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BioMarker Operations Manager

2 months ago

Bridgewater, United States eTeam Full time

Job title:- Outsourcing Manager/BioMarker Operations Manager

Location:- Bridgewater, NJ-Hybrid onsite twice a week, flexible days

Work Schedule 9-5 EST; Mon - Fri

Duration:- 12 Months

Pay Rate: $70.00- $75.00/hr on W2


Must-Have Skills:

Education: open to all degrees (BA/MA/PhD) in Chemistry, Biochemistry, Biology, Molecular Biology • Work Experience: 5 years minimum of industry • Must-Have Experience with: biotech, bio analytics, bio analysis regulations, bio markers, pharmaceuticals, GLP/GCLP


Job Description:

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, provide 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, ensure timely delivery of quality results in compliance with regulations.