Associate Director, Genetic Assays and B
Moderna Therapeutics

Job Order #: 17571405

Cambridge, MA 02141

Full Time

40 hours per week

POSTED 8/27/2022

EXPIRES 11/24/2022

Job Description

The Role:

Moderna is seeking an experienced Genetic Assay and Bioanalytical Sciences Associate Director to join the Pre-Clinical and Clinical Bioanalytical team. A successful incumbent would help integrate basic science research, bioanalysis, genomics, and informatics to move programs into the clinic as well as reverse-engineer clinical findings to novel opportunities for Moderna's pipeline.

Here's What You'll Do:

* Responsible for independently design and execution of phase-appropriate molecular biology assays to enable pharmacokinetic/pharmacodynamic (PK/PD) analysis, including genomic DNA and RNA isolation, qPCR, ddPCR, MSD, ELISA, Simoa, immunoblotting and other relevant technologies.

* Be responsible for the initiation and development of new quantitative genetic assays to support PK analysis in preclinical and clinical studies using RT-qPCR, ddPCR or other new technologies.

* Responsible to ensure assays are developed in a timely manner to meet program timelines, the qualification or validation of assays is fit for purpose in preclinical or clinical use and troubleshoot any issues that arise internally or with external CRO partners

* Establish internal and external mRNA based bioanalytical capability and facilitate method development to support Moderna's portfolio.

* Experience in PCR methodqualification/validation,cell-based assay development such as NAb assay are highly desirable.

* Responsibilities also include analytical equipment procurement/qualifications, preparation and maintenance of SOP's, determination, and control of critical reagents for example.

* Collaborate with preclinical and clinical operations and sample management to define sample journey and develop appropriate laboratory manuals.

* Participate and present results in departmental and cross-functional project team

Here's What You'll Bring to the Table:

* A Ph.D. in genetic assays from the following areas: infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 5 years of industry biotech/pharmaceutical experience. M.S. with extensive bioanalytical experience is strongly preferred

* Experience with RNA, biologics and cell therapy preferred

* Expert knowledge of RT-PCR, immunoassays, Simoa, Luminex and other methodologies for preclinical and clinical assays.

* Working knowledge of the translational literature and competitive landscape in the ASO field.

* Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment.

* Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

* Highly competitive and inclusive medical, dental and vision coverage options
* Flexible Spending Accounts for medical expenses and dependent care expenses
* Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
* Family care benefits, including subsidized back-up care options and on-demand tutoring
* Free premium access to fitness, nutrition, and mindfulness classes
* Exclusive preferred pricing on Peloton fitness equipment
* Adoption and family-planning b
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320 Bent St.
Cambridge, MA 02141

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Karen Shih


Talent Acquisition Coordinator





320 Bent St.
Cambridge, MA 02141