Casebia Therapeutics

Job Title: Bioanalytical Scientist/Senior Scientist

Job Number: 21995

Location: Cambridge, MA

Job Description

Casebia Therapeutics is seeking a Scientist or Senior Scientist (depending on experience) to join the pharmacology/toxicology team to provide bioanalytical support across all therapeutic programs. In this role, you will develop and qualify bioanalytical methods to support preclinical and clinical development of novel gene editing therapies, including PCR, immunogenicity assays, cell-based assays, and immunoassays. The candidate will have a strong background in molecular and cell biology and will have the ability to carry out both lab and management responsibilities, ensuring scientific rigor and quality documentation. This is a unique opportunity to become a key member of a growing team, implementing bioanalytical assays across all programs to bring life-changing therapies to patients.

Responsibilities

  • Develop and implement bioanalytical methods, including PCR, immunogenicity assays, immunoassays, and cell-based assays
  • Evaluate and document performance of assays in method qualification or validation studies
  • Perform or manage bioanalytical sample analysis studies, review and report results
  • Manage implementation of assays in CROs, including technology transfer, qualification or validation, sample analysis, and data transfer
  • Develop and maintain clear and concise lab records and documentation
  • Author and review method SOPs, qualification protocols, and qualification reports
  • Contribute to relevant sections of regulatory filings and responses to questions

Required Skills

  • PhD in Molecular Biology, Cell Biology or related field with at least 3-5 years of assay development experience
  • Strong foundational knowledge in PCR, cell-based assays, and immunoassays with experience in handling biospecimens
  • Excellent hands-on technical skills and the ability to independently develop, implement, and execute bioanalytical assays
  • Ability to engage with team members to understand the requirements for the assays and intended use of results
  • Experience in relevant methodology, emerging new technologies, troubleshooting, and problem-solving
  • Demonstrated ability to investigate and develop new bioanalytical approaches and strategies either independently or through collaboration
  • Excellent organizational, record keeping, documentation, and written communication skills
  • Ability to collaborate effectively in a team-oriented environment
  • Willingness to travel approximately 5% of the time to present data at scientific meetings or engage with external CROs

Preferred Skills & Qualifications:

  • Experience in developing bioanalytical assays to support gene therapy products
  • Knowledge of bioanalytical assay development, qualification, and validation requirements to comply with applicable regulatory standards
  • Knowledge and experience with research informatics systems and tools such as LIMS or electronic documentation systems
  • Experience working in a GLP environment
  • Experience in CRO management and oversight for bioanalytical assay development, validation, and sample analysis
  • Previous experience mentoring associate scientists is preferred
  • Experience authoring sections of regulatory documents
  • Experience working with viral vectors for gene delivery or various gene editing techniques
  • Demonstration of process continuous improvement

 

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