Scientist II/Scientific Technical Leader, Translational BioAnalytics
Editas Medicine, United States
Job Description
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases.
We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before.
Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
The Biological Development department at Editas Medicine is seeking a motivated individual to join the Translational Bioanalytical group to progress the clinical development in hemoglobinopathies, ocular and immuno-oncology therapeutic areas. The successful candidate will interact cross-functionally with the clinical, research and external contract research organizations to facilitate clinical assay development, transfer, validation and sample testing. The successful candidate should demonstrate strong work ethics, great communication skill and ability to work in a fast-paced and highly collaborative work environment.
Key Responsibilities
- Manage clinical assay transfer, validation and sample testing in CROs to advance clinical development in hemoglobinopathies, ocular and immune-oncology therapeutic areas
- Efficiently maintain timeline of milestones for studies, develop gantt charts, timelines to ensure proper overall execution of clinical assays
- Interact with external partners and follow the relevant regulatory agency guidelines to transfer assays in support of clinical trial development
- Review all site-facing assay related manuals, laboratory specification agreements, validation specifications, and processes for assay development that follow CLIS/GCP/GLP regulations
- Participate in cross-functional clinical trial meetings, identify key areas of risk to advance validation of clinical assays and operation of clinical trial samples at CROs
- Review validation plan, reports and data transfer plan for regulatory submissions, electronic data capture and data transfer to clinical sites
Requirements
- Bachelors or Masters Degree in Biology or relevant life science degree; with minimum 10 years of hands-on industry clinical trial experience in CRO management, assay operations and data transfer; PhD in Biology or relevant life science degree with 2-5 years of hands-on industry clinical trial experience in CRO management, assay operations and data transfer.
- Experience with CRO management in clinical assay transfer, clinical sample testing and data management.
- Experience in analytical assay validation of hematology, molecular, immunological assays, ELISA and cell-based assay is a plus
- Working experiences with biologics, human tissue samples, nucleic acid, gene and cell therapies is highly desirable
- Ability to think critically and work independently within a matrixed organization
- Proficiency with project management tools, analytics and visual reporting applications
- Excellent oral and written communication skills