The DNA and Chemistry Manufacturing Sciences & Technology (MS&T) team is responsible for ensuring the robust technology transfer and technical support of our plasmid and custom nucleotide platforms in clinical and commercial drug substance cGMP manufacturing. As an Engineer II in MS&T, under direct supervision, you will partner with stakeholders in Process Development, Manufacturing Operations, Regulatory and Quality to ensure all aspects of technology transfer and technical support are successfully executed and will provide engineering support for process equipment used at Moderna's Norwood cGMP manufacturing facilities.
Here's What You'll Do
Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Practice and promote safe work habits and adheres to safety procedures and guidelines.
Execute tasks precisely as defined in internal guiding documents including, but not limited to standard operating procedures (SOPs) and work instructions.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
Support technology transfer projects including coordination of process information exchange, documentation of process parameters, and tracking process performance.
Independently, provide basic technical support of cGMP manufacturing including authoring of simple technology transfer documents, change control, manufacturing investigations and helping validation activities.
Analyze manufacturing performance through data review and analyses. Establish and maintain data repositories.
Collaborate with process development on studies to determine root cause for basic deviations.
Lead a cross functional team for moderately complex troubleshooting and operational improvements to manufacturing equipment.
Lead design and engineering of basic disposable systems used in bioprocessing including aseptic bioprocessing bags and tubing manifolds. Execute basic studies to demonstrate equipment fit and process performance.
Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing.
This role may provide occasional weekend or evening coverage for Manufacturing Operations
Approval authority for forward processing and author impact assessments for deviations for further Quality review. No delegation authority associated with this role.
Additional duties as may be assigned from time to time
Here's What You'll Need ( Basic Qualifications)
MINIMUM EDUCATION: Bachelors Degree
MINIMUM EXPERIENCE: Bachelors Degree (STEM Preferrable) with 3-5 years industry experience or Masters Degree with 1-2 years industry experience
Here's What You'll Bring to the Table (Preferred Qualifications)
Working understanding of GMP regulations
Process development or operational experience in bioprocessing unit operations such as: fermentation, enzymatic reaction, chromatography or tangential flow filtration
Knowledge of data management and statistical analysis
Excellent judgement and ability to communicate manufacturing issues in a scientifically sound way
Excellent communication skills, verbal and written
Ability to manage projects and adapt in a fast-paced environment
Ability to collaborate in a dynamic, cross-functional environment
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.
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 time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
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.
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.
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.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
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 proud to be an equal opportunity workplace and is an affirmative action employer.
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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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. (EEO/AAP Employer)
