The Role: This is a newly created role in the international fill and finish operations department to support Moderna's Contract Manufacturing Organization (CMO) activities in Spain. As Manager, you will be part of Moderna's energized International Fill and Finish team and will focus on Drug Product Operations. You are responsible for supporting DP CMO operation internationally. The role will develop strong process oversight and governance mechanisms for various work streams as we evolve into the post-COVID era, continue to advance Moderna's pipeline products at DP CMOs. The Manager will develop timelines and governance, lead cross-functional project teams, support the CMO in project planning and execution, and coordinate the execution of tech transfer and manufacturing activities to meet submission timelines and fulfill market supply commitments. Mid to Long Term, the role will support and oversee production and supply harmonization between the different DP CMOs.
Here's What You'll Do:
Represent Moderna in the interface with DP CMOs and ensure robust manufacturing operation.Manage a visual metric/dashboard to provide oversight of the production plan, CMO efficiency and performance monitoring, OTIF and other operation KPIs.Create and maintain detailed project plans to ensure clarity of deliverables and timing.Track project tasks and ensure project timeline and deliverable adherence.Facilitate close collaboration, interactions, and alignment between Moderna and CMOs.Support and perform the reviews of production performance, KPIs, CPV at CMOs.Drive / lead continuous improvements at FF CMOs.In collaboration with Quality, coordinate investigations and troubleshooting efforts at FF CMOs.Write/revise/coordinate the review of GMP documentation to support production activities.Frequently visit and maintain presence at the external partners' sites and build strong interdependent relationships with the CMO counterparts to assess the as-is state & risks for action-oriented improvement plans. Here's What You'll Bring to the Table:
Education: University degree in an appropriate discipline (e.g., sciences, engineering).
Experience: 5+ years in Pharmaceutical/Biotechnology GMP environment, including CMOs. Experience in commercial scale cGMP operation, deviation handling, GMP change control, and familiarity with aseptic injectable products (vials, PFS).
Plus: Expertise in one or more of the following areas: Tech transfer, Aseptic processing/filling technology, cleaning validation, sterile filtration, visual inspection, labeling, packaging, and cold chain management.
Plus: Understanding of SAP ERP system, serialization, and aggregation requirements. Ability to work in a fluid environment and foster a strong collaborative spirit. Ability to negotiate and sustain networking relationships. Persuasive. Can-do attitude with a balanced risk-quality mindset. Strong analytical mindset, inquisitive and pragmatic. Strong knowledge of project management tools/software and digital solutions. Strong proficiency in English and Spanish is an added advantage. Strong communication, presentation, and report writing skills.
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: In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna is a smoke-free, alcohol-free, and drug-free work environment.
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