Associate Director, Genetic Assays

The Role:
Moderna is seeking an experienced Bioanalytical and Molecular Sciences expert to join the Clinical Bioanalytical team to lead Genetics assay based bioanalysis under GLP/GcLP compliance as the Associate Director, Genetic Assays. A successful incumbent will provide Scientific and operational oversight of mRNA, pharmacokinetic (PK) and routine biomarker bioanalyses for Moderna m RNA based therapeutic pipeline.
Here’s What You’ll Do:

• Leads the Molecular team 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, sequencing and other relevant technologies.
• Assist in writing regulatory submissions and in responding to regulatory queries when needed.
• 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 clinical use and troubleshoot any issues that arise internally or with external CRO partners
• Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.
• Establish PCR based GLP/GCLP regulated capability and facilitate method development and validation to support clinical programs. Responsible for in-house GLP/GCLP infrastructure, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities assuring phase appropriate approach.
• Responsibilities also include analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination, and control of critical reagents for example.

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

• Expert knowledge of RT-PCR, digital PCR, RNA sequencing, Simoa, Luminex and other methodologies for preclinical and clinical assays.
• Experience with RNA, biologics and cell therapy preferred
• A Ph.D. in infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 10+ years of industry biotech/pharmaceutical experience. M.S. with extensive bioanalytical experience are considered
• Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.
• 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.

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

• Discretionary year-end shutdown
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• 401k match and Financial Planning tools
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Vacation, sick time and holidays
• Generous paid time off, including:
• Paid sabbatical after 5 years; every 3 years thereafter
• Free parking or subsidized commuter passes
• Volunteer time to participate within your community
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Location-specific perks and extras!
• Highly competitive and inclusive medical, dental and vision coverage options
• Free premium access to fitness, nutrition, and mindfulness classes
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Exclusive preferred pricing on Peloton fitness equipment
• Dedicated care coordination support for our LGBTQ+ community
• Adoption and family-planning benefits

About Moderna
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 a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)
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