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Scientist, Molecular Assays Jobs

Company

Moderna

Address Cambridge, MA, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research
Expires 2023-06-14
Posted at 1 year ago
Job Description
The Role:
Moderna is seeking an experienced Molecular Assays scientist I to join the 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:
  • Establish internal and external mRNA based bioanalytical capability and facilitate method development to support Moderna’s portfolio.
  • Responsible for the design and effective execution of phase-appropriate biochemical and molecular biology assays to enable pharmacokinetic/pharmacodynamic (PK/PD) analysis, including genomic DNA and RNA isolation, qPCR, ddPCR, NGS sequencing, ELISA, immunoblotting and other relevant technologies.
  • 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.
  • Responsible to ensure assays are developed in a timely manner to meet program timelines, the qualification or validation of assays is fit for purpose within GcLP compliance for clinical use and troubleshoot any issues that arise internally or with external CRO partners
  • Responsibilities also include analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination, and control of critical reagents for example.
  • Collaborate with clinical operations and sample management to define sample journey and develop appropriate laboratory manuals.
  • Evaluate and review raw data and study analytical reports and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Moderna standards and that data are of the required quality (regulatory and scientific).
Here’s What You’ll Bring to the Table:
  • Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment.
  • Knowledge of GcLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.
  • Experience with RNA, biologics and cell therapy preferred
  • Experience in RT-PCR, ddPCR, NGS sequencing and other methodologies for clinical assays and basic validation principles
  • A Ph.D. in Molecular Biology or relevant scientific discipline from the following areas: infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 3+ years of industry biotech/pharmaceutical experience. M.S. with a minimum of 7+ years of bioanalytical and GcLP/GLP experience are considered
  • Working knowledge of the translational literature and competitive landscape in the RNA therapeutic field.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Exclusive preferred pricing on Peloton fitness equipment
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • Free parking or subsidized commuter passes
  • Vacation, sick time and holidays
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Location-specific perks and extras!
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Highly competitive and inclusive medical, dental and vision coverage options
  • Generous paid time off, including:
  • 401k match and Financial Planning tools
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Paid sabbatical after 5 years; every 3 years thereafter
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Adoption and family-planning benefits
  • Discretionary year-end shutdown
  • Volunteer time to participate within your community
  • Dedicated care coordination support for our LGBTQ+ community
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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