Scientist 1 - Product Characterization
Millipore Corporation

At MilliporeSigma, as the Scientist 1, you will be the primary scientific resource for a given study with the Product Characterization Laboratory within the overall Biologics department. The Scientist may act as subject matter expert in bioassay development for studies performed in the Product Characterization Lab and will oversee a wide variety of safety testing required to manufacture clinical and commercial products. You will be responsible for ensuring current regulatory requirements are met and the technical & regulatory needs of internal and external clients are appropriately met, effectively interpreted and then communicated to the client and performing analysis of testing performed within the Product Characterization Analytical Laboratory.

Responsibilities:

will include but are not limited to: Develops/validates and perform GMP methodsPerforms analysis and interpretation of dataPrepares/ reviews protocols and final reportsMay serve as study director and ensures timely initiation and completion of all studiesParticipates and/or drive assay development/ assay transfer and/or assay validation activitiesResponsible for resolving deviations/ completing event recordsLiaises with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testingResponsible for creating/revising SOPs, laboratory records and other related documentationContributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipmentProvides technical advice and support for internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences

Who You Are:

Minimum Qualifications:

Ph.D. in scientific discipline (i.e., Biology, Biochemistry, Chemistry etc.) with 1+ years of experience in a laboratory environment - OR -Master's degree in scientific discipline (i.e., Biology, Biochemistry, Chemistry, etc.) with 3+ years of experience in a laboratory environment - OR -Bachelor's degree in scientific discipline (i.e., Biology, Biochemistry, Chemistry etc.) with 5+ years of experience in a laboratory environment - OR -Associates degree in scientific discipline (i.e., Biology, Biochemistry, Chemistry etc.) with 7+ years of experience in a laboratory environment

Preferred Qualifications:

Working knowledge and experience in scientific discipline executing and overseeing technical projects and/or related studies Experience leading and/or supervising staff in a laboratory settingExperience with some or all of the following technical disciplinesELISA Cell-based bioassays Molecular qPCR and ddPCRFlow Cytometry (potency, titer, viability or identity)Western blots