Otsuka America Pharmaceutical Inc.
Associate Director, MSAT, Upstream
Otsuka America Pharmaceutical Inc., Juneau, Alaska, us, 99812
Overview
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:
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. 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. 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. 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) . Security & Fraud Notice
Statement Regarding Job Recruiting Fraud Scams: At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Otsuka will never ask for financial information or payment during the job application process. We will also not offer you money to buy equipment or for any other purpose during the job application process. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are a victim of fraud, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities. Otsuka will not be held liable for claims, losses, damages or expenses resulting from job recruiting scams. For legitimate opportunities, please apply through the official Otsuka Career website: https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
#J-18808-Ljbffr
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:
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. 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. 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. 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) . Security & Fraud Notice
Statement Regarding Job Recruiting Fraud Scams: At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Otsuka will never ask for financial information or payment during the job application process. We will also not offer you money to buy equipment or for any other purpose during the job application process. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are a victim of fraud, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities. Otsuka will not be held liable for claims, losses, damages or expenses resulting from job recruiting scams. For legitimate opportunities, please apply through the official Otsuka Career website: https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
#J-18808-Ljbffr