Principal Research Associate, Analytical Development
ModernaTX, Inc.

Norwood, Massachusetts

Posted in Science and Research


This job has expired.

Job Info


The Role:

Moderna is seeking a Principal Research Associate (PRA) with expertise in technical writing for a position based at their Norwood, MA site. The individual in this role will be responsible for writing standard operating procedures, manages documentation compliance and change control. Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs and SOPs. Must perform all work independently with minimal supervision.

Here's What You'll Do:

  • Monitor updates to compendial chapters and updating QC SOPs accordingly
  • Drafting new SOPs, qualification and validation protocols and reports.
  • Authoring Quality Event (Change controls CAPAs, deviations) for method-related changes.
  • Periodic reviews of current Test Methods and SOPs
  • CMC Filing support

Here's What You'll Bring to the Table:
  • BS with at least 5 years of industry experience, or MS with at least 3 years of industry experience (Chemistry, Biochemistry, Molecular Biology, or related science),)
  • Previous technical writing experience required. Must have writing and/or performing analytical, molecular, biochemical, biophysical and/or cellular assays.
  • Experience with Veeva or similar quality documentation system.
  • Experience with ELISA and PCR/qPCR assays
  • Experience with HPLC / UHPLC assays
  • Ability to work independently and effectively in a highly dynamic environment
  • Excellent communication, presentation, and writing skills
  • Creative/innovative/problem solver
  • Preferred: Experience with nanoparticle formulations
  • Preferred: Familiarity with nucleic acid and protein chemistry, and analytical characterization of biomolecules

Here's What We'll Bring to the Table:
  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

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.

About Moderna

In 10 years since its inception,Modernahas transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.Modernamaintains 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 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 auto-immune diseases.Modernahas been named a top biopharmaceutical employer bySciencefor 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.

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This job has expired.

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