Moderna is a pioneering company in mRNA technology, dedicated to revolutionizing medicine with a diverse pipeline of development programs. The role of Engineer II in Drug Product Manufacturing Science and Technology focuses on providing technical expertise and support for sterile drug formulation processes, ensuring high 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
BioSpace is the leading online community for industry news and careers for life science professionals. It was founded in 1988, and is headquartered in San Francisco, California, USA, with a workforce of 11-50 employees. Its website is http://www.biospace.com/.
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