About us

Coave Therapeutics is a preclinical-stage biotechnology company committed to developing groundbreaking gene therapies. Powered by its proprietary ALIGATER™ Advanced Vectors-Ligand Conjugates) platform, Coave develops a novel class of AAV and LNP gene delivery systems with superior targeting, specificity, efficacy across a wide range of applications. Importantly, the platform streamlines manufacturing by eliminating the need for prior AAV capsid modifications. By overcoming critical challenges in delivering genetic payloads to extra-hepatic tissues, Coave is building a pipeline of innovative gene therapies aimed at transforming the treatment of rare and common diseases, with a particular focus on muscle, neuromuscular, and eye diseases.

Director of Analytical development

The Director of Analytical Development is expected to provide key technical leadership in advancing our biophysical and biochemical analytical development capacities. Extensive experience in analytical development for biologics ideally Antibody Drug Conjugates and/or gene therapy is desired. Strong technical expertise in bio-separation science, Mass Spec characterizations, biophysical and biochemical analysis is desired. In addition to leading the investigation and development of characterization assays supporting the Aligater platform, and quality controls for our pipeline of AAV conjugates-based gene therapies, the role includes oversight of external method qualifications and validations and support of QC testing of clinical trial material. This individual will work closely with the discovery and the Process Development teams as well as with Manufacturing and external partners.

The position is based in Lyon.

Responsibilities

• Lead the analytical strategy and deployment of analytical toolbox for characterization and quality control of conjugated AAVs

• Provide science-based recommendations to lead the advancement of the knowledge of our conjugates; serving as a subject matter expert (SME)
• Establish and execute strategies for assay development, optimization, and when applicable transfer, qualification, and validation and be proactive in testing and implementing new technology
• Collaborate with research and process development to leverage and develop and implement fit-for-purpose analytics
• Oversee and lead technical specialists in the evaluation and implementation of analytical procedures relevant to product characterization
• Accountable for the accuracy of technical reports, protocols, and regulatory filings
• Collaborate closely across multiple functions and with external partners and ensure method validations are aligned with current ICH and regulatory guidelines
• Through Analytical Sciences and Technology, support the transfer and phase-appropriate validation of assays to CRO and CDMO partners and, when needed, provide guidance to support their successful execution

Profile

• Master’s degree or PhD in Analytical or Bioanalytical chemistry, or related field with at least 5 years of experience directly applicable to the job responsibilities
• Biotech and/or pharmaceutical industry experience, including the transition of early-stage QC methods to late-stage programs, including preparation of regulatory filings
• Strong experience and expertise with complex bioconjugated product is required (ideally in the gene therapy and/or ADC field)
• Experience in CMC analytical development of biologics (ideally gene therapies and/or ADC).
• Deep understanding of bioconjugation interfacing chemistry and biology to characterize and qualify conjugated vectors
• A demonstrated track record of successfully transferring, qualifying, and validating analytical methods. Familiarity with GMP, ICH, and associated regulatory guidelines
• In-depth knowledge and extensive hands-on experience with analytical chemistry and molecular biology methods, including SEC, CE, UPLC/HPLC, Mass Spectrometry, ELISA, Western blot, ddPCR, RT-PCR, SPR/BLI, and flow cytometry/FACS and ability to troubleshoot
• Ability to effectively lead complex projects with a cross-functional internal/external team.
• Must be organized, self-motivated and capable of working independently and in a collaborative multi-disciplinary environment.
• Excellent problem-solving skills