Otsuka Pharmaceutical Co., Ltd
Associate Director, Bioanalysis
Otsuka Pharmaceutical Co., Ltd, Princeton, New Jersey, us, 08543
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.**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.**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.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; .**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.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.**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.Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. #J-18808-Ljbffr
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.**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.**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.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; .**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.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.**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.Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. #J-18808-Ljbffr