• Job Description

  Req#: R13948

  The Role:

  Moderna’s R&D Quality (RDQ) group is seeking a highly motivated 3rd/ 4th year colleague student that has an interest in Quality Assurance in the R&D environment within the biotech/pharma industry. This position provides an opportunity for inquisitive students who are currently pursuing a Biology, Chemistry, or Pharmacy degree to get hands on experience working with a R&D Quality team in a fast-paced environment providing proactive compliance guidance and support across all RDQ GXPs (GCP/GLP/GVP/CSV). The R&D Quality intern will also contribute to key development projects and help advance the overall maturity of our program.

  If you are bold, relentless, collaborative, and obsess over learning, an internship at Moderna can help augment your education and accelerate your career.

  Our Winter/Spring co-op program will run from January 16 – June 14, 2024. All applicants must be available to work full-time for the entire duration of the program.

  The R&D Quality Co-Op will focus on assisting RDQ staff in updating audit trackers, preparing documentation for audits, and assisting in development of periodic regulatory updates. This Co-Op will also assist with supporting Health Authority inspections and the migration of data into the Veeva Audit Management System. The internship will also provide the opportunity for the intern to shadow experienced RDQ Auditors in conducting clinical study, vendor, and pharmacovigilance audits. The intern must also be able to interact and collaborate effectively in a dynamic, cross-functional matrix environment.

  Here’s What You’ll Do:

  • Train in the conduct of clinical (GCP) audits (non-travel)

  • Assist in updating audit trackers

  • Assist in drafting documentation for Moderna conducted audits

  • Learn about current regulatory requirements by assisting in the development of quarterly newsletter and regulatory intelligence activities

  • Learn about Quality study team support

  • Accept candid feedback and look for areas of improvements

  • Participate in other departmental initiatives and meetings as assigned

  • Assist in preparation for Health Authority inspections

  • Assist in migration of data into the Veeva Audit Management System

  Competencies and Benefits of this Internship:

  • Gain real life experience in a dynamic and growing R&D quality function that supports clinical trials, non-clinical laboratories and pharmacovigilance activities

  • Work closely with seasoned R&D Quality professionals that will provide excellent mentorship opportunities through a variety of lenses and experiences

  • Receive training and gain firsthand experience with R&D Quality across the various GXPs (GCP/GLP/GVP/CSV)

  • Gain a keen understanding of the audit process and opportunities to shadow auditors during audits.

  • Exposure to the various GXP functional groups that RDQ supports

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

  • Currently enrolled as a student working towards a Bachelor’s degree in Biology, Chemistry, Pharmacy

  • At least 3 years of study in one of the above scientific fields preferred

  • Basic familiarity with pharmaceutical regulations (GCP,GVP,GLP, CSV) is a strong plus

  • Must possess excellent organization skills and ability to manage multiple priorities

  • Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts

  • Willingness to learn, be mentored, and improve

  • Ability to work independently and in collaborative team environments

  • Ability to work in a fast-paced demanding environment

  • Ability to prioritize based on shifting demands

  • Ability to work independently, prioritize, multitask, know when to ask for help

  • Willing and able to relocate to Cambridge, MA for the co-op

  • Indefinite right to work in the United States without the need for sponsorship now or in the future.

  Moderna is pleased to provide you with an innovative suite of benefits, including:

  • Free premium access to meditation and mindfulness classes
  • Free parking or subsidized commuter passes
  • Generous paid time off, including:
    • Vacation, sick time and holidays
    • Volunteer time to participate within your community
    • Discretionary year-end shutdown
  • Location-specific perks and extras!

  About Moderna

  Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

  By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
  
  We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
  
  If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

  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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

  #LI-HS1

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• About the company

  091 Moderna, Inc., is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines.

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