Associate II, Quality Control, Sample Management

The Role

Moderna is seeking an Associate II Quality Control Sample Management to join their team at the Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs and support the Individualized Neoantigen Therapy program. This position will be 12-h rotational day shift (3223)

Heres What Youll Do

• Sample coordination including cross functional collaboration with internal and external labs

• Receipt, processing, distribution and shipment of the following sample types:

  • In-Process, DS, Formulation and DP

  • Equipment cleaning

  • Stability

  • Raw Materials

• Coordinating domestic and international sample shipments

• Interact with Development teams in a GMP compliant manner

• Inspect product and raw material retention samples

• LIMS (LabVantage) sample logging and result entry

• AQL visual inspection of drug product

• Stability program support

• Controlled temperature unit management, maintenance and troubleshooting

• Clean room gowning

• Managing/stocking of QC lab supplies

• Write/revise SOPs, protocols and reports

• Complete and maintain cGMP documentation for work performed

• Participate in authoring quality systems records such as deviations, change controls, CAPAs

• Support non-conformance investigations

• Establish and maintain a safe laboratory working environment

• This position will support 12-h DAY shift QC Sample Management operations at Moderna

• Additional duties as may be assigned from time to time

Heres What Youll Need (Minimum Qualifications)

• Minimum experience/education required: Bachelors degree in a relevant scientific discipline with 1 to 2 years in a cGMP laboratory setting preferred

Heres What Youll Bring to the Table (Preferred Qualifications)

• Experience with LIMS/LabVantage database, Veeva eQMS systems, Pi and Smartsheets

• Quality Record authoring, editing and troubleshooting to ensure timely completion

• Basic knowledge of Stability ICH requirements

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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. Were 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)

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