Job Description

DIRECT HIRE

MUST HAVES:

• BS or MS in Immunology, Biochemistry, or a related scientific discipline with 5 or more years of relevant industry experience in a drug development setting
• In-depth understanding and hands-on experience developing quantitative analyte and anti-drug antibody (ADA) assays for protein therapeutics and/or gene therapies
• Antibody-drug conjugate (ADC) experience characterizing immune responses (Immunogenicity)

Position Overview

We are seeking a highly motivated and creative Scientist to lead the development of bioanalytical and biomarker methods. This role is pivotal in supporting our biopharmaceutical pipeline within the AAV oncology therapeutic area.

As a key member of the Non-clinical Development group, you will bridge the gap between early research and IND-enabling regulated studies, ensuring our novel therapies are supported by rigorous, state-of-the-art analytical data.

Key Responsibilities

In this role, you will be responsible for the technical execution of bioanalytical programs:

• Method Development: Develop, characterize, and validate in vitro assay methods to:
• Quantify transgene expression levels across various species and biological matrices.
• Detect and characterize immune responses (Immunogenicity) evoked by biotherapeutics (ADA, Luminex).
• Measure biomarkers and conduct biological characterization for regulatory filings.
• Sample Analysis: Implement bioanalytical methods in non-clinical studies and perform on-site sample testing
• Data Analysis: Analyze and interpret bioanalytical data, establish validated statistical cutpoints, and perform regression analysis to determine limits of detection or construct standard curves, interpolate sample concentrations and antibody titers
• Timeline Management: Develop and manage timelines and resources to ensure project goals are met with precision.
• Mentorship: Supervise and mentor other team members, fostering a culture of technical excellence.
• Cross-Functional Collaboration: Work independently and alongside colleagues across various functional areas to support both research and regulated clinical studies.
• CRO management: Work with external partners to develop and validate outsourced bioanalytical methods for GLP-regulated studies.

Who You Are

We are looking for a collaborator who thrives in a rigorous, entrepreneurial environment. You are someone who balances scientific curiosity with the disciplined execution required to bring medicines to patients.

Required Qualifications :

• Education: BS or MS in Immunology, Biochemistry, or a related scientific discipline.
• Experience: A minimum of 5 years of relevant industry experience in a drug development setting
• Technical Mastery: In-depth understanding and hands-on experience developing quantitative analyte and anti-drug antibody (ADA) assays for protein therapeutics and/or gene therapies
• Platform Expertise: Proficiency with state-of-the-art technologies such as MSD, ELISpot, and Luminex.
• Communication: Excellent interpersonal and organizational skills, with a proven track record of solving complex bioanalytical problems.

Preferred Qualifications :

• Specific expertise with AAV therapeutic development
• Familiarity with database and data archival software systems.

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