Engineer II, Drug Product, Manufacturing Science and Technology (MSAT), Formulation
About The Position
The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. As a Process Expert in Formulation, you’ll bring deep technical insight into Moderna’s aseptic operations by focusing on the development and execution of drug formulation and filling processes, particularly those using single-use mixers and materials. Based at our Norwood facility, you will support GMP manufacturing operations and collaborate with cross-functional teams to ensure robust process performance. This is a key individual contributor role, blending hands-on troubleshooting, document ownership, and audit readiness. You’ll work closely with Technicians and Process Experts to ensure excellence in sterile drug product formulation while playing a visible role in operational problem-solving, continuous improvement, and quality assurance. This position provides a unique opportunity to interface directly with Generative AI-enhanced digital systems used across our documentation and monitoring platforms.
Requirements
- Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
- A minimum of 1-3 years of experience in the biotech or pharmaceutical industry, with a focus on drug formulation and filling processes.
- Experience with single-use technologies in a pharmaceutical manufacturing environment.
- Strong understanding of GMP regulations and guidelines.
- Proven ability to troubleshoot issues related to single-use technologies.
- Strong written and verbal communication skills.
Responsibilities
- Providing technical expertise and quality-related support for sterile drug formulation processes, with a focus on the use of single-use mixers and materials.
- Acting as Subject Matter Expert (SME) and Standard Operating Procedure (SOP) writer for formulation procedures within GMP environments.
- Supporting deviation investigations and executing corrective and preventive actions (CAPAs) when required.
- Collaborating with Process Experts and Technicians across the organization to ensure seamless production performance and knowledge sharing.
- Conducting proactive process monitoring and executing troubleshooting during GMP manufacturing to maintain high performance of formulation processes.
- Drafting, reviewing, and approving GMP-compliant documentation tied to formulation and filling activities.
- Serving as a technical point of contact during internal and external audits.
- Managing interactions between Operations and the Quality Organization to resolve technical or procedural gaps in a timely manner.
Benefits
- Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
