Bioanalytical Team Leader

Company Description

1E Therapeutics (1Etx) is an innovative drug development company specializing in creating first-in-class RNA-targeting therapeutics through its proprietary drug design platform.

Role Description

This is a full-time, on-site role located in Rehovot for a Bioanalytical Team Leader. We are seeking an experienced and dedicated Bioanalytical Team Leader to manage, mentor, and guide our Bioanalytical group. This pivotal role is responsible for leading the team that supports our drug discovery pipeline through IND-enabling studies. The ideal candidate will combine deep technical expertise in the analysis of therapeutic oligonucleotides and delivery systems with strong, hands-on leadership skills. You will be responsible for driving projects, managing CROs, and developing your team in a dynamic, fast-paced startup environment.

Key Responsibilities

• Lead, mentor, and manage the Bioanalytical team, fostering a culture of high performance, scientific excellence, and professional growth.
• Direct the development, optimization, and validation of robust bioanalytical methods for the quantification of oligonucleotides, lipids, and LNP formulations in various biological matrices.
• Lead the development and implementation of advanced characterization methods for Lipid Nanoparticles (LNPs) and liposomal formulations, including stability.
• Act as the primary point of contact for external bioanalytical CROs; lead activities from selection and qualification through managing project timelines, reviewing study plans, and ensuring the delivery of high-quality data.
• Ensure all internal and external bioanalytical activities adhere to relevant regulatory guidelines (e.g., ICH, FDA, EMA).
• Author, review, and approve key technical documents, including study protocols, SOPs, validation plans, and bioanalytical reports for regulatory submissions.
• Oversee the operation and maintenance of advanced analytical instrumentation (LC-MS/MS, UPLC) and provide expert-level troubleshooting for complex technical issues.
• Lead the team in the processing, interpretation, and presentation of complex bioanalytical data to drive project decisions and effectively communicate findings to senior management.
• Continuously evaluate and recommend new technologies and methodologies to improve bioanalytical capabilities, efficiency, and data quality.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, or a related field is highly preferred. MSc with extensive and relevant industry experience will be considered.
• 5+ years of experience in the pharmaceutical or biotechnology industry, with a focus on bioanalysis.
• A minimum of 2 years of direct leadership experience, including people management, mentoring, and team development.
• Broad knowledge of the characterization of diverse biological and synthetic materials (e.g., oligonucleotides, lipids, proteins, mAb, peptides) using a wide array of analytical and biophysical techniques.
• Extensive hands-on expertise with Liquid Chromatography (UPLC/HPLC) and Mass Spectrometry (LC-MS/MS), especially for the bioanalysis of molecules in complex biological matrices (e.g., for PK/PD studies).
• Deep theoretical knowledge and practical experience in the characterization of Lipid Nanoparticles (LNPs), liposomes, or similar drug delivery systems.
• Proven experience in developing and validating bioanalytical methods according to regulatory guidelines.
• Experience supporting drug development programs from discovery through IND-enabling studies, with a strong understanding of CMC and regulatory requirements.
• Demonstrated experience in managing and collaborating with external CROs.
• Exceptional multitasking, organizational, and project management skills.
• Excellent written and verbal communication skills in English.