Manager, External Chemistry Operations

The Role

In this role, you will be part of a team responsible for the day-to-day oversight and coordination of Moderna’s external manufacturing partners and Contract Development and Manufacturing Organizations (CDMOs). This role ensures timely and accurate delivery of raw materials from external partners within the Moderna supply chain network.

Here’s What You’ll Do

• Partner with Technical Development, Process Chemistry, Supply Chain, Manufacturing Science and Technology (MS&T), Quality Assurance and Quality Control, and Regulatory to manage GMP production activities at Moderna’s critical material CDMOs/suppliers.

• Ensure operational activities are performed completely and compliantly at CDMOs to deliver quality products 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 teams to support process, equipment, specification, and/or packaging changes at the CDMOs.

• Address and resolve supply bottlenecks at CMOs in collaboration with Quality and MS&T.

• Implement agreed continuous improvements at CDMOs, focused on product quality and supply reliability.

• Perform reviews for process performance and Key Performance Indicators at CDMOs.

• Coordinate with MS&T, External Quality, and Supply Chain for batch release, shipping, and disposition activities at CDMOs.

• Collaborate with Supply Chain, 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.

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

• Support the CDMO sourcing evaluation process.

• Assist in the operational onboarding of new CDMOs.

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Basic Qualifications)

• Bachelor’s degree in Engineering, Chemistry, Pharmacy, Pharmaceutical Sciences, or similar and at least 8 years of relevant industry experience, MS with 5 years of relevant experience.

• This role is based in Norwood, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Project management experience highly preferred.

• Strong business acumen.

• Understanding of regulatory requirements and their applications in a cGMP environment.

• Excellent written and oral English language skills.

• Ability to travel and support critical activities in-person at CDMO sites.

• Demonstrated ability to 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.

• 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