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Specialist, Quality Control

Employer
Moderna, Inc.
Location
Marlborough, MA
Start date
Feb 22, 2024

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time

Job Details

The Role

Moderna is looking for a Specialist, Quality Control Microbiology for their Marlborough, MA facility. This role will support in-process and release testing for raw material, drug substance and mRNA drug products produced at Modernas commercial manufacturing facility. This position will assist management in ensuring the goals and milestones are met for the QC Microbiology Lab as well as day to day operations and support Modernas Individualized Neoantigen Therapy (INT) program.

Heres What Youll Do

  • Utilize QC Microbiology knowledge and investigational skills to identify and resolve testing issues and drive continuous improvement in laboratory operations.

  • Support testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies.

  • Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.

  • Perform on the job (OJT) training and act as a mentor to other QC Microbiology staff.

  • Assist in equipment qualification / validation activities, including maintenance.

  • Perform routine environmental monitoring and critical utility sampling activities.

  • Conduct analysis of water samples to include TOC, Conductivity, Bioburden, and Endotoxin

  • Work directly with management to ensure QC goals and milestones are met.

  • Lead and organize continuous improvement projects.

  • Troubleshoot issues related to equipment, laboratory procedures, and assay performance.

  • Write/revise SOPs, technical protocols, and reports.

  • Assist with audit preparation and regulatory compliance.

  • Responsible for alarms in the QC Microbiology Lab.

Heres What Youll Bring to the Table:

  • BS in a relevant scientific discipline (Microbiology preferred) with a minimum of 4 years (or MS in a relevant scientific discipline with 2 years) Quality Control experience in a cGMP organizationfocused on Microbiology.

  • Standard microbiological product testing (bioburden, endotoxins, and sterility).

  • Aseptic technique.

  • Proficiency with Microsoft Office Programs.

  • Familiarity with electronic databases (e.g. LIMS, ERP, LMS, or equivalent software).

  • Strong written and oral communication skills as well as organizational skills.

  • Practical working knowledge of QC Microbiological instrumentation and related software.

  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

Desired Attributes:

  • Commitment to safety and quality.

  • Vision for continuous improvement and innovation.

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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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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