Bioanalytical Scientist: PK/LBA Method Transfer

BioSpace; Washington (District of Columbia); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Retirement plan

Bonus program

Stock incentives

Paid time off

Flexible work model

Job summary

Amgen in Washington, DC seeks a Scientist, Bioanalytical Sciences to oversee outsourced bioanalytical work, ensuring validation and performance at CROs. The role covers PK/TK analyses and regulatory alignment across studies.

The candidate will drive method development, transfer, and troubleshooting with CRO partners, ensuring data integrity and robust scientific quality in GLP/GCP contexts.

Qualifications

• PhD/MD or equivalent with relevant post-doc experience preferred.
• Experience leading PK/TK bioanalytical method development and transfer.
• Familiarity with GLP/GCP and regulatory expectations for outsourced bioanalysis.

Responsibilities

• Oversee transfer, validation and execution of PK assays at CROs.
• Provide scientific and technical oversight of bioanalytical activities (PK/TK) per GLP/GCP.
• Ensure data integrity and regulatory compliance across studies.
• Collaborate with internal SMEs and CROs to troubleshoot and improve assays.

Skills

PK assay development

LC-MS bioanalysis

ELISA / ECL / LBA

Regulatory knowledge (FDA/ICH/EMEA/NMP

CRO collaboration

Communication skills

Education

Doctorate degree in relevant field

Master’s degree + 2 years regulated lab experience

Bachelor’s degree + 4 years regulated lab experience

Tools

LC-MS/MS

ELISA

ECL

Job description

Amgen in Washington, DC seeks a Scientist, Bioanalytical Sciences to oversee outsourced bioanalytical work, ensuring validation and performance at CROs. The role covers PK/TK analyses and regulatory alignment across studies.

The candidate will drive method development, transfer, and troubleshooting with CRO partners, ensuring data integrity and robust scientific quality in GLP/GCP contexts.