Job Description
Accelevir Diagnostics is a growing Maryland biotechnology company creating innovative assays for ultra-rare analytes in infectious disease and beyond. With expertise spanning virology, immunology, and genomics, our team develops, scales, and commercializes complex assay workflows to support our biopharma partners from basic research through clinical trials. To drive the growth of our assay services team, we are looking for a Team Lead in Genomic Services desiring to work in an intellectually challenging and fast paced start-up environment.
About the Role:
In this leadership role, you will work with management to oversee the operation and expansion of our genomic assay services business unit for biopharma clients. This role offers a unique opportunity for creativity, growth, and high impact in expanding a successful assay services program.
In this position, you will provide technical and scientific oversight to the Genomic Services team and drive the validation and execution of innovative molecular biology and genomics assay services for biopharma and large academic clients. You will ensure operational excellence and data quality across an existing test menu focused on molecular virology. In addition, you will be critical in guiding the expansion of our genomic assay services offerings to drive revenue growth.
Specific expertise in the following areas is desired:
- Development and validation of molecular/genomics assays for use as primary or surrogate clinical trial endpoints, for clinical trial stratification, or for MRD monitoring.
- Current NGS approaches in epigenetics, transcriptomics, and immunogenomics
- Development of highly multiplexed digital PCR and RT-dPCR assays
- Emerging genomics approaches, including spatial transcriptomics and single cell analysis
Your success in this role will require expertise in complex molecular and genomic assay optimization, validation, and execution while working under a quality management system in a regulated testing environment. To ensure that success, you will be strongly supported through direct interactions with biopharma clients and academic experts. The ideal candidate is a highly motivated and proactive scientist with strong communication skills who will enable the team to understand and address customer requirements in order to deliver a high-quality work product.
Responsibilities:
- Establish, optimize, validate, and deploy new genomics assay service offerings
- Coordinate and supervise day-to-day laboratory activities within the Genomics Services team
- Review primary testing data and documentation for quality, completeness, and adherence to established policies and procedures
- Understand guidance documents and define Fit for Purpose assay qualification standards
- Liaise with external customers to coordinate establishment of project work orders, transfer of project samples/materials, and communication of project results
- Develop project plans with timelines, deliverables, and budgets
- Achieve expansion targets and financial goals for the Genomic Services team
Education and Experience Requirements:
- Ph.D. with expertise in complex molecular and genomics assays and relevant work experience in a biomarker or assay development group within a CRO, CMO, and/or Core facility; OR
- Master’s degree in Genomics or related field with minimum of six (6) years of professional experience in a regulated environment focused on the development and validation of complex molecular and genomics assays
- Demonstrated experience in building the assay portfolio of a business unit and managing customer-facing programs
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