Workforce Genetics is currently recruiting for a Senior Scientist, Bioanalysis to join an innovative cell therapy company in Gaithersburg, MD.

About the company: Our client is a clinical-stage biotech company focused on the development of novel cell therapies for cancer and autoimmune diseases.

Overview: The Senior Scientist position is open to highly motivated and innovative candidates with a Ph.D. degree 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 clinical drug candidates. His/her function will include developing and implementing PK and immunogenicity assays to support pre-clinical and clinical studies.

Responsibilities: 

• 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.

Preferred Qualifications:

• 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 platforms such as ELISA and MSD per industry and regulatory guidelines
• Strong troubleshooting 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 is a plus.
• Experience working in a regulated environment and knowledge of GxP are required.