outsourcing manager/biomarker operations manager

$124,488 - $146,474/Yr

Randstad - Bridgewater Township, NJ

Full-time - Mid Level

Bridgewater Township, NJ

Administrative and Support Services

About the position

The Outsourcing Manager/Biomarker Operations Manager will act as the project manager to support the externalization and operationalization of clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development. This role involves managing budgets, overseeing bioanalysis, and ensuring compliance with regulations while collaborating with various teams to deliver quality results.

Responsibilities

• Act as the project manager to support the externalization and operationalization of clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development.
• Support the team on budget predictions, management, and tracking for a clear understanding of the biomarker operations and their impact on the project.
• Be the key point of contact for biomarker activities whether they are managed externally or internally to inform the team to make data-driven decisions.
• Oversee PK or ADA bioanalysis that is performed externally.
• Identify and help onboard vendors for specific analysis, providing advice and support on scientific and technical aspects of analysis where possible.
• Interact closely with Translational Medicine (TM) subteams to execute biomarker plans for clinical studies.
• Monitor assay development, assay validation, and sample analysis processes, ensuring timely delivery of quality results in compliance with regulations.

Requirements

• Education: Open to all degrees (BA/MA/PHD) in Chemistry, Biochemistry, Biology, Molecular Biology.
• Work Experience: Minimum of 5 years in the industry.
• Must-Have Experience with: Biotech, bio analytics, bio analysis regulations, biomarkers, pharmaceuticals, GLP/GCLP.

Nice-to-haves

• Project Management
• GLP (Good Laboratory Practice)
• GCP (Good Clinical Practice)

Benefits

• Health insurance
• Incentive and recognition program
• 401K contribution