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.
