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Description:
ABOUT THE POSITION
Reporting to Director, Analytical Development, We are seeking a talented and experienced Associate Principal Scientist/Senior Scientist with expertise in development and qualification of phase-appropriate analytical test methods for cell therapy products. The successful candidate will contribute to the development of advanced analytics to characterize quality attributes of CAART and CARTA cell therapies which leads to better treatment efficacy and safety. The individual will also play a crucial role in advancing our analytical capabilities to support the development of novel CAR- and CAAR-T cell therapy products, lentiviral vector, new gene transfer/gene editing methodologies and potential clinical programs.
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.
Apply For This Job
Responsibilities:
- 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.
