Sr. Specialist, External Manufacturing, US Supply Chain, Critical Raw Materials

The Role:

Reporting to the Sr. Manager (External Manufacturing, US Supply Chain, Critical Raw Materials), the Sr. Specialist will be part of a team responsible for the oversight, performance, and results of Modernas external manufacturing partners and Contract Manufacturing Organizations (CDMO). This role is responsible for ensuring on time and in full delivery of critical raw materials from external partners with the Moderna supply chain network.

Heres What Youll Do:

• Partner with Technical Development, Global Material Planning, Quality, and Regulatory to support GMP production activities at Modernas critical material CDMOs/suppliers.

• Ensure operational and technology transfer activities are performed completely and compliantly at CDMOs to deliver a quality product and meet Moderna requirements

• Coordinate CDMO/supplier team, including scheduling and facilitating meetings, sending out agendas, writing and distributing minutes, managing team documentation, and tracking goals and action items

• Coordinate reviews and approvals of various documentation from CDMOs

• Collaborate with internal cross-functional team to own and drive forward internal change controls to support process, equipment, specification, and/or packaging changes at the CDMOs

• Collaborate with Technical Development and External Quality to coordinate investigations and troubleshooting efforts at CDMOs. Initiate and own internal deviations as required

• Drive for and implement agreed continuous improvements at CDMOs

• Coordinate and perform the reviews for process performance and Key Performance Indicators at CDMOs

• Collaborate with Technical Development, External Quality, and Global Material Planning to support batch release, shipping, and disposition activities at CDMOs as applicable

• Collaborate with Global Material Planning, Finance, Logistics, and Accounts Payable to ensure on-time invoice payment

• Author and revise SOPs and/or other GMP and non-GMP documentation as required

• Frequently visit and maintain a presence at the external partners sites, as the global travel situation allows.

• Performs other administrative/managerial duties as required.

Heres What Youll Bring to the Table:

• Associate degree in Engineering, Supply Chain or Sciences with PMP or similar certification 57 years of industry experience. Bachelors degree in Engineering, Supply Chain or Sciences and 3-5 years or MS with 1-3 years of industry experience.

• Project management experience highly preferred

• Comprehensive understanding of regulatory requirements and their applications in a cGMP environment

• Excellent written and oral English language skills

• Demonstrated ability to lead and support cross-functional teams and deliver results with minimal supervision

• Ability to manage multiple priorities in a fast-paced 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

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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