Moderna · 12 hours ago
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.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
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
Qualification
Required
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
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Recent News
Benzinga.com
2026-01-16
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