Otsuka America Pharmaceutical Inc.
Senior Director, MSAT Biologics
Otsuka America Pharmaceutical Inc., Springfield, Illinois, us, 62777
Position Overview
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
Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field
Minimum 15 years of experience in biologics manufacturing, with at least 5 years in a senior leadership role
Deep understanding of upstream and downstream bioprocessing, including cell culture, purification, and formulation
Proven track record in process development, scale-up, and technology transfer of biologics products
Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing
Experience with PAT (Process Analytical Technology) and QbD (Quality by Design) principles
Excellent leadership and team management skills, with the ability to motivate and develop staff
Strong analytical and problem-solving skills, with a data-driven approach to decision-making
Outstanding communication skills, both written and verbal, with the ability to influence at all levels of the organization
Experience in managing complex projects and driving continuous 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. 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. Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka . 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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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
Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field
Minimum 15 years of experience in biologics manufacturing, with at least 5 years in a senior leadership role
Deep understanding of upstream and downstream bioprocessing, including cell culture, purification, and formulation
Proven track record in process development, scale-up, and technology transfer of biologics products
Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing
Experience with PAT (Process Analytical Technology) and QbD (Quality by Design) principles
Excellent leadership and team management skills, with the ability to motivate and develop staff
Strong analytical and problem-solving skills, with a data-driven approach to decision-making
Outstanding communication skills, both written and verbal, with the ability to influence at all levels of the organization
Experience in managing complex projects and driving continuous 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. 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. Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka . 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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