Engineer

Senior Engineer II, MstModernaTX, Inc. seeks a Senior Engineer II, MST for its Norwood, Massachusetts location.Here's What You'll Do:Lead technical transfer and new process implementation to ensure the robust production of mRNA and lipid nanoparticle (LNP) drug substances using current Good Manufacturing Practices (cGMP). Work collaboratively with cross functional stakeholders including technical development, manufacturing, automation, regulatory, and quality, to ensure all technical aspects of the process are successfully implemented. Collaborate with technical development and process development of mRNA and LNP on material generation for Investigational New Drug (IND) enabling studies. Provide technical support and serve as the subject matter expert for drug substance manufacturing, including supporting equipment commissioning, process transfer, automation recipe implementation, troubleshooting and leading technical investigations. Perform process monitoring, analysis, implementation, and troubleshooting for new process in a validated state using statistical software PI Process book and JMP for creating and analysis of trends. Perform engineering runs and execute on-floor testing/troubleshooting using biomanufacturing instruments such as Spectro-photometers, Optical Density-meters, conductivity meters, pumps and filtration systems, chromatography, tangential flow filtration (TFF), columns and column packing, and AKTA purification system.Collaborate cross functionally on technical deviations and represent as a subject matter expert for drug substance operations on product and process deviations. Provide engineering support for projects for drug substance manufacturing, including the definition of project scope, option analysis, engineering design, execution, and qualification. Create engineering documentation such as URSs and Design Specifications. Author process and equipment risk assessments to support drug substance manufacturing. Provide on-call support for drug substance manufacturing. Support process training for GMP operations and development of process understanding and expertise. Lead and participate in cross-functional teams to improve business practices and drive operational efficiency and effectiveness. Provide technical leadership, mentoring, and coaching of junior department staff. Communicate with leadership to drive alignment of critical decisions, strategy, and risk mitigations. Support sections of regulatory filings and assist in change control management. May telecommute up to two (2) days per week.Here's What You'll Bring to the Table:Minimum requirements:Requires a Master's degree in Biomedical Engineering, Biochemical Engineering, Biotechnology or related field and eight (8) years of experience in the position offered or as a Technical Development Engineer, Biochemical Engineer, Scientist, Specialist or related position.Alternatively, employer will accept a Bachelor's degree in fields specified and ten (10) years of the specified progressive, post-baccalaureate experience.Must have at least 8 years of experience with:Technical transfer of new process and introduction of new manufacturing equipment;Manufacturing support and troubleshooting of drug substance manufacturing processes and equipment during production of batches;Chromatography, Tangential flow filtration (TFF) system, fill finish operations, columns, column packing, spectrophotometers, Optical density meters, conductivity meters, pumps, valves, and filtration systems;Six sigma tools, statistical and data analysis using JMP;Change management and deviation support using quality management systems and cGMP guidelines using VEEVA;Authoring Standard Operating Procedures, User Requirement Specification (URS), Risk Assessments and Product Impact Assessments applying technical knowledge of drug substance manufacturing and equipment for drug substance manufacturing; andVisio, SAP, and automation software in manufacturing.May telecommute up to two (2) days per week.