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 method qualification/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:
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-AM1