Manufacturing Associate I, Drug Substance Operations at ModernaTX, Inc. in Norwood, Massachusetts

Job Description:

The Role



In this role, you will execute, under close supervision, all applicable manufacturing unit operations, as directed, following relevant standard operating procedures and cGMP regulations. The work is conducted within a clean-room environment and typically involves limited physical activity, lifting and standing for periods of time.



Here's What You'll Do

• Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
  
  


• Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  
  


• Execute tasks precisely. Utilizing reader-doer for all steps outlined in standard operating procedures, work instructions, and batch execution documentation. Readers are responsible for SOP and batch record compliance, verifying the actions of the Doer, and are accountable for the outcome of the tasks. Doers are responsible for task execution, are expected to understand the task's purpose and are expected to be able to anticipate system response once actions are performed.
  
  


• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  
  


• Working in grade C environments and ensuring the manufacturing area is clean and remains in a state of control.
  
  


• Adhere to documented waste handling procedures and respect environmental regulations.
  
  


• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.
  
  


• Once trained, utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
  
  


• Understands physical and digital systems governing equipment and processes to enable basic troubleshooting.
  
  


• Perform specific unit operations in which they are fully trained.
  
  


• Aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies including chromatography, multiple filtration methods and nano-mixing operations.
  
  


• Filling and dispensing activities to final container closure for finished clinical and commercial drug substance prior to forward processing.
  
  


• No delegation or approval responsibilities associated with this role.
  
  


• Additional duties as may be assigned from time to time
  
  

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

• • Education: HS Diploma
  
  


• • Experience: STEM degree with 0-1 years' industry experience or an Associates' degree with 2-3 years' industry experience or HS Diploma with 3-5 years' industry experience
  
  

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

• Demonstrated ability to learn to gain a strong understanding of GMP regulations.
  
  


• 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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