Moderna TherapeuticsManager, Manufacturing Systems (MES)
Reporting to the Sr. Director, Manufacturing and Facility Systems, the MES Manager will lead a team of engineers delivering new capabilities and the continuous improvement of the Syncade MES (Manufacturing Execution system). This role will be a hand-on leader actively involved in project delivery. The individual will set the overall direction for the technical design, utilization and expansion of the MES Systems at Moderna.Here's What You'll Do:
Here's What You'll Bring to the Table:
- Lead automation a team of engineers in the deployment of integrated Batch Records (eBRs), electronic Logbooks (eLogs), and other MES system functionality.
- Support the development of new capabilities required to support the Technical Transfer of new programs from Tech Dev into Manufacturing.
- Ensure robust testing of new configuration features based on structure risk assessments.
- Partner cross-functionally within digital to ensure end-to-end process design and system integration to maximize operational efficiency.
- Identify opportunities to improve existing processes, equipment, systems, and infrastructure by both leveraging and setting industry best practices.
- Provide second and third level advanced platform support to the GMP systems operations team including some off-hours on-call support.
- Work cross functionally alongside Manufacturing, Facilities, MS&T, Quality, IT and other groups as required to determine business requirements and set the strategic direction for MES capabilities.
- Coordinate validation activities in collaboration with Manufacturing, IT and QA
- Develop and maintain the MES platform roadmap including the addition of new technologies, unit operations and future technical upgrades.
- Develop and maintain GMP system documentation and manage supporting compliance activities.
Here's What We'll Bring to the Table:
- A bachelor's degree in Engineering, Computer Science, or other Technical degree.
- A minimum of 10 years of experience authoring MES electronic Batch Records.
- Working understanding of cGMP and manufacturing operations and practices
- An understanding of Good automation Manufacturing Practices (GAMP) and Computer System Validation (CSV).
- Strong communication skills (verbal and written).
- Demonstrated ability to work independently and collaboratively on cross-functional teams
- Computer programming and debugging skills with specific emphasis on Visual Basic or VB Script, C#, SQL, Java, and HTML Style Sheets.
- Experience with Emerson Syncade MES is preferred
- 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)
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 Compan'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.Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
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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