Tech Stack

Description

You will lead the development and qualification of innovative bioanalytical assays to support immunogenicity risk assessments, biomarker measurements, and clinical pharmacology deliverables for genetic medicines. You will work cross-functionally to inform key program decisions and contribute to a portfolio of targeted therapies.

Requirements

• PhD in immunology, bioengineering, molecular biology, cell biology, pharmacology, biochemistry or related field with 3+ years industry/academic experience; or Master's with 5+; or Bachelor's with 7+.
• Bioanalytical and/or biomarker assay development experience strongly preferred.
• Experience leading anti-drug antibody assay development, qualification, and validation in a regulated environment.
• Experience with PCR, qPCR, droplet digital PCR, RNA-seq, and tissue culture.
• Familiarity with ligand binding assays and LC-MS is a plus.
• Late-stage clinical trial and CRO oversight experience are a plus.
• Working knowledge of clinical pharmacology concepts preferred.
• Competence in microplate readers, Meso Scale Discovery, PCR primer/probe design, and protein techniques.
• Ability to independently design and execute new assay methods and provide technical leadership.
• Strong attention to detail, data analysis, and documentation skills.
• Demonstrated ability to influence cross-functional decisions and communicate effectively.

Responsibilities

• Provide scientific and technical leadership in developing and qualifying bioanalytical assays, including ligand-binding, anti-drug antibody, cell-based, and molecular assays.
• Lead assay lifecycle activities from method development through implementation, defining performance criteria and resolving technical issues.
• Oversee GxP workflows and ensure data integrity and inspection readiness.
• Design and execute experiments, analyze data, and communicate conclusions to management and study teams.
• Contribute to in vivo and in vitro study design and biomarker strategy.
• Select and manage CROs for external assay development and validation.
• Partner with clinical teams to define bioanalytical strategy supporting PK/PD and dose selection.
• Review bioanalytical datasets for quality and consistency; summarize findings for study teams.
• Author or review clinical and regulatory documents related to PK/PD and immunogenicity.
• Mentor junior staff in experimental design and data interpretation.
• Maintain awareness of scientific literature and propose improvements.
• Write reports and manuscripts, present at meetings.
• Ensure compliance with company EHS policies.
• Contribute to a culture of innovation and continuous improvement.