Intellia is seeking a highly skilled and motivated bioanalytical assay development Senior Scientist to join our growing team in Early Development & Translational Medicine. The primary responsibilities for this position will be to develop novel bioanalytical methods and perform sample analysis as well as oversee CRO functions for quantification of sgRNA, Cas9 mRNA, AAV vector genes and transgenes in biological matrices to advance CRISPR/Cas9 in vivo and ex vivo gene editing therapeutic in non-clinical and clinical stages of development.
Select appropriate assay platform that serves intended use and design novel methods.
Develop and optimize qPCR, qRT-PCR, ddPCR, and/or b-DNA, for quantification of DNA and RNA (as part of therapeutics such as LNP and gene therapy) in biological sample matrices to advance CRISPR/Cas9 therapeutic development.
Test samples at Intellia laboratory using the above methods. Write internal bioanalysis reports.
Qualify assays and transfer them to CROs for validation and sample analysis in a GLP/GCLP environment.
Oversee CRO method development, validation, and sample analysis in rodent, non-human primates, and human in a compliance regulatory laboratory environment. Collaborate with internal teams on CRO scope of work, contracts, and invoice payments.
Manage CRO timelines and deliverables for quality data, validation reports, and sample analysis reports.
Conduct assay failure investigations for both internal and CRO sample analysis functions.
Analyze data (independently and in collaboration with teams) for PK, PD, and distribution studies and contribute to data driven decisions and strategies to understand drug efficacy, safety, and mechanism of action. Communicate to internal teams on timelines and results.
Contribute to regulatory documents (such as CTA and IND) to advance drug development.
Serve as scientific and technical expert in the area of molecular biology and functional genomics.
Manage junior staff for above functions.
Ph.D in chemistry, biochemistry, biology, or other life-science area, with > 3 years of experience including industry experience.
Post-doc in relevant field and industry experience.
Exceptional non-PhD with bachelors or masters degree in the relevant field is acceptable.
Familiarity with regulatory (such as FDA, EMA, ICH, and other guidelines) on quantification of therapeutics in biological matrices.
Experienced in selection of suitable oligonucleotide primers and probes as part of PCR methods for the quantitation of nucleic acid, RNA and DNA, by PCR based methods using Taqman or ddPCR.
In-depth scientific knowledge and hands on skills to apply broad physicochemical and biological properties of target analyte (DNA or RNA, proteins, and small molecules) to select appropriate assay platforms and understand assay performance characteristics. Assays include, but not limited to PCR based methods.
Experience with technologies such as Droplet Digital PCR (ddPCR), qPCR and qRT-PCR, HPLCs, and Hamilton Starlet (or equivalent).
Hands on knowledge on tissue extractions (~ 20 tissue types) for quantification of drug components.
Independently develop bioanalytical assays for sgRNA across programs, these included optimization of many parameters such as selection of appropriate amplicon from template, optimize primer design as well as probe and quencher.
Optimize assay conditions at every step to make sure the methods can be successfully validated to meet regulatory expectations and GLP/GCLP requirement. These works included rodent, monkey, and human assays in plasma and large set of tissues as part of distribution studies.
Transfer assays to CROs and oversee assay development, validation, and sample analysis for all programs in different disease areas for both in vivo and ex vivo CRISPR/Cas9 gene editing therapeutics, cell and gene therapies.
Serve as functional genomics expert and work with research groups to understand CRISPR/Cas9 gene editing mechanism of actions.
Familiarity on Octet (or Biacore), different HPLCs, Microscopy, Li-COR Odyssey, Hamilton automated system, MSD, capillary gel-electrophoresis, and cell-based analysis.
Has supported therapeutic development in CAR-T and/or gene therapies in clinical stages
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.