Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job Description
Job Description:
We are seeking a highly motivated, results-oriented, self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility, to join a dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T-cell (CART) therapies.
The successful candidate will help to develop and qualify analytical methods for the characterization, release and stability testing of CART products. An emphasis is on acquiring additional staff with experience in multiparametric immunophenotyping using flow cytometry.
- Actively contribute to successful development, qualification and execution of robust, state-of-the-art analytical methods for characterization of CART manufacturing processes and products.
- Provide analytical support for clinical-scale non-GMP/ GMP IND-enabling manufacturing operations, including qualification of in-process and release methods and tech transfer internally and externally in support of GMP manufacturing and release of clinical material.
- Contribute to relevant and impactful innovation programs to enhance product characterization technologies.
- Contribute to project technical teams to ensure effective integration at all levels. Communicate and collaborate effectively.
- Demonstrate strong accountability as well as good organizational and interpersonal skills.
- Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports.
- Present data to scientists and management in internal venues (technical and project team meetings).
- Industry laboratory experience in a variety of analytical methods for the characterization and GMP release of cell-based or gene-therapies, especially cell-based and flow cytometry-related characterization/ release/ stability testing.
- Applied skills in molecular immunology/ T-cell biology and primary T cell culture/ expansion and characterization.
- Familiarity with cGMPs and relevant Regulatory Guidance documents.
- Laboratory work using qualified instrumentation, and technical analysis at provided work stations.
Competency
- T-cell flow cytometry
- T-cell biology
- Good laboratory practices (GLP)
- Responsible for general laboratory and operational support, including providing logistical support for samples and compounds management, ordering supplies and carrying out general bench work activities.
Qualifications
Qualification:
BSc/ MSc degree in Immunology/ Molecular Biology with 3+ years of experience in biotech/ bio pharma industry (preferably in the development of analytical methods for the characterization of gene- or cell-based therapies).