Sr. Manager, Global Serialization
ModernaTX, Inc.

The Role:

The Moderna Sr. Manager Global Serialization is responsible for leading Serialization process development, improvement, oversite, management and governance for the Global Organization. Lead a team that serves as center of excellence for product serialization, serial number management processes, track and trace regulations, EU Hub, DSCSA (Serialization, Electronic notification of shipments) laws and Industry standards. This includes supporting new launches across the globe and working closely with regulatory departments to meet today's ever-changing regulations.

Here's What You'll Do:

• Lead a team of assigned subject matter experts and manage the necessary resources / workload within team.
  
• Deliver the team mission of implementing the required serialization process / system setup to ensure unique identification of commercial product across Moderna's Global Network.
  
• Partner with other Supply Chain colleagues, Manufacturing, Quality, Digital, Trade Compliance, and other internal and external resources to be a leader in solving issues related to serialization.
  
• Manage and facilitate the oversite of commercial product Field Alerts / Actions / Recall processes, as required.
  
• Maintain and monitor International Market Monitoring Systems (EMVO portal, IFA Database, etc.) and support serialization systems and personnel.
  
• Support packaging design / specification and labeling requirements related to market specific drug product presentation serialization requirements.
  
• Support the review and approval process for labeling artwork ensuring impact of labeling / printed component implementation / modification / revision is properly assessed and implemented.
  
• Interact and maintain strong partnerships with external suppliers of Fill / Finish operations, printed packaging components, and serialization services, as well as internal stakeholders including Supply Chain Operations, Global Master Data, Digital, Life Cycle Management, Quality, and Regulatory Affairs.
  
• Ensure packaging serialization processes meet regulatory and brand requirements while maintaining continuity of supply and aid in building a platform for onboarding easily within new regions.
  
• In coordination with Moderna Global Master Data and Digital Team, ensure serialization compliance requirements for Moderna's commercial products are met.
  
• Serve as Business Process Owner and Business Lead for global serialization programs.
  
• Continuously monitor changing regulatory guidance related to packaging & serialization while building the Moderna Global Serialization Management Strategy, monitoring serialization business process / business system performance and leading continuous improvement activities for serialized commercial products.
  

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

• Bachelor's Degree in Packaging, Mechanical, or Materials Engineering or related field
  
• 8-12 years' experience in the Pharmaceutical industry with package design and development, material qualification, and equipment validation, including 2+ years with serialization, 3+ years in leadership experience, and project management
  
• Knowledge of cGMP's and associated CMC regulatory considerations in a pharmaceutical environment
  
• Knowledge of the Drug Supply Chain Security Act requirements
  
• Strong communication, collaboration, and team-building skills; ability to connect with all levels of the organization. Ability to influence both internal and external stakeholders.
  
• Strong project management skills
  
• Proven ability to manage multiple high-priority projects with a high degree of effectiveness
  
• Experience working with third party packaging organizations is preferred
  
• Experience with computer systems validation is preferred
  
• SAP ATTP (Advanced Track and Trace for Pharmaceuticals)
  

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)

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 10 years since its inception,Modernahas transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.Modernamaintains 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 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 auto-immune diseases.Modernahas been named a top biopharmaceutical employer bySciencefor 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 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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