Otsuka America Pharmaceutical Inc.
Senior Director, MSAT Biologics
Otsuka America Pharmaceutical Inc., Dover, Delaware, United States, 19904
Overview
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 builds and leads the MSAT team, ensuring robust and compliant manufacturing processes through technology transfer, validation, process monitoring, and lifecycle management. This individual serves as the primary technical steward for manufacturing processes and collaborates with internal functions and external partners. Responsibilities
Develop and implement the overall MSAT strategy supporting the portfolio, focusing on technical oversight of CDMO manufacturing operations. Build, lead, mentor, and manage the MSAT team, fostering 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. Compensation and Benefits
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity. The range shown represents a typical pay range 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. Additional Information
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka Disclaimer & Equal Opportunity
This job description is intended to describe the general nature and level of work performed by the people assigned to this position. Otsuka is an equal opportunity employer. All qualified applicants will be considered 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 require a reasonable accommodation to apply, please contact Accommodation Request (EEAccommodations@otsuka-us.com).
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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 builds and leads the MSAT team, ensuring robust and compliant manufacturing processes through technology transfer, validation, process monitoring, and lifecycle management. This individual serves as the primary technical steward for manufacturing processes and collaborates with internal functions and external partners. Responsibilities
Develop and implement the overall MSAT strategy supporting the portfolio, focusing on technical oversight of CDMO manufacturing operations. Build, lead, mentor, and manage the MSAT team, fostering 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. Compensation and Benefits
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity. The range shown represents a typical pay range 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. Additional Information
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka Disclaimer & Equal Opportunity
This job description is intended to describe the general nature and level of work performed by the people assigned to this position. Otsuka is an equal opportunity employer. All qualified applicants will be considered 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 require a reasonable accommodation to apply, please contact Accommodation Request (EEAccommodations@otsuka-us.com).
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