Otsuka America Pharmaceutical Inc.
Associate Director, MSAT, Downstream Drug Substance
Otsuka America Pharmaceutical Inc., Lincoln, Nebraska, United States, 68511
Job Summary
Job Summary
- The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes for the company\'s biologics portfolio executed at CDMOs. This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted by external partners. Key Responsibilities
Serve as the primary technical subject matter expert (SME) for downstream processing (chromatography, TFF/UFDF, viral clearance/filtration, etc.). Lead and manage the technical aspects of downstream process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. Provide expert technical oversight of downstream 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 downstream process deviations or performance issues at CDMOs. Analyze downstream process data (via CPV program, campaign summaries) to monitor performance, identify trends, and propose process improvements. Support process characterization and validation activities (PPQ) for downstream processes executed at CDMOs. Evaluate and manage the implementation of downstream 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 downstream processing. Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory, Process Development, Analytical Development, and CDMO technical teams. Stay current with advancements in downstream processing technologies, analytics, and regulatory expectations. Qualifications
Degree (Ph.D. preferred, MS/BS considered with extensive experience) in Chemical Engineering, Biochemical Engineering, Biochemistry, or related life sciences field. Minimum 8-10+ years of relevant experience in the biopharmaceutical industry with a strong focus on biologics downstream process development, scale-up, technology transfer, and/or manufacturing sciences/support. Significant experience providing technical oversight for biologics downstream processes manufactured at CDMOs is highly desirable. In-depth technical knowledge of purification techniques (various chromatography modes, TFF/UFDF), viral clearance strategies, filtration, and potentially formulation/fill-finish operations. Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). Familiarity with process validation principles and CPV. Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). Excellent communication, collaboration, and influencing skills. Ability to work effectively in a fast-paced, virtual environment. Travel Requirements:
Approximately 15-25% travel required (domestic and potentially international) to CDMO sites 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. Salary Range:
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 Details
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). Fraud Warning
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. If you suspect a position is fraudulent, please contact Otsuka’s call center at 800-363-5670 or the FBI IC3 site at https://www.ic3.gov. Otsuka will not accept unsolicited assistance from search firms for employment opportunities. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
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Job Summary
- The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes for the company\'s biologics portfolio executed at CDMOs. This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted by external partners. Key Responsibilities
Serve as the primary technical subject matter expert (SME) for downstream processing (chromatography, TFF/UFDF, viral clearance/filtration, etc.). Lead and manage the technical aspects of downstream process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. Provide expert technical oversight of downstream 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 downstream process deviations or performance issues at CDMOs. Analyze downstream process data (via CPV program, campaign summaries) to monitor performance, identify trends, and propose process improvements. Support process characterization and validation activities (PPQ) for downstream processes executed at CDMOs. Evaluate and manage the implementation of downstream 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 downstream processing. Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory, Process Development, Analytical Development, and CDMO technical teams. Stay current with advancements in downstream processing technologies, analytics, and regulatory expectations. Qualifications
Degree (Ph.D. preferred, MS/BS considered with extensive experience) in Chemical Engineering, Biochemical Engineering, Biochemistry, or related life sciences field. Minimum 8-10+ years of relevant experience in the biopharmaceutical industry with a strong focus on biologics downstream process development, scale-up, technology transfer, and/or manufacturing sciences/support. Significant experience providing technical oversight for biologics downstream processes manufactured at CDMOs is highly desirable. In-depth technical knowledge of purification techniques (various chromatography modes, TFF/UFDF), viral clearance strategies, filtration, and potentially formulation/fill-finish operations. Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). Familiarity with process validation principles and CPV. Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). Excellent communication, collaboration, and influencing skills. Ability to work effectively in a fast-paced, virtual environment. Travel Requirements:
Approximately 15-25% travel required (domestic and potentially international) to CDMO sites 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. Salary Range:
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 Details
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). Fraud Warning
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. If you suspect a position is fraudulent, please contact Otsuka’s call center at 800-363-5670 or the FBI IC3 site at https://www.ic3.gov. Otsuka will not accept unsolicited assistance from search firms for employment opportunities. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
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