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
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is http://www.modernatx.com.
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