Job Summary: The Associate Director, Downstream Drug Substance MSAT provides essential technical leadership for all downstream manufacturing processes within the company's biologics portfolio. You will play a critical role in ensuring the effectiveness, scalability, and regulatory compliance of downstream operations through adept technology transfer, validation support, and process management in collaboration with external partners. Key Responsibilities: Act as the primary technical subject matter expert (SME) for downstream processes, including chromatography, TFF/UFDF, and viral clearance. Lead the technical management of downstream process technology transfers to CDMOs, including thorough documentation review and risk assessments. Provide expert oversight of downstream manufacturing at CDMOs, ensuring accuracy in batch records, deviation investigations, and change controls. Drive troubleshooting efforts and root cause analyses for any downstream process deviations or performance concerns at CDMOs. Evaluate downstream process data to monitor performance, identify trends, and recommend process enhancements. Support process characterization and validation activities for downstream operations executed at CDMOs. Assess and manage downstream process changes and improvements post-approval. Prepare and review technical reports, protocols, and sections of regulatory submissions (IND, BLA, MAA) related to downstream processing. Collaborate with Upstream MSAT, Validation MSAT, QA, Regulatory, Process Development, Analytical Development, and CDMO technical teams. Stay updated with advancements in downstream processing technologies and regulatory expectations. Qualifications: Advanced degree (Ph.D. preferred, MS/BS considered with extensive relevant experience) in Chemical Engineering, Biochemical Engineering, Biochemistry, or related life sciences field. 8-10+ years of relevant biopharmaceutical industry experience, focusing on downstream process development and technical support. Experience in providing technical oversight for biologics downstream processes at CDMOs is a strong advantage. In-depth knowledge of purification techniques, viral clearance strategies, and cGMP regulations. Strong analytical and problem-solving skills, including statistical analysis knowledge. Exceptional communication, collaboration, and influencing abilities. Ability to thrive in a fast-paced, virtual working environment. Travel Requirements: Approximately 15-25% travel required (domestic and potentially international) to CDMO sites. Competencies: Accountability for Results: Maintain focus on strategic objectives and uphold high-performance standards. Strategic Thinking & Problem Solving: Make decisions with long-term impacts for customers and the business in mind. Patient & Customer Centricity: Prioritize the needs of customers and stakeholders. Impactful Communication: Convey information clearly and respectfully, influencing others positively. Respectful Collaboration: Value diverse perspectives and foster partnerships towards common goals. Empowered Development: Engage actively in professional development as a business necessity. Discover more about Otsuka and our benefits.