Your role:

At MilliporeSigma the Scientist I, Research Solutions will support the SMC™ Single-plex Assay Development Team.  He/she will be working independently to develop immunoassays for use on MilliporeSigma SMC™ Immunoassay platform.  This is a high-visibility, hands-on bench laboratory position that includes designing and performing experiments, analyzing resultant data, writing reports, and presenting results to peers within MilliporeSigma, academic partners, or corporate partners.  Tasks will include, but are not limited to: assay feasibility, assay development, optimization, reagent formulation, guard band and stability studies, sample testing, verification and validation studies.  

Responsibilities:

• Follow established assay development standard operating procedures (SOPs) in a fast-paced, high-energy environment.
• Analysis of human specimens (serum, plasma, CSF, tissue lysates, etc.) for specific analytes using SMC™ or other immunoassay.
• Plan and execute experiments that support investigations into new biomarker assays, including understanding potential interfering proteins and sourcing appropriate antibodies & reagents. 
• Critically analyze, summarize and report data generated from experiments, draw conclusions from experimental results, recommend and execute follow-up actions with consideration of prior experimental findings (self and others) with minimal supervision.  Propose new investigations based on experimental findings. 
• Present data at Team meetings or to small focus groups that may include representatives from other departments and/or outside parties.  Participate in and may lead brainstorming and troubleshooting sessions.  May represent the Company in external relationships including communications with instrument manufacturers, suppliers of critical components, potential partners and evaluation sites.
• Facilitate the transfer of developed assays to Manufacturing, including involvement in the completion and release of enabling documentation for newly developed assays by ensuring all relevant technical information is incorporated into the appropriate documents.
• Maintain familiarity with current technology related information, literature and theories. Demonstrate scientific creativity and understanding of the principles, requirements and practices of immunoassay development.  Conduct project related information searches, literature searches, and may be involved in review for project specifications and initiation.  Contribute to scientific publications, posters and conferences, when appropriate

May have to work non-standard hours; for example, second shift, some weekends as needed to meet deadlines.

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in Microbiology, Immunology, Cell Biology, Biochemistry or other related Science Discipline with 3+ years’ experience with immunoassay development and assay validation for biomarker assays or bioanalytical analysis, with experience in at least one of the following assay formats: magnetic particle (e.g., MilliporeSigma Erenna® or Luminex platform), ECL, or ELISA or a Master’s degree in Microbiology, Immunology, Cell Biology, Biochemistry or other related Biological Sciences discipline.

Preferred Qualifications:

• PhD with 3+ years’ experience, Master’s degree with 7+ years’ experience or Bachelor’s degree with 10+ years’ industry experience in a regulated environment (In-Vitro Diagnostic (IVD) immunoassay development experience)
• Experience with RT-PCR
• Experience with Gate Review Product Development Process from Assay Development to Manufacturing/Operations desired
• Proven success in pre-clinical / clinical immunoassay development
• Demonstrated understanding of Oncology, Cardio & Metabolic Disease
• Working knowledge of statistics, Design of Experimentation (DOE), etc.
• Demonstrated proficiency with Excel, PowerPoint, and Word programs
• Excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical scientific information to a wide range of audiences
• Demonstrate technical proficiency, scientific creativity, collaboration with others and can work independently

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