Moderna
Senior Research Associate, Manufacturing Science and Technology (MS&T) - Validation
This job is now closed
Job Description
- Req#: R14651
Conduct process risk assessments and develop strategies to mitigate risks and improve process robustness.
Begin overseeing the application of validation methods across new drug product manufacturing lines.
Start creating procedure-type documents and training support materials.
Analyze process data, perform statistical analysis, and generate reports supporting process characterization and validation activities.
Assist in commissioning, qualification, and validation activities for the drug product premises.
Develop and implement knowledge management programs focusing on manufacturing operations.
Provide technical expertise for manufacturing operations, troubleshooting process-related issues, and identifying root causes.
Collaborate closely with the Quality Assurance team to ensure cGMP and regulatory compliance.
Support technology transfer activities from development to commercial manufacturing, ensuring successful process transfer and implementation.
Train manufacturing personnel on new processes, equipment, and technologies.
Bachelor's or Master's degree in a scientific or engineering discipline (Chemical Engineering, Pharmaceutical Sciences, or related field).
Experience in a pharmaceutical manufacturing environment, preferably in a role related to aseptic fill finish process, process optimization, or technical support.
Experience with creating and delivering training programs.
Familiarity with process validation principles and statistical analysis techniques.
Proficient in data analysis software and statistical tools.
Excellent problem-solving and troubleshooting skills.
Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Quality healthcare and insurance benefits
- Lifestyle Spending Accounts to create your own pathway to well-being
- Free premium access to fitness, nutrition, and mindfulness classes
- Family planning and adoption benefits
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
- Educational resources
- Savings and investments
- Location-specific perks and extras!
About the company
091 Moderna, Inc., is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines.
The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is committed to enhancing Australia's biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility is set to be a key player in Australia's response to future health threats. This collaboration emphasizes not only cutting-edge medical technology but also job creation and local talent development. We invite visionary professionals to join us on this transformative journey and make a tangible impact on global health security.
Moderna is seeking a Senior Research Associate Validation for our new manufacturing site in Melbourne, Australia. This role involves ensuring the consistent application of validation methods, creating procedure documents, and implementing training programs for a new drug product manufacturing line project.
Here's What You’ll Do:
Within 3 Months, You Will…
Within 6 Months, You Will…
Within 12 Months, You Will:
Here’s What You’ll Bring to the Table:
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
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.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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
-