Senior Scientist, Bioanalysis
The Senior Scientist position is open to highly motivated and innovative candidates with a Ph.D. degree, a successful post-doctoral fellowship and 7+ years of experience working in the biotechnology or pharmaceutical industry setting. The incumbent will be part of the Biomarker and Bioanalysis Group within Translational Sciences responsible for biomarker and bioanalytical strategies across Arcellx clinical drug candidates. His/her function will include developing and implementing PK and immunogenicity assays to support pre-clinical and clinical studies.
ABOUT ARCELLX: Arcellx (https://arcellx.com/) 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 main responsibilities will include but are not limited to:
- Develop ligand binding assays (ELISA, MSD) for PK and immunogenicity assessment to support pre-clinical and clinical studies. Responsible for data analysis and interpretation.
- Manage PK and immunogenicity assay development, transfer, and validation at CROs.
- Maintain current knowledge of industry best practices and requirements for ligand binding and immunogenicity assays.
- Contribute to developing bioanalytical strategies and methods to support biomarker, pharmacokinetics and pharmacodynamics, and immunogenicity assessments of clinical drug candidates.
- Responsible for review and approval of internal and external bioanalytical data and reports to ensure quality and integrity.
- Develops and implements Standard Operating Procedures (SOPs).
- Contribute to regulatory document preparation including IND, clinical protocol, integrated summary of immunogenicity, regulatory responses, and submissions.
- Collaborate with discovery, preclinical development, regulatory and clinical teams to accelerate product pipelines.
- May supervise research associates.
- PhD in Cell Biology, Immunology, Pharmacology, or related disciplines.
- Seven (7+) years of PK and immunogenicity assessment experience in the pharmaceutical industry or CRO.
- Hands-on experience with assay development for large molecules in support of preclinical and clinical PK/ADA/NAb assays.
- Strong experience with PK and immunogenicity assays validation with common platform such as ELISA and MSD per industry and regulatory guidelines
- Strong trouble shooting skills and in-depth knowledge of assessing assay performance.
- Experience with immunogenicity assessment strategies, integrated summary of immunogenicity and document preparation for regulatory submissions.
- Proficiency in common software and data analysis packages e.g., GraphPad Prism. Experience with Phoenix WinNonlin software a plus.
- Experience working in a regulated environment and knowledge of GxP are required.
- 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.
- Strong written and oral communication skills necessary to report on and deliver scientific presentations.
- 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.
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.