Sr. Specialist, External Manufacturing, Commercial Drug Substance Operations

The Role:

Reporting to the Sr. Manager (External Manufacturing, Commercial Drug Substance Operations), 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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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