Engineer II, Drug Product, Manufacturing Science and Technology (MSAT), Formulation

Moderna is a pioneering company revolutionizing medicine through mRNA technology, and they are seeking a Process Expert in Formulation. This role involves providing technical expertise in drug formulation processes and collaborating with cross-functional teams to ensure robust process performance in GMP manufacturing operations.

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

Skills

• 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
• Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship

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

Company Overview