Sr. Specialist, Manufacturing

The Role:

ModernaTX, Inc. seeks a Sr. Specialist, Manufacturing for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• Determine root cause of DNA, Drug Substance and Drug Product Manufacturing issues using Root Cause Analysis tools.

• Practice and promote safe work habits and adhere to safety procedures and guidelines.

• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events.

• Lead cross-functional teams to drive complex investigation close outs, determine root causes and implement appropriate Corrective and Preventive Actions (CAPAs).

• Conduct document revisions and/or document management including batch production records and manufacturing procedures.

• Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues.

• Follow-up on requests, issues, and projects and report statuses to manager/working teams.

• Perform of metric trending using software dashboards such as Spotfire and Tableau.

• Generate technical protocols and reports and support internal and external audits.

• Manage deviation records through the Moderna electronic Quality Management System.

• Lead cross-departmental technical investigations to troubleshoot and resolve manufacturing issues.

• Train new deviation writers to investigate and manage Good Manufacturing Practices (GMP) manufacturing deviation records.

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

Minimum requirements:

• Requires a Master’s degree, or foreign equivalent, in Biotechnology, Chemistry, or a related field and 2 years of experience as a Validation Specialist, Release Technician, QA Specialist, Product Development Associate, Intern – Change Control, or related position.

• In the alternative, employer will accept a Bachelor’s degree, or foreign equivalent, in the specified fields and 4 years of the specified experience.

• Must have at least 1 year of experience with:

  • Quality assurance and validation in support of pharmaceutical production;

  • Working with cGMP regulations for biopharmaceutical production processes;

  • Creation, utilization, and implementation of Quality Systems including CAPAs, deviations, investigations, change controls, SOP review, & batch record review; and

  • Equipment & Process Validation.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17994) or email resume and cover letter to careers@modernatx.com with subject line: R17994.

#DNI

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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 mor