Senior Engineer I, Manufacturing Sciences and Technology

The Role:
Reporting to the Sr. Director, MSAT Materials, you will join a dynamic and influential team as an experienced engineer or scientist in an individual contributor role based in Norwood.

You will provide technical leadership for consumables and/or raw materials across the material life cycle, from new material introduction and consumable design to investigations, troubleshooting, supplier change assessments, scale-up, and technology transfer.

You will bring a strong background in GMP quality systems, processing equipment, unit operations, and pharmaceutical manufacturing regulatory guidelines, using strong communication skills to lead technical teams and coordinate effectively across functions.

Here's What You'll Do:

• Support and improve business processes for introducing new consumables and raw materials, providing the technical expertise and guidance needed to establish robust unit operations and long-term material strategies. Contribute to consumable design and support scale-up and technology transfer activities, connecting material requirements with manufacturing process needs.
• Troubleshoot process and equipment issues and lead the resolution of internal and supplier deviations. Drive investigations through the identification and implementation of corrective and preventive actions (CAPAs), bringing technical rigor to problem-solving across materials, equipment, and unit operations.
• Lead impact assessments of supplier change notifications and serve as a technical representative in supplier relationships, collaborations, and troubleshooting, coordinating with internal stakeholders to evaluate implications for materials and manufacturing processes.
• Serve as the lead writer for BLA and MMA submissions, including the preparation of clinical and non-clinical overviews and summaries, clinical study reports (CSRs), and other key modules in the Common Technical Document (CTD) format.
• Follow all relevant regulations, guidelines, and company policies to ensure compliance with internal Regulatory, Environmental, Health and Safety (EHS), and current Good Manufacturing Practice (cGMP) requirements.
• Partner with Technical Development, Supply Chain, Procurement, Quality, and Regulatory Affairs to drive a critical materials improvement roadmap encompassing supply chain integration, cost savings and avoidance, and consumables library simplification. Ensure global alignment of testing strategies that meet or exceed regulatory requirements.
• Ensure Extractables and Leachables (E&L) strategies and guidance documents are aligned across sites, kept current, and meet all current regulatory requirements. Work with sites to support site-level ownership of E&L studies and risk assessments.
• Execute tasks precisely as defined in internal guiding documents, including, but not limited to, standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements, ensuring that data, documentation, and records are completed and maintained for business use and remain available to support audits and inspections.
• Complete training in your assigned required learning plan within the defined timelines and according to the prescribed requalification cadence.
• Explore opportunities to apply Generative AI tools, where approved, to technical knowledge synthesis and documentation support, maintaining human oversight and compliance with company policies and Data Integrity requirements.

The key Moderna Mindsets you'll need to succeed in the role:

• "We act with dynamic range, driving strategy and execution at the same time at every step." You will connect long-term material strategies and the critical materials improvement roadmap with hands-on investigations, supplier change assessments, and precise execution of technical responsibilities.
• "We digitize everywhere possible using the power of code to maximize our impact on patients." You will seek opportunities to use digital approaches and approved Generative AI tools to support technical knowledge sharing and documentation workflows while upholding quality and data integrity expectations.

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

• Education: BS/MS in mechanical engineering, material science, or related technical discipline
• Experience: Minimum of 5 years of industry experience in process development, manufacturing, engineering, or similar technical role. 8-12 years preferred.
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP and GMP regulations.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success.

Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.