Senior Bioanalysis Lead: PK & Biomarkers (Remote)

Otsuka America Pharmaceutical Inc.; Carson City (NV); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. in the United States seeks an Associate Director of Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical programs, with a focus on PK and biomarkers.

You will lead assay strategy, method development, validation, and troubleshooting, manage CRO relationships, ensure audit-ready data, and drive adoption of emerging technologies to improve data quality across development.

Qualifications

• Ph.D. with 5+ years in regulated bioanalysis or MS/biomarker assays.
• Deep expertise in PK and biomarker workflows.
• Strong knowledge of global regulatory guidance.
• Experience managing CROs and external partnerships.

Responsibilities

• Provide strategic leadership for outsourced bioanalytical activities.
• Oversee method development, validation, and data review.
• Collaborate with CROs to ensure timeliness and quality.
• Support regulatory submissions and inspection readiness.

Skills

Pharmacokinetics

Biomarkers

Regulated bioanalysis

Mass spectrometry

LBA

Cell-based assays

Education

PhD in Bioanalytical Sciences

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Job description

Otsuka America Pharmaceutical Inc. in the United States seeks an Associate Director of Bioanalysis to provide strategic and scientific oversight of outsourced bioanalytical activities supporting clinical programs, with a focus on PK and biomarkers.

You will lead assay strategy, method development, validation, and troubleshooting, manage CRO relationships, ensure audit-ready data, and drive adoption of emerging technologies to improve data quality across development.