The Role:\
This is a newly created role in the Manufacturing Science and Technology (MST) department to support Moderna\\xe2\\x80\\x99s Contract Manufacturing Organization (CMO) activities in Europe for drug substance manufacturing. The individual will work closely with CMOs to ensure that all aspects of technology transfer and technical support are successfully executed. The individual also must establish strong relationships with Moderna\\xe2\\x80\\x99s internal departments: Manufacturing, Supply Chain, Regulatory, and Quality Teams. \
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The individual will support tech transfer, process validation activities and life cycle CMC activities, including protocol generation, oversight of CMO execution and summary report generation as well as ensuring continued process verification for Moderna products. \
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\Here\\xe2\\x80\\x99s What You\\xe2\\x80\\x99ll Do:\
Support technology transfer activities for clinical/commercial products into CMOs. \
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Provide technical support of cGMP manufacturing at CMOs including authoring of technology transfer documents, supporting change controls, closing manufacturing investigations, and helping validation actives. \
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Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Establish and maintain data repositories. \
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Lead cross functional troubleshooting and operational improvements for manufacturing process and equipment. \
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Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing. \
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Maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions. \
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\Here\\xe2\\x80\\x99s What You\\xe2\\x80\\x99ll Bring to the Table:\
M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.) \
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A minimum of 5 years related work experience \
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Process development or operational experience in one or more of the following bioprocessing unit operations: Enzymatic reaction, chromatography, tangential flow filtration, buffer formulation, drug product formulation, and aseptic filling. \
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Experience in providing technical support to cGMP manufacturing organization \
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Experience in working with Single-Use equipment \
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Experience in supporting tech transfer, change control, investigation, and data analysis. \
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Outstanding communication skills in English (verbal and written, basic knowledge of German is favorable). \
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Ability to manage projects in a fast-paced environment. \
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Ability to effectively collaborate in a dynamic, cross-functional matrix environment. \
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Ability to adapt to new and challenging technical opportunities. \
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Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. \
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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 winter break \
Educational resources \
Savings and investments \
Location-specific perks and extras! \
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The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. \
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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. \
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Moderna\\\'s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com . \
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Moderna is a smoke-free, alcohol-free and drug-free work environment. \
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