Principal Research Associate, Analytical Technical Operations
ModernaTX, Inc.

Norwood, Massachusetts

Posted in Science and Research


This job has expired.

Job Info


The Role:

Moderna is seeking a Principle Research Associate based at their Norwood, MA site. The individual in this role will focus on support of Analytical Technical Transfer activities including method lifecycle projects (Acquisition, Qualification, Optimization and Troubleshooting). The individual will coordinate across teams to meet business objectives and may support daily operations as needed.

Here's What You'll Do:

  • As part of the Tech transfer group, your primary responsibilities will be as follows:
  • Lead efforts in support of Method Acquisitions and Method Qualifications in a fast-paced environment.
  • Author method qualification protocols and reports.
  • Execute method qualification studies and perform statistical data analysis.
  • Manage method troubleshooting, remediation, change and optimization efforts in conjunction with Analytical Development.
  • Monitor and communicate method lifecycle (acquisition, qualification, implementation) timelines using project management tools.
  • Authors Equipment and Method SOPs.
  • Troubleshoot methods and equipment.
  • Train analysts to perform testing.
  • This role may also perform the following as directed by management:
  • Analytical testing in support of method lifecycle projects as directed by management.
  • Review of Executed assay packages, in both paper and electronic formats. Includes review of chromatography data and other analytical outputs.
  • Author quality systems records such as deviations, change controls, CAPAs.
  • Author Instrument Qualification documentation, Computer system validation documents and method lifecycle documents.
  • Participate in cross functional planning to align resources and constraints with business objectives.
  • Performs data entry, analysis, trending and review using electronic and paper systems.
  • Establish and maintain a safe laboratory working environment.
  • Other responsibilities as needed.

Here's What You'll Bring to the Table:
  • Minimum education required: Bachelor's degree in a relevant scientific discipline
  • Minimum experience required: BA: 5-8 years, in a GMP laboratory setting focused on analytical chemistry.
  • Demonstrated proficiency with early and late phase method qualifications / validation studies.
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
  • Strong technical writing skills.
  • Strong technical background in HPLC/ UHPLC / Karl Fischer / GC (etc.) Instrumentation/ Software, and method acquisition.
  • Experience with Reference Standard and Assay Control programs is a plus.
  • Proficiency with Microsoft Office Programs
  • Strong written and oral communication skills as well as organizational skills
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.a

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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