Senior Engineer II, MST

The Role:

ModernaTX, 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; and

• Visio, SAP, and automation software in manufacturing.

• May telecommute up to two (2) days per week.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17977) or email resume and cover letter to [email protected] with subject line: R17977.

#DNI

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Our Working Model 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.  Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. 

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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