Associate Director, MSAT, Upstream

Position Overview:

We are seeking a highly skilled and experienced professional to join our organization as the Assoc. Director of Manufacturing Science and Technology (MSAT) for Upstream processes. This critical role will lead our efforts in developing, optimizing, and scaling up upstream bioprocesses for the commercial production of biologics. This role is responsible for ensuring the robustness, scalability, and compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted by external partners.

Key Responsibilities:

• Lead the upstream development, fostering a culture of scientific excellence, innovation, and continuous improvement
• Serve as the primary technical subject matter expert (SME) for upstream processing (cell culture/fermentation, harvest).
• Lead and manage the technical aspects of upstream process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment.
• Provide expert technical oversight of upstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls.
• Lead or significantly contribute to troubleshooting efforts and root cause investigations for upstream process deviations or performance issues at CDMOs.
• Analyze upstream process data (via CPV program, campaign summaries) to monitor performance, identify trends, and propose process improvements.
• Support process characterization and validation activities (PPQ) for upstream processes executed at CDMOs.
• Evaluate and manage the implementation of upstream process changes and improvements post-approval.
• Author and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing.
• Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory, Process Development, and CDMO technical teams.
• Stay current with advancements in upstream processing technologies, analytics, and regulatory expectations.

Qualifications:

• Ph.D. in Biochemical Engineering, Biotechnology, or a related field
• Minimum 8-10+ years of relevant experience in the biopharmaceutical industry with a strong focus on biologics upstream process development, scale-up, technology transfer, and/or manufacturing sciences/support.
• Proven track record in leading upstream process development and scale-up activities
• Deep understanding of cell culture techniques, bioreactor operations, and cell line development
• Strong knowledge of cGMP regulations and ICH guidelines relevant to upstream biologics manufacturing
• Experience with a variety of expression systems (e.g., CHO, HEK293, microbial)
• Familiarity with Quality by Design (QbD) principles and their application to upstream processes
• Excellent leadership skills with the ability to mentor and develop team members
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making
• Outstanding communication and interpersonal skills, able to influence stakeholders at all levels
• Experience in managing complex projects and driving process improvement initiatives

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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