Senior Scientist, Bioassay (Analytical Development)

Location
Cambridge, MA
Posted
Oct 08, 2021
Ref
R275
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Why Join Intellia? 

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. 

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. 

We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.   

How you will Achieve More with Intellia:

We are excited to welcome this new member to our growing team and company. This is both a strategic and lab-based role. If you are a strong problem-solver, have strong assay development experience, and enjoy cross-functional partnerships, this is the role for you! As the Senior Scientist, Bioassay, you will work on various projects including:

  • Developing, optimizing, and qualifying molecular-based, immunoassay, and characterization assays with established assay acceptance criteria for gene & cell therapy product characterization, lot release, and stability testing

  • Supporting as SME in tech transfer of analytical methods, protocols/procedures, and know-how from internal labs to external labs 

  • Performing routine and non-routine analytical testing, coordinating with internal/external PD or cGMP manufacturing on sample testing, compiling and presenting data to support process development and developmental stability studies

  • Evaluating novel assay technologies and methodologies that could improve existing analytical methods

  • Authoring and review SOPs, development reports, and assist in the preparation of CMC regulatory submissions

  • Assisting in maintaining/qualification of critical reagent supply for assigned methods

  • Working collaboratively with Analytical Development, Process Development, and Quality teams to gather and analyze data to achieve method readiness

  • Working closely with, and support quality control on investigations, OOS, OOTs and release assay troubleshooting

  • Maintaining well-documented records of analytical data, laboratory notebooks, execution of assays & stability data

About You:

Our ideal candidate has a degree in Biochemistry, Cell & Molecular biology, Genetics, or related disciplines with experience working within Analytical Development. This candidate will have the scientific knowledge to mentor junior scientists to develop methods required for late-stage products. If you describe yourself as a team player who loves method development, this role is for you!  Other desired skills include:

  • Experience in biotech or pharma industry with a primary focus on biologics and/or gene and cell therapy

  • Managerial experience desirable

  • Critical thinking, troubleshooting, and attention to detail are a must. You will be required to plan & execute experiments as well as analyze data generated at other sites for method improvements

  • AAV and/or Cell Therapy experience is highly desired

  • In-depth knowledge of molecular assays such as qPCR, ddPCR, and/or ELISA and enzymatic assays experience is required

  • Knowledge of FDA, cGMP, and ICH regulatory requirements in the context of bioassay/potency assay development and qualification is desired

  • Experience and knowledge of QC and GMP regulations is essential

  • Must be able to generate SOPs and technical reports with an appropriate level of detail, as well as perform bioassay trending

  • Experience working with CROs

  • A good understanding of statistical methods/tools for data analysis is a strong plus

  • Team player with good interpersonal and organizational skills

Meet your future team:

Analytical Development is a collaborative group supporting Process Development, Manufacturing, and Quality. You will report to the Principal Scientist, Analytical Development. This role will be responsible for assays supporting all modalities within analytical development and you will be responsible for building out the Testing Group in support of our overall efforts.

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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.