Associate Director, Downstream Drug Substance MSAT - Otsuka America Pharmaceutical : Job Details

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.