Otsuka Pharmaceutical Co.
Otsuka is looking for an energetic, motivated, talented individual to join the Bioanalytical team. In addition to regulated bioanalysis, innovative measurement projects that focus on clinical trial outcomes and process improvement are just a part of what we invest our energy in. If you are looking for an opportunity to pioneer the field of bioanalysis, look no further.
The Associate Director, Bioanalysis is responsible for managing the outsourced measurement in biological fluids to support clinical drug development, with focus on biological drug concentrations and immunogenicity. He/she will have proficient knowledge in global bioanalytical guidance regulations and understanding of how bioanalytical data flows from the laboratory to regulatory submissions. Strong analytical experience, particularly with LBA, large molecule mass spectrometry, and cell‑based technologies, such as flow cytometry, as well as experience with vendor management is strongly preferred.
The individual will be responsible for managing vendors who generate bioanalytical data and ensuring data is auditable, submission‑ready and of high quality. He/she will contribute to method development problem solving and support data‑driven projects, such as biospecimen management. In addition, he/she will be responsible for surveying the clinical trial measurement landscape and make recommendations on process and technological improvements. The individual should maintain awareness of evolving trends in analytical techniques to support clinical trials and defend innovation projects to the project teams. This role requires excellent verbal and written communication skills, strong organizational skills, and the ability to manage multiple projects in different stages of development under strict deadlines and fluctuating priorities.
Key responsibilities
Provide strategic oversight for bioanalytical method development and validation, including troubleshooting and optimization.
Establish, cultivate, and manage relationships with contract research organizations (CROs) and external principal investigators.
Serve as a key contributor on project teams by presenting findings, interpreting scientific results, and recommending next steps or addressing issues.
Support regulatory submissions through drafting and reviewing submission‑ready reports.
Manage outsourced bioanalytical vendors to ensure adherence to timelines, data integrity, and compliance with global guidelines.
Ensure bioanalysis is conducted and reported in alignment with Global Bioanalytical Guidance for regulatory submissions supporting new chemical entities and biologics.
Oversee vendor activities, including review of analytical plans, validation strategies, and data packages.
Provide expert oversight of method performance and critically evaluate validation plans and reports.
Stay informed on emerging trends and technologies to advance bioanalytical capabilities, advocate for innovative solutions within project teams.
Qualifications / Required
PhD with at least 3 years of relevant experience, or B.S. or M.S. degree with at least 5 years of relevant experience.
Proficient knowledge of regulated bioanalysis as defined by global guidances in support of pharmacokinetics in drug development.
Solid understanding of bioanalytical methodology, including ELISA, ECL, flow cytometry, LC‑MS/MS, etc.
Large molecule bioanalysis experience required; small molecule is preferred.
Vendor management experience, specifically overseeing timelines, deliverables, conformity with contractual agreements, and regulatory compliance.
Demonstrated ability to work on multiple complex projects simultaneously with high attention to detail.
Team player with strong organizational, inter‑personal, written and communication skills.
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.
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, paid leave programs and other company‑provided benefits.
Career information Visit https://www.otsuka-us.com/careers-join-otsuka for more information about Otsuka and our benefit offerings.
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.
Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware that individuals may approach you and falsely present themselves as our employees or representatives. They may use this pretense to gain access to your personal information or attempt to acquire money from you through fictitious employment opportunities. Otsuka will never ask for financial information of any kind or for payment during the job application process. If you suspect a position is fraudulent, contact Otsuka’s call center at 800‑363‑5670 or reach out to the FBI through the Internet Crime Complaint Center at https://www.ic3.gov or your local authorities.
Equal Opportunity Employer 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. You can request reasonable accommodations by contacting Accommodation Request.
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The Associate Director, Bioanalysis is responsible for managing the outsourced measurement in biological fluids to support clinical drug development, with focus on biological drug concentrations and immunogenicity. He/she will have proficient knowledge in global bioanalytical guidance regulations and understanding of how bioanalytical data flows from the laboratory to regulatory submissions. Strong analytical experience, particularly with LBA, large molecule mass spectrometry, and cell‑based technologies, such as flow cytometry, as well as experience with vendor management is strongly preferred.
The individual will be responsible for managing vendors who generate bioanalytical data and ensuring data is auditable, submission‑ready and of high quality. He/she will contribute to method development problem solving and support data‑driven projects, such as biospecimen management. In addition, he/she will be responsible for surveying the clinical trial measurement landscape and make recommendations on process and technological improvements. The individual should maintain awareness of evolving trends in analytical techniques to support clinical trials and defend innovation projects to the project teams. This role requires excellent verbal and written communication skills, strong organizational skills, and the ability to manage multiple projects in different stages of development under strict deadlines and fluctuating priorities.
Key responsibilities
Provide strategic oversight for bioanalytical method development and validation, including troubleshooting and optimization.
Establish, cultivate, and manage relationships with contract research organizations (CROs) and external principal investigators.
Serve as a key contributor on project teams by presenting findings, interpreting scientific results, and recommending next steps or addressing issues.
Support regulatory submissions through drafting and reviewing submission‑ready reports.
Manage outsourced bioanalytical vendors to ensure adherence to timelines, data integrity, and compliance with global guidelines.
Ensure bioanalysis is conducted and reported in alignment with Global Bioanalytical Guidance for regulatory submissions supporting new chemical entities and biologics.
Oversee vendor activities, including review of analytical plans, validation strategies, and data packages.
Provide expert oversight of method performance and critically evaluate validation plans and reports.
Stay informed on emerging trends and technologies to advance bioanalytical capabilities, advocate for innovative solutions within project teams.
Qualifications / Required
PhD with at least 3 years of relevant experience, or B.S. or M.S. degree with at least 5 years of relevant experience.
Proficient knowledge of regulated bioanalysis as defined by global guidances in support of pharmacokinetics in drug development.
Solid understanding of bioanalytical methodology, including ELISA, ECL, flow cytometry, LC‑MS/MS, etc.
Large molecule bioanalysis experience required; small molecule is preferred.
Vendor management experience, specifically overseeing timelines, deliverables, conformity with contractual agreements, and regulatory compliance.
Demonstrated ability to work on multiple complex projects simultaneously with high attention to detail.
Team player with strong organizational, inter‑personal, written and communication skills.
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.
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, paid leave programs and other company‑provided benefits.
Career information Visit https://www.otsuka-us.com/careers-join-otsuka for more information about Otsuka and our benefit offerings.
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.
Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware that individuals may approach you and falsely present themselves as our employees or representatives. They may use this pretense to gain access to your personal information or attempt to acquire money from you through fictitious employment opportunities. Otsuka will never ask for financial information of any kind or for payment during the job application process. If you suspect a position is fraudulent, contact Otsuka’s call center at 800‑363‑5670 or reach out to the FBI through the Internet Crime Complaint Center at https://www.ic3.gov or your local authorities.
Equal Opportunity Employer 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. You can request reasonable accommodations by contacting Accommodation Request.
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