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Principal Research Associate, Analytical Science & Technology

Company

Moderna

Address Norwood, MA, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research
Expires 2023-11-18
Posted at 9 months ago
Job Description
The Role:


Moderna is seeking a Principal Research Associate based at their Norwood, MA site. The individual in this role will focus on support of Analytical Tech Transfer activities. The individual will coordinate across teams to meet business objectives.


Here’s What You’ll Do:
  • Support responses to compliance audits.
  • Support efforts for method troubleshooting, remediation, change and optimization efforts in conjunction with Quality Control and Analytical Development.
  • Author Qualification Master Plans.
  • Monitor and communicate method lifecycle (acquisition, transfer, qualification / validation, implementation) timelines using project management tools.
  • Provide CMC Filing Support, including INDs, BLAs, etc.
  • Coordinate AS&T lab method readiness activities and project timelines.
  • Act as the liaison between Analytical Development and AS&T Functions.
  • Coordinate training between development and AS&T teams.
  • Coordinate SME to SME discussion and collaboration with internal and external teams.
  • Maintain a safe laboratory working environment
  • Lead the Program Management for internal Analytical method transfers and qualification activities into AS&T and out to QC labs.
  • Project management of external analytical method transfers and co-qualifications at external CMOs and CTLs.
  • Lead cross-functional meetings between AS&T and support groups.
  • As part of the Analytical Science & Technology team, your primary responsibilities will be as follows:
  • Other responsibilities as needed.


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


  • Demonstrated knowledge of method transfer activities.
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
  • Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
  • Excellent communication skills (verbal and written)
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Minimum Education requires: Bachelor’s degree in Sciences and 5-8 years of industry experience in a cGMP laboratory setting focused on analytical chemistry.
  • Minimum education required: Bachelor’s degree in a relevant scientific discipline


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
  • 401k match and Financial Planning tools
  • Location-specific perks and extras!
  • Discretionary year-end shutdown
  • 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
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Dedicated care coordination support for our LGBTQ+ community
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Exclusive preferred pricing on Peloton fitness equipment
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Paid sabbatical after 5 years; every 3 years thereafter
  • Free parking or subsidized commuter passes
  • Generous paid time off, including:
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • Adoption and family-planning benefits
  • Volunteer time to participate within your community
  • Vacation, sick time and holidays
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options


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 [email protected]. (EEO/AAP Employer)


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