Principal Scientist, Chromatography and Biophysical Characterization

Location
Cambridge, MA, United States
Posted
Sep 19, 2020
Ref
514250984
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.

Summary:

Intellia Therapeutics is seeking a motivated Principal Scientist/Group Leader to lead a group of junior level scientists and function as a senior member of the analytical development department. The primary responsibilities for this position will focus on the design, development and execution of advanced nucleic acid based analytical chromatography and biophysical characterization methods to quantitate and characterize a variety of molecular targets relevant to manufacturing and testing of gene therapy and cell therapy platforms. The successful candidate will lead and participate in cross-functional teams across Intellia to advance our understanding of the science of gene and cell therapy manufacture and performance.

Responsibilities:
    • Functions independently as technical expert in chromatography and biophysical characterization method development, execution and troubleshooting including but not limited to (HPLC, RP-HPLC, IEX-HPLC, ce-SDS, cIEF (R, NR) AUC, DLS as it related to RNA, lipid and viral products
    • Builds scientific knowledge capabilities, and strategies for method development through phased development in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization
    • Defines science-driven, phase appropriate, and risk-based analytical development strategies to support the development candidate during advancing clinical development stages
    • Plans and reviews own weekly/monthly activities for team with input in accordance with group/lab objectives and priorities
    • Acts as a technical resource in investigations, health authority inquiries and regulatory filings
    • Performs routine analytical testing in support of in house process development and product characterization activities
    • Represents the Analytical Development function on matrixed CMC and other development teams
    • Support the development of new methods by identifying, evaluatingandexecutinganalyticalmethodstosupportongoinganalyticalneeds
    • Participates in the support of analytical activities at CMOs and CROs related to analytics including method qualification and validation,data trending, troubleshooting, optimization, review and reporting
    • Assists in the execution of analytical development activities at CROs and CMOs, including deliverables and timelines; participate in tech transfer of intellectual property, protocols/procedures and know-how from internal labs to QC and CMOs/CROs,or between CMOs/CROs
    • Assesses method performance, identifies issues and proposes and implements appropriate remediation in conjunction with QA and company policies.
    • Participates in BLA-enabling activities including product and process characterization, comparability studies, CQA assessment activities
    • Authors and/or critically reviews key documents such as: comparability protocols,methods and reports
    • Assists in review and writing of regulatory filings including IND/IMPD and BLA
    • Collaborates with process development, QA and QC functions to ensure strong cross functional collaborationsandintegratedprocessandproductdevelopmentandcharacterization


Qualifications:
    • Ph.D in chemistry,biology, biochemistry or related field and 6+ years of experience or Masters' degree and 10+ years' experience in analytical development within a biotech/pharmaceutical analytical development and/or Quality Control environment required
    • Must have experience with biological products; Gene and cell therapy experience preferred; LNP and mRNA experience preferred
    • Knowledge of GMP as relevant to laboratory practices in sample handling and analysis of GLP and GMP samples
    • Knowledge of industry USP/ICH guidances for the development, qualification/ validation of analytical methods
    • High competence in common software and data analysis packages (e.g., Empower software, JMP, Microsoft Office tools)
    • Excellent organizational, documentation, and communication skills; adaptive learning, critical thinking, and the ability to work well in a team


#LI-KO1

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 .