Specialist, DP Manufacturing at ModernaTX, Inc. in Norwood, Massachusetts

Job Description:

The Role



In this role, you will support clinical manufacturing operations at our GMP Manufacturing site. This role is pivotal in overseeing vial filling, visual inspection, labeling, and packaging operations essential for the evaluation of human clinical trials. The Specialist will leverage their expertise in manufacturing practices, bioprocess unit operations, process engineering, and digital systems to provide technical leadership. They will be instrumental in developing operational procedures, training manufacturing associates, supporting technology transfer activities, and leading projects aimed at achieving efficient, Right First-Time results.



Here's What You'll Do

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


• Provide on-the-floor coaching for the manufacturing team in process execution, troubleshooting, cGMPs, and safety practices.
  
  


• Lead tech transfers and serve as the manufacturing lead on various projects.
  
  


• Lead and participate in cross-functional teams to drive changes, improvements, and resolve complex manufacturing operation issues.
  
  


• Develop batch records, SOPs, and training materials in collaboration with process SMEs.
  
  


• Partner closely with QA to ensure rapid disposition of batches, including timely reviews of batch records, protocols, and supporting deviation investigations.
  
  


• Manage CAPA implementation and own the resolution process for manufacturing deviations.
  
  


• Manage change controls and oversee the introduction of simple equipment/tools.
  
  


• Prepare operations for new product introductions, technology transfers, and major capital projects.
  
  


• Participate in equipment startup, commissioning, and validation activities.
  
  


• Maintain a flexible work schedule to meet production and project demands.
  
  


• Escalate issues potentially impacting business objectives.
  
  


• Additional duties as may be assigned from time to time.
  
  

Here's What You'll Need (
Basic
Qualifications)

• 
  Education: BS in a relevant science or engineering discipline.
  
  


• 
  Experience: 2-3 years in biopharmaceutical operations, with substantial involvement in cGMP environments.
  
  

Here's What You'll Bring to the Table (Preferred Qualifications)

• Training in cGMP practices and familiarity with electronic batch records and 21 CFR part 11 requirements is crucial.
  
  


• Demonstrated ability to work independently with minimal supervision, excellent problem-solving skills, and effective communication and leadership in cross-functional settings.
  
  


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


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

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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)


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