Associate Director, MSAT, Downstream Drug Substance

Associate Director, MSAT - Downstream

The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes for the company's biologics portfolio executed at CDMOs. This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted by external partners.

Key Responsibilities

• Serve as the primary technical subject matter expert (SME) for downstream processing (chromatography, TFF / UFDF, viral clearance / filtration, etc.).
• Lead and manage the technical aspects of downstream process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment.
• Provide expert technical oversight of downstream 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 downstream process deviations or performance issues at CDMOs.
• Analyze downstream process data (via CPV program, campaign summaries) to monitor performance, identify trends, and propose process improvements.
• Support process characterization and validation activities (PPQ) for downstream processes executed at CDMOs.
• Evaluate and manage the implementation of downstream 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 downstream processing.
• Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory, Process Development, Analytical Development, and CDMO technical teams.
• Stay current with advancements in downstream processing technologies, analytics, and regulatory expectations.

Qualifications

Degree (Ph.D. preferred, MS / BS considered with extensive experience) in Chemical Engineering, Biochemical Engineering, Biochemistry, or related life sciences field. Minimum 8-10+ years of relevant experience in the biopharmaceutical industry with a strong focus on biologics downstream process development, scale-up, technology transfer, and / or manufacturing sciences / support. Significant experience providing technical oversight for biologics downstream processes manufactured at CDMOs is highly desirable. In-depth technical knowledge of purification techniques (various chromatography modes, TFF / UFDF), viral clearance strategies, filtration, and potentially formulation / fill-finish operations. Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). Familiarity with process validation principles and CPV. Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). Excellent communication, collaboration, and influencing skills. Ability to work effectively in a fast-paced, virtual environment.

Travel Requirements

Approximately 15-25% travel required (domestic and potentially international) to CDMO sites

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.