Staff Process Development Specialist

Who we are: 

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.  

At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. 

Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a #MiracleMaker to join our Process Development team as a Staff Process Development Engineer. As a Staff Process Development Engineer you will be responsible for complex and strategic tasks, including overseeing multiple projects, developing long-term process improvement strategies, and ensuring alignment with organizational goals. All processes must be robust, efficient, and compliant with phase appropriate regulatory standards, with a particular focus on mRNA. Additionally, this role supports interdepartmental biomolecule R&D and CDMO projects, ensuring alignment with Good Manufacturing Practices (GMP) across all process development activities.

How you will make an impact: 

• Lead and manage process development projects from concept through commercialization, adhering to timelines and regulatory constraints.  
• Specification and requirement setting for raw materials, supplies, and equipment for mRNA processing.  
• Develop and analyze product life cycle with emphasis on risk assessment for materials and process.  
• Conduct hands-on experiments to identify inefficiencies and optimize processes. Manage lab-based process development projects, ensuring timely completion and accurate results. 
• Propose innovative ideas and foster meaningful scientific discussions. 
• Identify and optimize processes tailored to the unique characteristics of a variety of mRNA drug substances. 
• Lead and manage complex drug development projects, ensuring alignment with client objectives and regulatory requirements e.g. lead FMEA, Gap assessment, DOEs, etc. 
• Assist in the launching of new NPIs through development and scale-up. 
• Gather and analyze data using statistics, measurement systems analysis, and design of experiments efforts and their associated analysis tools. 
• Collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless roll out of processes into production. 
• Follow design, quality, and safety guidelines based on GMP, regulatory, and ISO guidelines and related Quality and Safety Standards and Practices. 
• Create detailed process documentation including SOPs, Batch Records, Protocols, and Reports and train staff on new processes. Maintain detailed lab notebooks and prepare reports on experimental findings. 

 The skills and experience that you will bring: 

• A Bachelor of Science in scientific field; preferably Molecular Biology, Biochemistry, Chemical Engineering or equivalent with minimum of 8 years of related experience; or 6 years and a Master’s degree; or a PhD with 3 years of <