Remote: Bioanalysis Strategy Lead – PK & Biomarkers

Otsuka America Pharmaceutical Inc.; Columbia (SC); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

Prescription drug coverage

401(k) match

Paid holidays & leave

Tuition reimbursement & student loan‑a

Job summary

Otsuka America Pharmaceutical Inc. seeks a highly motivated Associate Director, Bioanalysis to provide strategic oversight of outsourced bioanalytical activities for clinical development, with a primary focus on pharmacokinetics and biomarkers.

The role leads method development, validation, and troubleshooting, collaborating with CROs and cross‑functional teams to ensure audit‑ready and submission‑ready data, while evaluating emerging technologies and driving process improvements.

Qualifications

• Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or M.S. or B.S. with a minimum of 8 years of relevant industry experience.
• Demonstrated expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic and biomarker assays.
• Strong knowledge of global bioanalytical regulatory guidance and industry standards.
• Hands‑on experience with LC‑MS/MS, ELISA, ECL, flow cytometry, and other platforms.
• Experience with immunogenicity assays (ADA/NAb) is a plus.
• Experience managing CROs and external partnerships, including oversight of deliverables, budgets, timelines, quality, and compliance.
• Strong project management, communication, and cross‑functional collaboration skills.

Responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.
• Oversee method development, qualification, validation, and sample analysis with troubleshooting and optimization.
• Develop and maintain partnerships with bioanalytical CROs and external vendors.
• Monitor vendor performance to ensure timelines, quality, and regulatory compliance.
• Ensure activities follow global regulatory guidance and industry best practices.
• Serve as SME on cross‑functional teams, providing recommendations and risk assessments.
• Support regulatory submissions by contributing to and reviewing documents and responses.

Skills

PK assays

Biomarker assays

LC-MS/MS

ELISA

ECL

Flow cytometry

ADA/NAb assays

CRO management

Project management

Regulated bioanalysis

Education

Ph.D.

MS/BS with 8+ years experience

Job description

Otsuka America Pharmaceutical Inc. seeks a highly motivated Associate Director, Bioanalysis to provide strategic oversight of outsourced bioanalytical activities for clinical development, with a primary focus on pharmacokinetics and biomarkers.

The role leads method development, validation, and troubleshooting, collaborating with CROs and cross‑functional teams to ensure audit‑ready and submission‑ready data, while evaluating emerging technologies and driving process improvements.