The Assay Lead is a key member of Research Vector Core. The successful candidate will play a leading role in the research grade rAAV vector characterization and release. He/she will Lead an assay/DNA team and manage direct reports on their performance and daily activities. He/she will be responsible for:
- Oversee and manage the assay/DNA team workloads; work alongside with assay team on day-to -day vector release assay and plasmid production and release
- Plan, coordinate and execute the research grade rAAV vector releases
- Plan, coordinate and execute plasmid preparation and release for vector productions
- Author/review assay records, protocols; Generate CoAs for vector releases; Analyze and interpret results; Summarize data in an appropriate format as needed
- Optimize and develop analytical methods; Support process optimization and production trouble shooting
- Address complex assay issues and resolve the issues timely by demonstrating and applying cross-functional knowledge, perform supporting studies as needed
- Represent department as a primary contact on vector characterization related challenges
- Interface with Therapeutic areas, Next-Gen Sequencing and data science for viral vector characterization
- Supervise and provide guidance to the assay/DNA team
This position requires:
- Advanced knowledge of bioanalytical science and strong background in molecular biology
- In-depth experience in conducting assays for rAAV products including testing for quantification, purity, identity, and safety; capability for troubleshooting assay and/or equipment issues
- Advanced ability to critically analyze problems, develop potential solutions and evaluate impact to the organization
- Supervisory experience and the ability to work/communicate effectively with fellow team members and with project teams
- Plan for rAAV vector releases in a timely manner
- Mange work load within assay team
- Prioritize release assay schedules as needed
- Work alongside the team in the hands-on assays of rAAV vectors
- Design experiments, organize, discuss and record experimental data
Education and Experience Requirements
- Address complex assay issues
- Author/review assay records
- Generate CoA for vector releases
- Manage performance and develop people
- Lead assay team in a manner that is consistent with Spark culture
Key Skills, Abilities, and Competencies
- Typically has a Ph.D in a scientific discipline (e.g. molecular biology, biochemistry, genetics) with 5+ years of related experience; May also have a M.S degree with 10+ years biotechnology or pharmaceutical industry experience.
- Hands on experience in performing analytical methods for rAAV including quantification (qPCR and dPCR), purity, identity, and safety
- Experience in industry under regulated environment is preferred
- Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
- Strict attention to details. Excellent organizational and multi-tasking skills are required
- Excellent personal communication skills
- Previous supervisory experience is preferred
- Strong organizational skills.
- Excellent writing and verbal communication skills.
- Independently motivated, detail oriented and excellent problem solving ability.
- Highly adaptable and comfortable in an environment with dynamic priority demands
- Ability to multitask.
- Ability to analyze and troubleshoot experiments.
- Ability to work independently and as part of a team after initial training
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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