Senior Director, MSAT Biologics

Senior Director, MSAT Biologics

The Senior Director, MSAT Biologics provides strategic and technical leadership for all late-stage and commercial manufacturing processes for the company's biologics portfolio executed at CDMOs. This role is responsible for building and leading the MSAT team, ensuring robust and compliant manufacturing processes through effective technology transfer, validation, process monitoring, and lifecycle management. This individual will serve as the primary technical steward for manufacturing processes, ensuring strong collaboration between internal functions and external partners.

Key Responsibilities :

• Develop and implement the overall MSAT strategy supporting the company's portfolio, focusing on technical oversight of CDMO manufacturing operations.
• Build, lead, mentor, and manage the MSAT team, fostering a culture of scientific excellence, collaboration, and accountability.
• Provide senior technical leadership and oversight for technology transfer activities to new or existing CDMOs.
• Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards.
• Establish and oversee robust Continued Process Verification (CPV) programs for commercial products.
• Serve as the primary technical point of contact for CDMOs regarding process performance, troubleshooting, and improvements.
• Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs.
• Drive strategies for process optimization, yield improvement, and manufacturing cost reduction where appropriate.
• Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product lifecycle management.
• Lead root cause investigations for manufacturing deviations and implement corrective and preventive actions.
• Stay abreast of emerging trends and technologies in biologics manufacturing, recommending and implementing innovations where appropriate.
• Ensure compliance with cGMP regulations and other relevant quality standards.
• Represent the MSAT function in interactions with regulatory agencies and during audits.
• Manage budgets and resources effectively to meet departmental and organizational goals.

Qualifications :

Competencies :

Compensation : Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity : The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company Benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Disclaimer : This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com).

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