• Job Description

  Req#: R15404

  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 solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.

  We are seeking a highly motivated and experienced Senior Manager Stability CMOs to join our dynamic team in Basel. This pivotal role involves managing direct reports and routine operations of the Drug product and Drug substance CMOs for Commercial GMP stability programs, ensuring compliance with SOPs, policies, and industry guidance. You will be instrumental in leading, facilitating, and supporting global processes for the harmonization and integration of stability-related activities, owning and supporting various GMP Quality Systems.

  Here’s What You’ll Do:

  Your key responsibilities will be:

  • Leadership and Management: You will manage, lead, and support the training of direct reports, set department goals, and compile/communicate performance reviews. Your leadership will inspire the team to foster an environment focused on continuous improvement activities for commercial stability programs.

  • Process Harmonization and Integration: Taking charge of processes for harmonization and integration of stability-related activities, including SOPs, stability protocols, and data integration among sites for global stability products, will be crucial. You will author, review, revise, and approve these documents, ensuring global compliance and consistency.

  • Collaboration and Strategy: Leading, facilitating, and executing stability study protocol strategy and design through direct collaboration with CMO stability specialists. This includes authoring and reviewing supporting memos and reports for expiry, interim/final stability reports, and Annual Product Quality Reports.

  Your responsibilities will also include:

  • Quality Systems Management: You will manage, lead, and own Quality Systems (eQMS) records for QC Stability—creating, assessing, reviewing, and approving deviations, change controls, CAPAs, and other applicable stability-related investigations and events.

  • Audit and Inspection Readiness: Leading and supporting site inspection readiness and audit activities, ensuring the functionality and maintenance of stability-related processes and systems at CMOs.

  • Regulatory Submissions and Coordination: You'll be responsible for authoring and reviewing applicable stability sections of regulatory submissions and coordinating with appropriate lab management teams to ensure the scheduling of stability sample submission, testing, and reporting of data.

  • Stability Metrics and Communication: Facilitating, leading, and supporting all activities for stability team meetings and reporting and communicating stability metrics to the Stability committee and key stakeholders in a timely manner.

  • Statistical Analysis and Compliance: Supporting statistical analysis activities for shelf-life, managing stability schedules for GMP stability drug substance and drug product, and ensuring compliance with cGMP and safety requirements.

  The key Moderna Mindsets you’ll need to succeed in the role:

  • Act with urgency: This role requires immediate and effective action to impact the lives saved tomorrow.

  • Pursue options in parallel: You will need to evaluate multiple strategies simultaneously to make the best decisions for stability programs.

  Here’s What You’ll Bring to the Table:

  • Bachelor’s degree in relevant scientific discipline with a minimum of 8-10 years Quality Control experience in a Commercial/ Quality Assurance/ Quality Control Biotech or Pharma setting with a focus on Stability (preferable in life science or equivalent), including regulatory submissions. Fluent in written and spoken English.

  • Deep understanding and experience with EU, US and ICH guidelines and regulations.

  • Experience in managing stability programs and with stability data trending analysis.

  • Minimum of 2-4 years or more of leadership/management experience including involvement with regulatory audits and inspections.

  • General experience in data analysis and statistical evaluation and trending of data.

  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.

  • Ability to interact effectively with all levels of personnel within the organization and externally with CTOs and CMOs. Ability to navigate through ambiguity and rapid growth and adapt to change.

  • Proven ability to lead and manage projects of significant scope and complexity, meeting deliverables and timelines.

  • Ability to travel up to 20% of the time.

  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:

  • 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!

  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.

  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 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. 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 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.

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• 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.

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