Bench Scientist

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Job description

Position Details:

Our client, a world-leading Pharmaceutical Company in La Jolla, CA is currently looking for a Oncology Biomarker Assay Specialist to join their expanding team.

Job Title: Oncology Biomarker Assay Specialist / Hybrid Work

Duration: 12 months contract, extendable up to 36 months

Location: La Jolla, CA

This is a hybrid role in La Jolla, CA; candidates must report onsite 2-3 days per week

Note:

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the company group medical insurance plan

Job Description:

Biomarker Operational Specialist

Summary:

As a member of the Biomarker Clinical Assay and Technology (BCAT) group within the client Oncology Division, you will play a critical role in supporting Translational Oncology strategies through operational and technical assistance for the Biomarker Clinical Assay Lead (BCAL) overseeing and managing external and internal partners involved in the implementation of clinical trial biomarkers sample analyses.

Responsibilities:

Support Biomarker Clinical Assay Lead (BCAL) by providing document management and process management support

Distribute documents to vendors, track distribution and acknowledgement/response from vendors

Create and maintain master document list for closeout studies

Enter vendor and bioanalytical report information into BCAT systems

Keep track of vendor assay validations, biomarker assay reports and sample disposition documents

Request regular updates to vendor contact information

Assist with Vendor Evaluation data collection

Maintain and track vendor qualification and oversight documentation

Submission of documents to global document management system (GDMS) Report Loading Team

Support BCAL in operational oversight for their supported studies

Track vendor Master Service Agreement (MSA) expiration dates, vendor contact information, Vendor Oversight Plan (VOP) status, CLIA status, QMSO9 status, CP102 status, and qualification/audit visits

Work with Pharmaceutical Trial Master File (PTMF) study owners to ensure proper attributes and functional line information is accurate for all BCAT documents loaded to PTMF

Qualifications:

Bachelor's degree or Master's degree in biology, molecular biology, biotechnology, or biochemistry

A minimum of 2+ years of related clinical or research lab experience

Proficiency in Microsoft Office and Communication tools, including Cloud-based services

Experience with project management tools and Vizio experience

Attention to detail and ability to think and act proactively is critical

Demonstrated ability to work in a highly matrixed environment, and execute multiple projects simultaneously

Good understanding of inter-dependencies and functional line responsibilities

Schedule:

This is a hybrid role in La Jolla, CA; candidates must report onsite 2-3 days per week

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