Otsuka Pharmaceutical Companies (U.S.)
Associate Director, Bioanalysis
Otsuka Pharmaceutical Companies (U.S.), Princeton, New Jersey, us, 08543
Associate Director, Bioanalysis
– Otsuka Pharmaceutical Companies (U.S.)
Otsuka is looking for an energetic, motivated, and talented individual to join the Bioanalytical team. This role focuses on managing outsourced measurement in biological fluids to support clinical drug development, with emphasis on biological drug concentrations and immunogenicity. The Associate Director will develop and oversee methods, manage vendors, and support regulatory submissions, driving innovation in bioanalysis.
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, advocating for innovative solutions within project teams.
Qualifications / Requirements
Ph.D. with at least 3 years of relevant experience, or B.S. / M.S. with at least 5 years of relevant experience.
Proficient knowledge of regulated bioanalysis as defined by global guidances supporting 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 experience 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, interpersonal, written, and communication skills.
Employment Details Seniority level:
Mid‑Senior Level
Employment type:
Full‑time
Location:
South Plainfield, NJ
Salary Range:
$164,530.00 – $245,985.00 plus incentive opportunity
Benefits
Comprehensive medical, dental, vision, prescription drug coverage, basic life, accidental death & dismemberment, short‑term and long‑term disability insurance, tuition reimbursement, student loan assistance, generous 401(k) match, flexible time off, paid holidays, paid leave programs, and other company‑provided benefits.
Equal Opportunity 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.
#J-18808-Ljbffr
– Otsuka Pharmaceutical Companies (U.S.)
Otsuka is looking for an energetic, motivated, and talented individual to join the Bioanalytical team. This role focuses on managing outsourced measurement in biological fluids to support clinical drug development, with emphasis on biological drug concentrations and immunogenicity. The Associate Director will develop and oversee methods, manage vendors, and support regulatory submissions, driving innovation in bioanalysis.
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, advocating for innovative solutions within project teams.
Qualifications / Requirements
Ph.D. with at least 3 years of relevant experience, or B.S. / M.S. with at least 5 years of relevant experience.
Proficient knowledge of regulated bioanalysis as defined by global guidances supporting 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 experience 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, interpersonal, written, and communication skills.
Employment Details Seniority level:
Mid‑Senior Level
Employment type:
Full‑time
Location:
South Plainfield, NJ
Salary Range:
$164,530.00 – $245,985.00 plus incentive opportunity
Benefits
Comprehensive medical, dental, vision, prescription drug coverage, basic life, accidental death & dismemberment, short‑term and long‑term disability insurance, tuition reimbursement, student loan assistance, generous 401(k) match, flexible time off, paid holidays, paid leave programs, and other company‑provided benefits.
Equal Opportunity 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.
#J-18808-Ljbffr