Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

MilliporeSigma is expanding our Mirus Bio facility in Madison, WI! Mirus Bio pioneered the manufacture of transfection reagents and proprietary technologies for nucleic acid delivery applications. Our dynamic and forward-thinking approach has allowed us to stay agile and adapt to emerging trends. Our work is technical and cutting-edge, and we promote a culture that encourages creativity, initiative, responsibility, and respect. Mirus’ current focus is on developing and commercializing novel research and GMP-grade products to enable researchers within the cell and gene therapy space.
 

We have an immediate opening for a full-time Analytical Method Transfer and Validation Scientist to execute the technical transfer and support the validation of assays for the next generation of transfection reagents, enhancers, and related products. This role will join the Quality Team to support final stages of method development and technical transfer to internal QC team or external testing laboratories for validation as part of new product introduction or continuous improvement projects. 

Project Core Team member responsible for the on-time execution of the analytical assay deliverables per the Project Plan and responsible for collaboration with the Project Manager and Project Core TeamResponsible for the scoping and project plan development for the analytical assays.  Accountable for technical transfer and method validation project oversight and timeline management with internal and external partnersAct as the primary point of contact and subject matter expert (SME) to enable the technical transfer of analytical methods to internal and external partners; help write, and review SOPs related to analytical instrumentation and associated methodsProvide analytical expertise to help support development and transfer analytical methods for qualification/validation. This includes the characterization, purity, identity, and stability of Mirus product formulations using various techniques, such as ultra/high performance liquid chromatography (U/HPLC), nuclear magnetic resonance spectroscopy (NMR), fourier-transform infra-red (FTIR) spectroscopy, gel permeation chromatography (GPC)Evaluate and troubleshoot potential method issues through technical transfer process to ensure project success and prevent unnecessary timeline delaysCommunicate data, timelines and any technical issues from external partners to internal stakeholder through formal and informal platformsReview, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, and Good Manufacturing Practices (GMP)Ensure the method meets regulatory requirements and that method validation studies are performed according to ICH guidelinesPerform thorough data analysis, including statistical calculations, to interpret results and draw conclusions. Author project-related technical documents as required, such as validation protocols and reports, justification documents, deviations, and investigationsCommunicate effectively across multiple teams, such as R&D, Operations and Product Management, to ensure alignment, eliminate barriers and support project timelinesBuild positive relationships during internal and external interactionsPerform other duties as assigned by Senior Quality ManagerAs time permits, assist quality control department in troubleshooting instrument and analytical method investigations and method improvementsTravel independently up to 10%, including overnight travel

 

Who You Are :

 

Minimum Qualifications:

Bachelor’s Degree in Chemistry, Biology, or other Life Science discipline5+ years of work experience in life science manufacturing

OR

Master’s Degree in Chemistry, Biology, or other Life Science discipline

Preferred Qualifications:

Experience as a project team member executing work against complex project plansExperience working with external partners, contract test labs, commercial manufacturing and development organization, or similarStrong understanding of analytical principles and techniques (e.g. HPLC, GC, UV-Vis, etc.)Experience with method development and validation procedures, including regulatory guidelines (ICH Q2)Experience developing, performing, maintaining, and documenting various analytical techniques in an industrial setting under GxP guidelines and regulationsWork independently and collaboratively in a multi-disciplinary & team-oriented environmentWork in an organized manner, manage multiple priorities, make critical observations, and maintain records of the resultsProficiency with Microsoft Office including Excel, Word and PowerPoint

 

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html