Scientist/Scientist II – Biomarker and Bioanalysis
Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
The Scientist / Scientist II position is open to highly motivated and innovative candidates with a Ph.D. degree, a successful post-doctoral fellowship and relevant experience working in the biotechnology or pharmaceutical industry setting. The incumbent will be part of the Biomarker and Bioanalysis group within Translational Sciences which is responsible for establishing strategies and methods to assess Arcellx's drug candidates as they transition from preclinical to clinical development. The successful candidate will be responsible for development and validation of immunological based assays designed to characterize CAR-T and tumor cells from preclinical and clinical studies.
The main responsibilities will include but are not limited to:
- Design and perform relevant biomarker and immunological assays including multiparameter flow cytometry and cytokine analysis to support clinical trials
- Contribute to addressing key translational research questions in pre-clinical and clinical safety and efficacy studies such as understanding mechanism of action (MOA) of drug candidates
- Contribute to biomarker plan/strategies for clinical trials and execution of planned assays
- Develop in-vitro and ex-vivo assays to translate pre-clinical data into clinical biomarkers for advancing drug candidates through clinical trials
- Collaborate with discovery, preclinical development, process development, regulatory and clinical teams to accelerate product pipelines.
- Work with external partners and CROs in implementing developed and qualified assays
- Contribute to IND applications, clinical protocols and other regulatory documents
- Responsible for planning, designing, executing, recording and analyzing experiments
- Write and review SOPs, technical protocols and reports.
- May supervise research associates
- PhD in Immunology or related field with a background in human immunology, cellular therapy, immuno-oncology and/or tumor biology in hematological and solid malignancies. Experience and knowledge of CAR T therapies is preferred.
- Demonstrated experience working with clinical samples, assay development and validation of analytical methods per ICH Q2 guidelines
- Experience with development and implementation of relevant biomarker, bioanalysis, and immunological assays. Significant experience in multi-parameter flow cytometry a must. Proficient in multi-parameter flow cytometry (>12 colors)
- Experience working in a GCLP regulated environment
- Commitment to ethical scientific investigations and rigorous experimental methods.
- Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
- Demonstrated experience working on a multi-disciplinary team and ability to integrate cross-functional information
- Excellent organizational, communication skills, and attention to details
- Demonstrated ability to think critically and analyze and interpret data independently.
- Sense of urgency in performance of duties.
- Interpersonal skills that promote a collaborative and productive lab environment.
- Effective and efficient written and oral communication skills.
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.