Otsuka America Pharmaceutical Inc.
Associate Director, MSAT, Upstream
Otsuka America Pharmaceutical Inc., Indianapolis, Indiana, us, 46262
Position Overview
We are seeking a highly skilled and experienced professional to join our organization as the Assoc. Director of Manufacturing Science and Technology (MSAT) for Upstream processes. This critical role will lead our efforts in developing, optimizing, and scaling up upstream bioprocesses for the commercial production of biologics. This role is responsible for ensuring the robustness, scalability, and compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted by external partners. Responsibilities
Lead the upstream development, fostering a culture of scientific excellence, innovation, and continuous improvement Serve as the primary technical subject matter expert (SME) for upstream processing (cell culture/fermentation, harvest) Lead and manage the technical aspects of upstream process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment Provide expert technical oversight of upstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls Lead or significantly contribute to troubleshooting efforts and root cause investigations for upstream process deviations or performance issues at CDMOs Analyze upstream process data (via CPV program, campaign summaries) to monitor performance, identify trends, and propose process improvements Support process characterization and validation activities (PPQ) for upstream processes executed at CDMOs Evaluate and manage the implementation of upstream process changes and improvements post-approval Author and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory, Process Development, and CDMO technical teams Stay current with advancements in upstream processing technologies, analytics, and regulatory expectations Qualifications
Ph.D. in Biochemical Engineering, Biotechnology, or a related field Minimum 8-10+ years of relevant experience in the biopharmaceutical industry with a strong focus on biologics upstream process development, scale-up, technology transfer, and/or manufacturing sciences/support Proven track record in leading upstream process development and scale-up activities Deep understanding of cell culture techniques, bioreactor operations, and cell line development Strong knowledge of cGMP regulations and ICH guidelines relevant to upstream biologics manufacturing Experience with a variety of expression systems (e.g., CHO, HEK293, microbial) Familiarity with Quality by Design (QbD) principles and their application to upstream processes Excellent leadership skills with the ability to mentor and develop team members Strong analytical and problem-solving skills, with a data-driven approach to decision-making Outstanding communication and interpersonal skills, able to influence stakeholders at all levels Experience in managing complex projects and driving process 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 $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline
This will be posted for a minimum of 5 business days. 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. EEO Statement
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. Reasonable accommodations are available for qualified individuals with disabilities or disabled veterans upon request. To ensure legitimate opportunities, only apply through official Otsuka career channels; Otsuka will not ask for financial information or payments during the application process. For security, please verify you are interacting with official Otsuka communications.
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We are seeking a highly skilled and experienced professional to join our organization as the Assoc. Director of Manufacturing Science and Technology (MSAT) for Upstream processes. This critical role will lead our efforts in developing, optimizing, and scaling up upstream bioprocesses for the commercial production of biologics. This role is responsible for ensuring the robustness, scalability, and compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted by external partners. Responsibilities
Lead the upstream development, fostering a culture of scientific excellence, innovation, and continuous improvement Serve as the primary technical subject matter expert (SME) for upstream processing (cell culture/fermentation, harvest) Lead and manage the technical aspects of upstream process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment Provide expert technical oversight of upstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls Lead or significantly contribute to troubleshooting efforts and root cause investigations for upstream process deviations or performance issues at CDMOs Analyze upstream process data (via CPV program, campaign summaries) to monitor performance, identify trends, and propose process improvements Support process characterization and validation activities (PPQ) for upstream processes executed at CDMOs Evaluate and manage the implementation of upstream process changes and improvements post-approval Author and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory, Process Development, and CDMO technical teams Stay current with advancements in upstream processing technologies, analytics, and regulatory expectations Qualifications
Ph.D. in Biochemical Engineering, Biotechnology, or a related field Minimum 8-10+ years of relevant experience in the biopharmaceutical industry with a strong focus on biologics upstream process development, scale-up, technology transfer, and/or manufacturing sciences/support Proven track record in leading upstream process development and scale-up activities Deep understanding of cell culture techniques, bioreactor operations, and cell line development Strong knowledge of cGMP regulations and ICH guidelines relevant to upstream biologics manufacturing Experience with a variety of expression systems (e.g., CHO, HEK293, microbial) Familiarity with Quality by Design (QbD) principles and their application to upstream processes Excellent leadership skills with the ability to mentor and develop team members Strong analytical and problem-solving skills, with a data-driven approach to decision-making Outstanding communication and interpersonal skills, able to influence stakeholders at all levels Experience in managing complex projects and driving process 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 $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline
This will be posted for a minimum of 5 business days. 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. EEO Statement
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. Reasonable accommodations are available for qualified individuals with disabilities or disabled veterans upon request. To ensure legitimate opportunities, only apply through official Otsuka career channels; Otsuka will not ask for financial information or payments during the application process. For security, please verify you are interacting with official Otsuka communications.
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