Kelly Science is seeking a Bioanalytical Scientist to join a growing team located in Cambridge, MA.
Employment Type: Contract with the possibility of being hire on permanently
Summary:
As the Bioanalytical Scientist, you will be responsible for providing bioanalytical method development and PK and ADA sample analysis to assist in developing novel therapies to treat targeted patient populations within multiple oncology indications.
Job duties include:
- Independently design, develop, and qualify MSD based assays/methodologies to analyze serum samples for drug and anti-drug antibodies resulting from PK/PD, PK, and toxicology studies and develop complex strategies and enable the advancement of company objectives.
- Perform quantitative bioanalytical immunoassay experiments to support non-regulated pharmacokinetic (PK) analyses of biotherapeutic drug candidates and evaluate anti-drug antibody (ADA) responses.
- Facilitate assay transfer activities in collaboration with external CROs for assay validation in compliance with regulatory standards.
- Support development of regulated and clinical bioanalytical strategies for large molecule drug candidates, and conduct PK, ADA, and biomarker assays internally.
- Contribute to outsourcing of non-GLP, GLP, and GCLP clinical BA assays.
- Review and edit GLP and clinical BA assay validation protocols, and reports.
- Review and evaluate immunoassay bioanalytical results supplied by external CROs to ensure quality; review GLP and clinical BA assay validation protocols and reports.
- Prepare bioanalytical method summaries to support preparation of study reports and relevant sections of regulatory IND/CTA filings.
Qualifications include:
- Bachelors degree in biochemistry, analytical chemistry, pharmacokinetics or a related scientific field required. Masters or PhD in biochemistry, analytical chemistry, pharmacokinetics or a related scientific field preferred.
- 4+ years of experience with method development, and immunoassay/ligand binding assay techniques for biotherapeutic quantification in complex biological matrices.
- Experience utilizing MSD technology is strongly preferred, or extensive experience with ELISA-based methodologies.