Sr. Business Analyst, Global Manufacturing Systems

The Role

Moderna is seeking a Senior Business Analyst to define and deliver Manufacturing strategy across the Moderna Drug Product manufacturing network. This role will be a hands-on leader actively involved in project delivery. The individual will set the overall direction for the technical design, utilization, and expansion of the MES for drug product and label and pack operations at Moderna.

Heres What Youll Do

• 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

• Support the development of new capabilities required to facilitate the Technical Transfer of new programs from Technical 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

• Develop and maintain GMP system documentation and manage supporting compliance activities.

• Assist in the development of business cases for MES deployments

• Assist in the development of internal MES practice processes and SOPs

• Deploying innovative MES solutions for our customer base; finding, sharing, and capitalizing on opportunities for improvement

• Consult and lead end-users in MES best practices for their application in applying OEE and SPC

• Ongoing Continuous Improvements Consultation to business stakeholders and advisors

• Link plant level project teams to global level standards for MES Design/Build/Validate/Go Live

• User Requirements Management Activities, MES Solutions Testing Activities, Support MES implementations

• Work with process/product owners to establish process flow standards in MES

• Oversee build out of process/product offering to be leveraged across multiple manufacturing plants and lines

Heres What Youll Need (Minimum Qualifications)

• Bachelors degree in Engineering, Computer Science, or other technical degree

• Minimum 6 years of experience working with digital manufacturing systems

• Experience authoring Emerson Syncade and/or DeltaV recipes

• Experience with cGMP and manufacturing operations and practices

Heres What Youll Bring to the Table (Preferred Qualifications)

• Deep understanding of ISA 88 and ISA 95 industry standards

• Experience translating and mapping process models to flexible reusable procedural model recipes and physical models for equipment

• An understanding of Good Automated Manufacturing Practices (GAMP) and Computer System Validation (CSV).

• Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions at every level of the organization.

• Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously in a fast-paced environment.

• Experience with OEE, downtime tracking, production scheduling, and/or inventory and production tracking preferred

• Experience with Drug Product and Label and Pack operations preferred.

• Experience with Personalized Medicine preferred.

• 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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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 persons 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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