Scientist, Bioanalytical

Homology is seeking an innovative, energetic scientist to collaborate in the development of gene editing/gene therapy programs. The successful candidate will have a strong background in the development and implementation of bioanalytical assays to support the development of biologics (antibody, ELISA, qPCR, RT-PCR, ELIspot) for preclinical programs through clinical development. The selected candidate will apply their existing knowledge of assays and regulatory guidances to new assays and methods to support the development of novel AAV gene transfer and gene editing programs. This position reports to the Head of Toxicology.

Essential Functions and Duties

  • Plan, implement and manage activities and interactions to deliver key bioanalytical methods to support IND and clinical stage drug candidates, including antibody assays, qPCR and RT-PCR, ELIspot, biomarkers, mass spectrometry, enzyme activity and novel assay systems
  • Identify and select appropriate CRO’s through collaboration with Research, Clinical Operations and Quality
  • Work with Research colleagues to develop, refine and validate assays for pharmacodynamic markers related to the mechanism of action of the drug in nonclinical and clinical development
  • Lead development and validation for methods to support GLP nonclinical studies and clinical assays at CRO’s using a variety of modalities
  • Collaborate with CRO’s to support testing of samples to meet timelines for nonclinical studies, prove Clinical Operations with validated assays for sample analysis
  • Review and finalize validation reports to ensure scientific validity and regulatory requirements, and author IND sections and regulatory responses regarding bioanalytical methods and sample analysis
  • Work with Clinical Operations to transition validated biomarker and patient selection assays for implementation in the clinical trial by Clinical Operations and the CRO(s)
  • Commit to help the team provide deliverables and meet aggressive timelines

Skills and Experience

  • BS/MS and 6+ years or PhD + 3 years in pharmaceutical, biotech industry, or contract research organization experience with demonstrated experience in bioanalysis (outsourcing or conduct of assays)
  • Direct experience in assay method development, qualification and validation
  • Knowledge of Good Laboratory Practices
  • Experience in assay method conduct and/or transfer to GLP testing facilities
  • Familiar with relevant bioanalytical guidances and white papers
  • Experienced with ligand binding assays (ELISA) or PCR, and familiar with methods such as enzyme activity, PCR, ELIspot, and mass spectrometry-based assays
  • In depth knowledge with bioanalytical assay methods, sample requirements, and pre-analytical factors affecting sample quality
  • Experience of successfully working in cross-functional teams, as well as with external CROs to ensure excellent communication and timely delivery of data
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail
  • Ability to identify / follow cutting edge research to develop innovative approaches
  • Self-motivated, independent, and innovative

Interested candidates should forward a cover letter and resume / CV to careers@homologymedicines.com