Senior Associate Scientist Product Characterization

Company: Millipore Corporation
Location: Rockville
Posted on: October 15, 2020

Job Description:

Your Role: The Senior Associate Scientist will oversee a wide variety of safety testing required to manufacture clinical and commercial products. The Scientist will be the primary scientific resource for a given study with the Product Characterization lab within the overall Biologics department. The Senior Associate Scientist is responsible for making observations and ensuring all documentation is in compliance with procedures and regulations. Perform analysis of testing performed within the Product Characterization Laboratory. May act as subject matter expert in bioassay development for studies performed in the Product Characterization laboratory. Will develop/validate and perform GMP methods. - Provides day to day technical support to the laboratory. - Performs analysis and interpretation of data. - Prepares/ reviews protocols and final reports. - May serve as study director and ensures timely initiation and completion of all studies. - Ensures testing is performed in accordance with SOPs and regulations (cGMP and GLP) for custom/non routine and new services. - Participate and/or drive assay development/ assay transfer and/or assay validation activities. - Justify business needs and drive implementation of new services. - Operates and maintains lab equipment as required by SOPs and testing procedures. - Responsible for resolving deviations/ completing event records. - Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing. - Maintains high level knowledge of lab procedures and assays. - Responsible for creating revising SOPs, laboratory records and other related documentation. - Coaches/ trains others on developing and enhancing day to day laboratory techniques. - Contributes ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment. - Regarded as a subject matter expert (SME) - Provide technical advice and support for internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences. - Promote a culture of continuous improvement within Biologics; act as champion on initiatives and/or projects to drive improvement in quality and / or client service. Contributes/ authors scientific publications and presents at conferences/ seminars. Leads projects that cross multiple disciplines. - Complies with company health and safety regulations and procedures. - Performs other duties as assigned Who You Are: Minimum Requirements: - Ph.D. in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 1+ years working laboratory experience - OR - - Master's degree in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 2+ years working laboratory experience - OR - - Bachelor's degree in scientific discipline (i.e. Chemistry, Biochemistry, etc.) with 5+ years working laboratory experience Preferred Requirements: - Relevant working knowledge and Experience with development of assays with some or all the following technical disciplines; - Flow Cytometry - Host Cell Protein ELISA - ELISA - Cell based assay experience - SPR Platforms - Developing and validating assays in GMP environment - Usage of following software/equipment: - SoftMax Pro - BD Facs Diva - Cytiva/GE Biacore (T200/8K system) - Usage of automated cell counter RSRMS Recommended skills Documentation Biochemical Assays Certified Global Meeting Planner Good Manufacturing Practices Chemistry Quality Assurance

Keywords: Millipore Corporation, Rockville , Senior Associate Scientist Product Characterization, Other , Rockville, Maryland