Scientist 1 - Product Characterization

BioReliance Corporation•Rockville, MD

14h•Onsite

About The Position

At MilliporeSigma, as the Scientist 1, your activities will support assay development through commercial application of new and innovative service offerings within the biosafety testing space. You are responsible for the scientific integrity of technical work performed in the laboratory, and are required to make scientific observations, maintain detailed workbooks/documentation and ensure all documentation fulfills generally accepted professional/industry standards. Requirements also include maintaining a thorough understanding of company testing services, technical principles and applications as they apply to your position. Act as subject matter expert (SME) for specific defined area(s) of BioReliance business. For GLP studies, acts as Study Director. Fully responsible for the technical conduct of a GMP/GLP study, as well as for the interpretation, analysis, documentation, and reporting of results. Assure that appropriate technical specifications and standard operating procedures are followed. Assure that all experimental data, including observations of unanticipated test system responses are accurately recorded and reviewed. Assure that computerized systems used in the study have been validated or are under appropriate controls. Utilizes problem solving/ trouble shooting skills. Leads the completion of deviation investigation records in a timely manner. Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing. Maintains a working knowledge of lab procedures and assays. Creates/ revises SOPs, laboratory records and other related documentation as assigned. Writes technical reports for internal use and collaborates on papers for external use. Performs training of laboratory personnel as needed/ assigned. Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment. Acts as key driver/ champion on project teams. Complies with company health and safety regulations and procedures.

Requirements

Ph.D. in scientific discipline (Immunology, Chemistry, Biology, etc. ) with 1+ years of experience in a laboratory environment
Master’s degree in scientific discipline (i.e., Immunology, Chemistry, Biology, etc) with 3+ years of experience in a laboratory environment
Bachelor’s degree in scientific discipline (i.e., Immunology, Chemistry, Biology, etc) with 5+ years of experience in a laboratory environment

Nice To Haves

PhD in Immunology
Extensive hands-on experience with Flow Cytometry/cell sorting techniques (potency, titer, viability or identity)
Hands-on experience with Mammalian cell-based Immunoassays (preferred cell line, adherent cells e.g. HEK293; suspension T cell (SupT1, MT4, H9) and primary hematopoietic cells (CD34+ cells))
Hands-on experience with Quantitative ELISA (Relative potency, titer, host cell protein, etc.)
Experience with industry GxP compliance
Intermediate skills in applicable computer programs (Softmax, PLA, or FACSDiva)
Hand-on experience with equipment (FACSCanto, Cell sorters, Cell counter, Stemvision, automatic liquid handler, etc.)
Excellent verbal and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.
Excellent time management skills
Highly collaborative as well as independent
Excellent multi-tasking abilities
Demonstrates a high level of initiative and leadership capabilities.
Effective coaching and training skills for complex and highly technical work
Highly, technically competent

Responsibilities

Act as subject matter expert (SME) for specific defined area(s) of BioReliance business.
For GLP studies, acts as Study Director.
Fully responsible for the technical conduct of a GMP/GLP study, as well as for the interpretation, analysis, documentation, and reporting of results.
Assure that appropriate technical specifications and standard operating procedures are followed.
Assure that all experimental data, including observations of unanticipated test system responses are accurately recorded and reviewed.
Assure that computerized systems used in the study have been validated or are under appropriate controls.
Utilizes problem solving/ trouble shooting skills.
Leads the completion of deviation investigation records in a timely manner.
Liaise with Quality Assurance and appropriate cross-functional departmental areas to close the events and corrective actions identified during GxP laboratory testing.
Maintains a working knowledge of lab procedures and assays.
Creates/ revises SOPs, laboratory records and other related documentation as assigned.
Writes technical reports for internal use and collaborates on papers for external use.
Performs training of laboratory personnel as needed/ assigned.
Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment.
Acts as key driver/ champion on project teams.
Complies with company health and safety regulations and procedures.