Engineer III, Process Development

The Role

Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines.  We are seeking a highly skilled and motivated Engineer III to join Moderna’s Technical Development organization in Norwood, MA.

In this role, you will support the development of manufacturing processes for Moderna’s mRNA-based medicines to enable clinical and commercial supply, with a focus on process understanding and process control strategy definition, and the optimization, transfer, and characterization of manufacturing processes. The role will additionally interface with and support cross-functional teams across CMC, Research and Development, Pre-clinical and Clinical Manufacturing, Quality, and Analytical Development.

Applicants must have demonstrated experience in designing, executing, and analyzing scientific experiments. Applicants must have previous experience with chromatography, nanoparticle formulations, filtration technologies, mixing technologies, and/or statistical design of experiments. Relevant academic and/or industrial experience in drug substance or drug formulation/delivery development is expected. Applicants should enjoy working in a fast-paced, highly dynamic, and innovative environment.  Collaboration through cross-functional matrix teams is required. Applicants should have exceptional time management and communications skills, with a strong attention to detail.

Here’s What You’ll Do

• Design, execute, and analyze experiments for existing and novel process modes

• Develop commercial manufacturing processes, characterize the process design space, and define critical process parameters

• Collect, archive, process, and organize samples for downstream analyses

• Maintain good documentation practice through electronic lab notebooks and technical reports

• Clearly communicate results to a wide audience, both internally and cross-functionally

• Execute and troubleshoot standard protocols, and develop and adapt new protocols into practice

• Maintain positive relationships with internal business partners to facilitate collaborative development across all functions

• Deliver reproducible and impactful results under ambitious timelines

• Support global site startup activities via tech transfer, process investigations and provide person-in-plant support may require domestic or international travel (up to 15% of working time).

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Basic Qualifications)

• BS or MS in chemical engineering, biological engineering, chemistry, biochemistry, or closely related field

• BS with 5+ years, or MS with 2+ years of relevant industry experience in bioprocess development, pharmaceutical development, or closely related area

• Hands-on experience with chromatography, ultrafiltration, normal flow filtration, and/or development of innovative unit operations or experience in nucleic acid drug development (DNA, RNA, oligonucleotides) and/or nanoparticle delivery.

• Experience in designing, executing, and analyzing scientific experiments

• Experience in laboratory work and knowledge of appropriate laboratory hygiene

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Excellent technical writing and verbal communication skills

• Strong interpersonal skills in dynamic settings

• Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data

• Experience in technology transfer and optimization of manufacturing processes.

• Experience with analytics and biophysical characterization of nanoparticles

• Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid