Job Title

Principal Research Associate MS&T DP - Validation page is loadedPrincipal Research Associate MS&T DP - ValidationApply locations Melbourne - Australia Drug Manufacturing time type Full time posted on Posted Yesterday job requisition id R17764The 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 solidifying its presence in Melbourne, a city at the forefront of Australia''s biotech industry. Our Melbourne office focuses on commercial operations, ensuring the delivery of our innovative products to the Australian market. We''re inviting international professionals to join us in our mission of delivering the greatest possible impact to people through mRNA medicines.As a Principal Research Associate, MS&T - Validation, you will be responsible for establishing Drug Product (DP) MS&T activities at our Clayton, Australia site (MTC-M). Reporting to the MS&T Drug Product Site Lead, you will serve as a technical specialist ensuring robust validation practices, technology transfers, continued process verifications, investigations, and change management in support of a new drug product manufacturing line. Your expertise will drive the development of compliant, high-quality systems and processes critical to delivering mRNA products for local and export markets. As a senior team member, you will champion quality culture and contribute to the sites technical leadership.Heres What Youll Do:Your key responsibilities will be:Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities.Ensure manufacturing alignment with mRNA/LNP platform standards, author and review cGMP documentation.Perform risk assessments, generate SOPs, and establish training programs.Monitor key performance indicators to identify and improve inefficiencies.Support operational metrics, departmental budgets, and site planning.Investigate complex manufacturing issues with cross-functional teams.Act as technical expert for audits and inspections.Collaborate with global sites on data sharing and best practices.Integrate Lean and Six Sigma principles for continuous improvement.Execute technical support for media fills, cleaning verifications, and material qualifications.Your responsibilities will also include:Strict adherence to Good Documentation Practices and Data Integrity.Completing training per assigned learning plans and requalification schedules.Maintaining deep expertise in quality systems, cGMP, and industry standards.Performing additional duties as assigned, including exploring opportunities for integration of Generative AI tools to streamline validation and investigation processes.The key Moderna Mindsets you''ll need to succeed in the role:We behave like owners. The solutions were building go beyond any job description. As the Principal Research Associate, you will be pivotal in establishing the foundational validation and MS&T operations at a new site, acting with full ownership over your domain and its strategic impact.We digitize everywhere possible using the power of code to maximize our impact on patients. You will actively seek opportunities to integrate digital and AI tools into validation processes, enhancing efficiency, compliance, and data-driven decision-making to optimize patient outcomes.Heres What Youll Need (Basic Qualifications):Education: Bachelor''s or Master''s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.Experience: A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile manufacturing operations.This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.Heres What Youll Bring to the Table: (Preferred Qualifications)Demonstrated ability to analyze complex issues and situations: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.Technical writing skills and proficiency in investigations and root cause analysis.Strong communication and presentation skills. Proficiency in English required.At Moderna, we believe that when you feel your best, you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work, at home, and everywhere in between.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavingsandinvestmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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 committed to equal opportunity in employment 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.Were 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 accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at leavesandaccommodations@modernatx.com .- #J-18808-Ljbffr