Senior Engineer II, MST Position Available In Norfolk, Massachusetts

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 careers@modernatx.

com 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 leavesandaccommodations@modernatx.com. 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. #LI-RB1 – Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission:

To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision:

To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home