Sr. Research Associate, Analytical Development at Moderna Therapeutics in Norwood, Massachusetts

Job Description:

The Role:

The primary responsibilities of this role will be generating and reviewing method performance data to support late phase test method robustness assessment and close gaps identified during method transfer. Further responsibilities include issuing tech memos and analytical reports to support regulatory filings and performing data analysis using biostatistical tools to support process development and specification setting.

These efforts will be focused upon both formulated mRNA products and mRNA drug substance and will support late phase development programs within Moderna's Technical Development group. Analytical development in Technical Development is structured around a "Centers of Emphasis" model and accordingly the individual will liaise with the appropriate functional groups to drive any method evaluation and optimization efforts for the programs that they are responsible for.

This role will be located at the new Moderna Technology Center in Norwood, MA. The individual will be a great contributor to late phase mRNA drug development by providing all necessary analytical support to the process development, manufacturing, quality, and regulatory teams.

Here's What You'll Do:

• Perform release and stability HPLC/UPLC test methods to support method robustness assessment for late phase programs.




• Review analytical method performance data on non-GMP materials to close gaps identified during method transfer.




• Draft tech memos and analytical reports to support regulatory filings and internal communications.




• Review and compile non-GMP stability data for development batches.




• Perform data analysis using biostatistical tools to support assay performance assessment, process development and specification setting.




• Work collaboratively with other member within Analytical development and Process development organizations.




• Presentation of results at internal meetings.

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

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  BS with 2-5 years or MS with 0-2 years of relevant industry experience in analytical development.

  
  
  
  

  • BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.

  
  

  • Knowledge and hands-on experience in analytical techniques including spectroscopy (UV, Fluorescence) and separation techniques (UPLC, HPLC, CE).

  
  

  • Experience in early and late phase drug development.

  
  

  • Knowledge of the regulatory guidelines on analytical method development, method qualification and method validation.

  
  

  • Knowledge and extensive hands-on experience of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Empower and Openlab).

  
  

  • Familiarity with electronic notebooks, LES and LIMS.

  
  
  
  



• Excellent interpersonal and collaborative skills.




• Ability to work with limited supervision and effectively in a highly dynamic environment.

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)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, 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. 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 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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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