Analytical Scientist I
2 weeks ago
Company Overview: Integrated Resources, Inc. is a leading organization with a wealth of experience in the industry. Our mission is to provide strategic workforce solutions that enhance talent management and operational efficiency. Since our inception in 1996, we have successfully attracted and retained top-tier professionals who are experts in their respective fields, enabling us to expand into diverse sectors.
Position OverviewRole Summary:
We are in search of a dedicated and results-driven individual who exhibits a strong sense of accountability and is eager to take on increasing responsibilities. This role is pivotal in a dynamic team focused on the effective development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T-cell (CART) therapies.
The ideal candidate will play a crucial role in the development and qualification of analytical methodologies for the characterization, release, and stability assessment of CART products. A key focus will be on recruiting individuals with expertise in multiparametric immunophenotyping utilizing flow cytometry.
- Actively engage in the successful development, qualification, and implementation of advanced analytical techniques for the characterization of CART manufacturing processes and products.
- Provide analytical assistance for clinical-scale non-GMP/GMP IND-enabling manufacturing operations, including the qualification of in-process and release methodologies, as well as technology transfer both internally and externally to support GMP manufacturing and release of clinical materials.
- Contribute to innovative programs that enhance product characterization technologies.
- Collaborate with project technical teams to ensure effective integration at all levels, fostering clear communication and teamwork.
- Exhibit strong accountability along with excellent organizational and interpersonal skills.
- Ensure timely and high-quality documentation in electronic laboratory notebooks and technical reports.
- Present findings to scientists and management in internal forums, including technical and project team meetings.
- Possess industry laboratory experience in various analytical techniques for the characterization and GMP release of cell-based or gene therapies, particularly those related to flow cytometry.
- Demonstrate applied knowledge in molecular immunology, T-cell biology, and primary T-cell culture, expansion, and characterization.
- Have familiarity with cGMP regulations and relevant regulatory guidance documents.
- Conduct laboratory work utilizing qualified instrumentation and perform technical analyses at designated workstations.
Core Competencies:
- T-cell flow cytometry expertise
- In-depth understanding of T-cell biology
- Adherence to good laboratory practices (GLP)
- Responsible for general laboratory and operational support, including logistical management of samples and compounds, ordering supplies, and executing general bench work activities.
Educational Background:
BSc/MSc degree in Immunology or Molecular Biology with a minimum of 3 years of experience in the biotech or biopharma sector, preferably in the development of analytical methods for characterizing gene- or cell-based therapies.
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