External Manufacturing Specialist

  • location: Norwood, MA
  • type: Permanent
  • salary: $100,000 - $120,000 per year
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job description

External Manufacturing Specialist

Moderna Therapeutics:
Sr. Specialist / Engineer III, External Manufacturing, US

Reporting to the Senior Manager of US External Manufacturing Fill Finish, the Senior Specialist/ Engineer III
will be part of a team responsible for Moderna's manufacturing activities at 3rd-party contract manufacturing organizations (CMO), with a focus on fill finish.

Here's What You'll Do:

  • Ensure operational and technology transfer activities are performed completely and compliantly at CMOs to deliver a quality product and meet Moderna requirements
  • Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality.
  • Approve instructions relating to external production operations and ensure their strict implementation by the CMOs
  • Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna's requirements.
  • Coordinate and perform the reviews for process performance and Key Performance Indicators at FF CMOs.
  • Drive for and implement agreed continuous improvements at FF CMOs.
  • Coordinate reviews and approvals of various documentations from FF CMOs.
  • In collaboration with Quality, Technical Development, and MS&T, coordinate investigations and troubleshooting efforts at FF CMOs.
  • Write or revise the appropriate GMP documentations.
  • Frequently visit and maintain presence at the external partners??? sites (as global travel situation allows).
  • Performs other administrative duties as required.

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

  • Bachelor's degree in Engineering or Sciences and 5-8 years or MS with 2-5 years of industry experience.
  • Considerable understanding of concepts and principles related to fill finish is preferred
  • Excellent communication skills (verbal and written) to collaborate with CMC Management in a dynamic, cross-functional matrix environment.
  • 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.

Here's What We'll Bring to the Table:

  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for Moderna Month (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • ?Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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