Job Description
About the role
A leading biotechnology company developing next- gene and cell therapies is seeking a contract Scientist to join its Analytical Genomics team in Cambridge, MA. As a lab-based Scientist, you will work closely with the Director of Analytical Genomics to develop and optimize molecular and genomics assays in support of a Type 1 diabetes cell therapy program.
The ideal candidate will have a strong analytical background in molecular and genomics assays, with expertise in assay development, optimization, and qualification, as well as experience with GxP compliance and documentation. This role requires attention to detail, the ability to multitask in a collaborative environment, and an agile, team-first mindset.
What you’ll do
* Develop, optimize, and qualify molecular and genomics assays, including assay controls, QC metrics, and acceptance criteria, while implementing solutions for complex technical issues.
* Develop and execute biodistribution ddPCR assays for IND-enabling studies.
* Perform and optimize single-cell dissociation, scRNA-seq library preparation, QC, and sequencing using 10X Genomics technologies.
* Execute genome integrity assessment assays as needed to support research and IND-enabling studies.
* Maintain accurate, audit-ready records of metadata, procedures, and results in Benchling ELN and GxP documentation.
* Analyze, QC, and interpret experimental data; prepare presentations and reports for team meetings.
* Author and review SOPs, method qualification reports, and GxP documentation to support regulatory submissions.
* Manage lab supplies, sample/reagent inventory, CRO and cross-site shipments, and support lab instrument qualification, calibration, and maintenance to meet GxP requirements.
What we’re looking for
* PhD in cell/molecular biology, biochemistry, or related field with 0–2 years of industry experience, or MS with 7+ years (or equivalent combination of education and experience).
* 4+ years of hands-on laboratory experience with expertise in DNA/RNA extraction, quantification and QC, ddPCR/RT-ddPCR, qPCR, NGS library prep methods (including scRNA-seq), and operating Illumina sequencers.
* Experience with assay characterization and qualification of molecular/genomics analytical metrics for regulatory filings.
* Proficiency with Benchling, SOP writing, and GxP documentation.
* Strong organization, communication, and meticulous record-keeping skills; proven team player.
What will separate you from the crowd
* Experience with biodistribution studies of cell and gene therapy products.
* Experience executing genome integrity assays to support regulatory filings.
* Knowledge of GxP and regulatory expectations for analytical methods, assay qualification, lab compliance, and documentation.
* Hands-on experience with automated instruments (e.g., Hamilton, Kingfisher).
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