. Collaborate effectively with cross-disciplinary teams including Downstream MSAT, QA, Regulatory, and Process Development. Stay informed about advancements in upstream processing technologies and regulatory expectations. Qualifications: Ph.D. in Biochemical Engineering, Biotechnology, or a related discipline. 8-10+ years of experience within the biopharmaceutical sector focused on upstream process development and technology transfer. Demonstrated leadership in upstream process development and scalability. In-depth knowledge of cell culture techniques and bioreactor operations. Strong understanding of cGMP regulations and ICH guidelines relevant to biologics manufacturing. Familiarity with various expression systems, including CHO and HEK293. Experience with Quality by Design (QbD) principles in upstream processes. Exceptional leadership abilities, with a commitment to mentoring and team development. Strong analytical skills with a proactive, data-driven approach to problem-solving. Exceptional communication skills, able to engage with stakeholders at all levels. Proven ability to manage complex projects and effectively drive process improvement initiatives. Competencies: Accountability for Results: Focus on key objectives and uphold high performance standards. Strategic Thinking & Problem Solving: Make decisions that consider long-term impacts. Patient & Customer Centricity: Maintain focus on the needs of customers and stakeholders. Impactful Communication: Communicate with clarity and respect, influencing stakeholders effectively. Respectful Collaboration: Value diverse perspectives and work towards common goals. Empowered Development: Take an active role in personal and professional growth. We invite you to explore a career with us and discover more about our benefit offerings. Otsuka is an equal opportunity employer, welcoming applicants of all backgrounds and abilities. If you require reasonable accommodations due to a disability, please reach out to our accommodations team for assistance.