Research Assistant, Cancer Companion Diagnostics

Responsibilities

• Supporting Stability Research Associates in the planning, execution, and documentation of stability studies for Companion Diagnostic (CDx) assays and assays in feasibility.
• Performing laboratory activities in accordance with Quality Management System (QMS), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP) requirements.
• Preparing, organizing, labeling, tracking, and maintaining study samples, reagents, supplies, and laboratory records.
• Assisting with the execution of stability studies, including reagent stability, cut section stability, stained slide stability, and related studies.
• Maintaining accurate and traceable laboratory documentation using electronic lab notebook system and controlled forms.
• Recording experimental observations, collecting data, and communicating study progress, issues, and observations to the assigned Study Responsible and broader team.
• Supporting multiple studies simultaneously while maintaining organization, accuracy, and attention to detail.
• Following established procedures, protocols, and work instructions while recognizing and escalating discrepancies, unexpected results, or quality concerns.
• Assisting with laboratory organization, inventory management, and other operational tasks that support study execution.
• Collaborating with Stability team members and cross-functional partners to support project deliverables and timelines.
• Contributing to continuous improvement efforts, including updates to templates, workflows, documentation tools, and knowledge repositories.
• Participating in project team meetings to provide study updates and communicate laboratory observations.
• May assist with data analysis, preparation of study summaries, protocol development, report generation, or presentation materials under the guidance of a Research Associate/Study Responsible.
• Maintaining technical knowledge through training, scientific literature review, and participation in team learning activities.

Qualifications

• BS/BA or MA in Biology, Biochemistry or related field.
• Ability to follow Quality System regulations including Design Control.
• Experience with immunohistochemistry and microscopy.
• Demonstrated problem-solving skills.
• Detail-oriented and organizational skills.
• Analytical skills and creativity.
• Proficient with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work both independently and within a team setting.