Associate Director, Potency Analytical Development
Company: Intellia Therapeutics
Location: Somerville
Posted on: January 12, 2021
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Job Description:
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.Job Description:Intellia is seeking a motivated
Associate Director or Principal Scientist to lead the Potency
function in our quickly growing Analytical Development team within
the Tech Ops organization. The primary responsibilities for this
position will focus on leading a group of scientists in the
development, troubleshooting, and qualification/validation of
cell-based bioassays and immunoassays, as well as the development
of internal analytical capabilities to support in house process
development. This person will be key in building a strategy across
the cell and gene therapy platforms for early and late stage
potency assay development and have had previous regulatory
experience both in filings and agency interactions.
Responsibilities:Lead, develop and mentor a group of scientists to
effectively design, develop, optimize, transfer, qualify and/or
validate novel cell-based bioassays and immunoassays for
potencyDraft and review SOPs, technical reports, and regulatory
documentsRepresent the Analytical Development function on matrixed
CMC and other development teamsLead the transfer of analytical
methods internally or to contract laboratories; manage internal
experiments and trend internal method performance and
specificationsLead bioassay comparability testing to support
process changes and transfers.Data review, approval, analysis,
graphing, reporting and presentation to internal and external
audiences, including regulatory agenciesAct as a technical resource
in investigations, health authority inquiries and regulatory
filingsMaintain current knowledge of the field and area(s) of
scientific expertise and developmentAssess method performance and
identify issues and propose and implement appropriate remediation
in conjunction with QA and company policies.Familiarity with
statistical concepts and design of experiments (DoE) related to
functional cell-based assay development, optimization, and
validation.Qualifications:Ph.D. in Biochemistry, Cell Biology, or a
related field with 5 or more years of experience in an industrial
settingExperience working in a regulated pharmaceutical industry
settingGene and/or cell therapy experience preferredExtensive
hands-on experience with the design, development, optimization,
qualification and validation of novel bioassays and immunoassays
across multiple platforms and technologies (e.g, ELISA, MSD, flow
cytometry and cell based - proliferation, phosphorylation, reporter
and cytotoxicity assays)Knowledge of GMP as relevant to laboratory
practices in sample handling and analysis of GLP and GMP
samplesKnowledge of industry USP/ICH guidances for the development,
qualification/ validation of functional cell-based assays and
potency methodsHigh competence in common software and data analysis
packages (e.g., PLA software, SoftMax Pro, GraphPad Prism, JMP,
Microsoft Office tools)Excellent organizational, documentation, and
communication skills; adaptive learning, critical thinking, and the
ability to work well in a teamLI-KO1EEOC 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.Job InfoType: Full timeLocation:
Cambridge, MA
Keywords: Intellia Therapeutics, Somerville , Associate Director, Potency Analytical Development, Executive , Somerville, Massachusetts
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