Senior Scientist- Bioanalytical Assay Development, eDEV & TM

Location
Cambridge, MA, United States
Posted
Nov 04, 2020
Ref
814156767
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

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.

GENERAL RESPONSIBILITIES:
    • 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.


REQUIRED SKILLS:
    • 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.


PREFERRED SKILLS:
    • 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


QUALIFICATIONS:
    • 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.


#LI-DG1

What Intellia Stands For:

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds...free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

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.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .