Senior Scientist, Oligonucleotide Process Development

Location
Cambridge, MA, United States
Posted
Sep 05, 2020
Ref
2088468132
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 is seeking a highly skilled and motivated Senior Scientist to join our new and growing synthetic nucleic acid process development team within Technical Operations (CMC). The primary responsibilities for this position are to develop, establish and evaluate processes for solid-phase synthesis and purification of modified and difficult oligonucleotide sequences for the CRISPR/Cas9 system related to both, ex vivo and in vivo applications. In partnership with Intellia's cross-functional platform development team, and in support of Intellia's programs the successful candidate will be developing processes for manufacturing of novel oligonucleotide modalities and support the tech transfer to external manufacturing organizations. The successful candidate will have a proven track record in oligonucleotide synthesis and purification in a pharmaceutical research and development setting.

Responsibilities:
    • Plan and assist in setup of Intellia's new oligonucleotide process development laboratory and establish supply chains as well as evaluate and test technologies in conjunction with internal SMEs and external vendors.
    • Independently plan, design and execute solid phase oligonucleotide syntheses and employ process monitoring techniques to evaluate the effectiveness of the synthesis
    • Identify critical process parameters and ways to improve the quality of the final product while considering the constraints of downstream GMP manufacturing
    • Develop modules for standard process evaluation of novel oligonucleotide sequences and bring new ideas to innovate oligonucleotide synthesis applicable to GMP manufacture
    • Adopt conditions from external manufacturers and internal research for feasibility assessments. Work cross-functionally with representatives of chemistry and analytical development
    • Develop and optimize scalable oligonucleotide purification methods under tight timelines
    • Act as SME and technical resource within the technical operations team and support regulatory filings
    • Author technical documentation such as SOPs, method documents, training documents, batch records and reports. Generate presentation materials and present data and findings to the larger group, cross functional teams and external partners
    • Access the literature, regulatory/guidance, databases, and technical documents to develop strategy, work plans, and timelines for discussion with supervisors and SMEs.
    • Review data, documents, batch records, analytical methods/qualifications, data from external vendors and support technology transfer activities involving CROs/CMOs.


Minimum Qualifications:
    • PhD in Chemistry, Biochemistry, Biotechnology or related field with 3 or more years of experience working in a regulated pharmaceutical industry setting
    • Extensive hands-on experience with solid phase oligonucleotide synthesis and competence in operation of lab-scale oligonucleotide synthesizers including knowledge of respective monitoring and software concepts
    • Experience with chromatographic purification methods (HPLC)
    • Experiences in standard laboratory techniques and analytical instrumentation (spectroscopic methods)
    • Knowledge of the principles of quality and GMP practices for manufacturing and testing
    • High competence in common software and data analysis packages (e.g., Unicorn, SoftMax Pro, GraphPad Prism, Microsoft Office tools)
    • Creativity, problem-solving ability, and an operational vision for development workflows
    • Highly organized individual, detail-oriented, and a self-starter who continuously seeks to improve the status quo.
    • Effective verbal and written communication skills are required


Preferred Qualifications:
    • Experience with RNA synthesis for the CRISPR/Cas9 system is preferred
    • Experience with chromatographic purification of oligonucleotides (MPLC and HPLC) as well as general analytical techniques used for the analysis of DNA/RNA oligonucleotides. Experience with HR-MS/MS techniques is a plus


#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.

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