Join Our Crew

Responsibilities Include

• Lead the design, development, optimization, and qualification of analytical methods or other advanced technologies, as required to evaluate safety, purity, identity, potency of lentiviral vectors and cell therapy products.
• Provide technical expertise and guidance on analytical techniques, instrumentation, and data analysis methodologies.
• Analyze and interpret experimental data, troubleshoot technical challenges, and propose solutions to drive continuous improvement in analytical methods.
• Execute quality control assays to analyze lentiviral vectors, and cell products manufactured by external partners.
• Develop new analytical tests to assess advanced gene transfer and gene editing modalities.
• Assist to author analytical development report, assay qualification report and other technical documents for technical correctness and regulatory compliance.
• Participate in technical troubleshooting and problem investigation.
• Prepare, evaluate, and present data internally to cross functional teams.
• Generate and communicate research findings through presentations, scientific publications, and contributions to regulatory documents.
• Provide technical guidance, mentorship, and training to junior scientists and research associates within the team.

Required Qualifications

• MS with a minimum of 3-5 years’industry experience or PhD degree with a minimum of 2-4 years of industry experience in a relevant scientific discipline (e.g., cell biology, immunology, biochemistry, biotechnology) in analytical development for cell therapy or biologics.
• Proven expertise in developing and qualifying analytical assays for the characterization of cell-based products, including flow cytometry, ELISA/MSD, qPCR/dPCR/ddPCR, cell-based assays, potency assays and other advanced technologies.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH guidelines) governing analytical method qualification/validation, data integrity, and GMP compliance in the biopharmaceutical industry.
• Excellent analytical and problem-solving skills, with the ability to analyze complex data sets, identify trends, and propose data-driven solutions.
• Effective communication and interpersonal skills, with the ability to collaborate effectively in a multidisciplinary team environment and present technical information clearly and concisely.
• Proven track record of successful project management, including the ability to prioritize tasks, manage timelines, and deliver high-quality results in a fast-paced, dynamic environment.
• Strong leadership qualities with a passion for mentoring and developing junior team members. Strong team orientation and passion for continuous self-development.
• Experience in the biotech industry or in a startup industrial setting is preferred.

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