Manager, Quality Control

The Role:

ModernaTX, Inc. seeks a Manager, Quality Control for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• On behalf of a global biotechnology company, manage Quality Control Laboratory Events (LE), Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) investigations, along with deviations, change controls, and Corrective and Preventive Actions (CAPAs) within the quality management documentation system.

• Analyze, interpret, and review High-performance Liquid Chromatography (HPLC), Ultra-performance Liquid Chromatography (UPLC), Gas Chromatography (GC), and Liquid Chromatography-Mass Spectroscopy (LC-MS) data/chromatograms to troubleshoot method and equipment issues that arise during analysis.

• Supervise Quality Control (QC) associates and ensure adequate training, fostering a culture of continuous learning and expertise.

• Author, review, and approve critical documents such as Standard Operating Procedures (SOPs), test methods, QC release documents, instrument qualification documentation, computer system validation documents, training documents, and method lifecycle documents.

• Coordinate and manage in-process, release and stability chemistry testing by overseeing testing capacity, managing turnaround times, and ensuring progress is communicated effectively to stakeholders at all levels.

• Conduct regular audits of quality control processes and products, identifying areas for improvement and leading the efforts to implement corrective actions.

• Review executed assay packages, in both paper and electronic formats, including review of chromatography data and other analytical outputs.

• Participate in cross-functional planning to align QC resources and constraints with business objectives and prepare, provide, and manage schedules for testing to meet project timelines.

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

• Minimum requirements: Requires a minimum of a Bachelor’s degree, or foreign equivalent, in Chemistry, Biology, or related field and eight (8) years of progressive, post-baccalaureate experience in the position offered, or as a Chemist, Analytical Chemist/Scientist, or related position in the biotechnology or pharmaceutical industry. 

• Full term of experience must include the following: 

  • High-performance Liquid Chromatography (HPLC); 

  • Ultra-performance Liquid Chromatography (UPLC);

  • Gas Chromatography (GC); 

  • Testing stability products, authoring and reviewing protocols and reports, and monitoring product quality and stability under various storage conditions. 

• Must have 3 years of experience with Liquid Chromatography-Mass Spectroscopy (LC-MS).

• Must be available to work night shifts.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17356) or email resume and cover letter to [email protected] with subject line: R17356.

#DNI

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, 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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
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 contact the Accommodations team at [email protected].  (EEO/AAP Employer) 

#LI-NT1

-