Engineer III, Drug Product MS&T at ModernaTX, Inc. in Norwood, Massachusetts

Job Description:

The Role



In this role, you will report to Drug Product Manufacturing Science Technology leader. The incumbent will have the opportunity to contribute to technical support of external drug product manufacturing function in global CMOs for Moderna



Here's What You'll Do

• Support the Drug Product Manufacturing Science leader in various tasks related to technical support of clinical and commercial GMP production at fill finish and label packaging Contract Manufacturing Organizations (CMOs).
  
  


• Act as a counterpart for commercial technical support team member to ensure on-time and in-full deliveries. Partner with Quality, Technical Development, Manufacturing Operation, and Regulatory colleagues on specific aspects of the relationships with the CMOs.
  
  


• Partner with external operation team to ensure operational related activities at the CMOs are conducted to meet Moderna's requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).
  
  


• Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality.
  
  


• Ensure that instructions relating to external production operations are strictly implemented by the CMOs
  
  


• Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna requirements.
  
  


• Support and perform the reviews for process performance at CMOs.
  
  


• Monitor Key Performance Indicators of CMOs.
  
  


• Support preparation of periodic business and operations review meetings.
  
  


• Drive for and implement agreed continuous improvements at CMOs.
  
  


• Coordinate reviews and approvals of various documentations from CMOs.
  
  


• In collaboration with Quality coordinate investigations and troubleshooting efforts at CMOs
  
  


• Write or revise the appropriate GMP documentations.
  
  


• Frequently visit and maintain presence at the external partners' sites and build strong interdependent relationship with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans.
  
  


• Performs other administrative duties as required.
  
  

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

• Bachelor's Degree with 4-8 years of technical experience in biopharmaceutical industry or a Master's Degree with 2-5 years biopharmaceutical industry experience; Degree in Engineering or Life Sciences is preferred
  
  

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

• Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment
  
  


• Ability to work with members of partner organizations (CMOs)
  
  


• Well organized - a natural ability to be organized in how you think, communicate and conduct your work
  
  


• You drive for results - you set a high bar for yourself and others
  
  


• Good critical thinker that can anticipate the needed next step and therefore can work independently
  
  


• A curious mindset that allows you to constantly learn and challenge the status quo
  
  


• Ability to navigate through ambiguity and rapid growth and adapt to change.
  
  


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

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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