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Sr. Manager, Manufacturing Science and Technology

Moderna
United Statesfull_timeVerifiedPosted 21 Mar 2024

About the role

The Role:

The Sr. Manager, MS&T, will be part of Moderna’s Manufacturing Science and Technology team responsible for process implementation, technical support, and person-in-plant coverage to ensure robust production of our DNA plasmid, chemistry, and small-scale drug substance processes. The individual will lead a team and work collaboratively with cross functional stakeholders such as Technical Development, Manufacturing, Regulatory, and Quality, to ensure all technical aspects of production are successfully executed.   

Here’s What You’ll Do:

  • Provide expertise in unit operations and cGMP manufacturing, responsible for technical support, change control, safety observations, manufacturing investigations, and person-in-plant coverage for the manufacturing process.

  • Support process training for GMP operations and development of process understanding and expertise.

  • Lead/participate in cross functional technical process support and investigation teams. 

  • Partner with Technical Development, Manufacturing, and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.

  • Lead a team of subject matter experts in plasmid, chemistry, and small-scale drug substance processes.

  • Be the subject matter expert for plasmid, chemistry, and small-scale drug substance processes.  This includes troubleshooting process and equipment issues.

  • Independently provide complex technical support of cGMP manufacturing including authoring of complex technology transfer documents, change controls, manufacturing impact assessments, and study protocols.

  • Lead complex analysis and review of data.  Proactively identify improvement projects and performance risks.

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

  • Biochemical engineer, Chemical engineer, Biochemistry, Biology, or STEM background. BS with 8+ years of experience or MS with 5+ years’ experience in a pharmaceutical or biotechnology company.

  • Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.

  • Demonstrated expertise bioprocessing including purification of protein and/or nucleic acids.  Expertise in at least one of the following areas: chromatography, membrane separations, enzymatic reactions, and formulation.

  • Technical agility.  The capability to manage diverse technical areas.

  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

  • Preferred: Expertise in molecular biology

  • Preferred: Experience in biologics process development and scale up / scale down.

  • Preferred: Experience with single use bioprocessing technologies.

  • Preferred: Proven track record leading and managing cross functional teams.

  • Preferred: Knowledge of digital cGMP tools.  For example: SAP, OSI PI(), MES (eBR), Unicorn, eQMS

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

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Company

Moderna

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