Merck
Principal Scientist
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Biologics Analytical Research & Development department of our Company's Research & Development Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics pipeline. We are looking for a team player with strong leadership skills and the passion for mentoring and working along others in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral. A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected. Qualifications Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 16 years of experience in the pharmaceutical industry. Required Experience and Skills Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills. Demonstrated ability for taking initiative, creativity, and innovation in problem solving Background in Analytical Methodologies (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. Extensive experience with bioprocess derived impurities, particularly residual host cell proteins (rHCPs) assay development, qualification, implementation, troubleshooting and transfer using immunoassay techniques. Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in biologics. A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines. Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications. Experience with matrix management and peer to peer coaching. Accurately and efficiently documentation of experiments. Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. Preferred Experience and Skills Knowledge or experience with 2D-SDS-PAGE, 2D-DIGE, or 2D-DIBE technologies for HCP antibody reagents characterization. Knowledge or experience with polyclonal antibody purification from animal antisera and antibody conjugation techniques. Familiar with different types of immunoassay such as ELISA, Western blot, and knowledge of different technology platforms for quantitative and semi-quantitative determination of protein analyte using immunoassay principles. Knowledge of benchmarking HCP profiling and quantification technologies including proteomics and the use of proteomic LC-MS for protein profile comparison. Knowledge of using statistics in data analysis and familiar with using statistical software for design of experiments. Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP Excellent track record in scientific publications, patents, or conference presentations.
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Biologics Analytical Research & Development department of our Company's Research & Development Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics pipeline. We are looking for a team player with strong leadership skills and the passion for mentoring and working along others in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral. A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected. Qualifications Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 16 years of experience in the pharmaceutical industry. Required Experience and Skills Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills. Demonstrated ability for taking initiative, creativity, and innovation in problem solving Background in Analytical Methodologies (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. Extensive experience with bioprocess derived impurities, particularly residual host cell proteins (rHCPs) assay development, qualification, implementation, troubleshooting and transfer using immunoassay techniques. Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in biologics. A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines. Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications. Experience with matrix management and peer to peer coaching. Accurately and efficiently documentation of experiments. Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. Preferred Experience and Skills Knowledge or experience with 2D-SDS-PAGE, 2D-DIGE, or 2D-DIBE technologies for HCP antibody reagents characterization. Knowledge or experience with polyclonal antibody purification from animal antisera and antibody conjugation techniques. Familiar with different types of immunoassay such as ELISA, Western blot, and knowledge of different technology platforms for quantitative and semi-quantitative determination of protein analyte using immunoassay principles. Knowledge of benchmarking HCP profiling and quantification technologies including proteomics and the use of proteomic LC-MS for protein profile comparison. Knowledge of using statistics in data analysis and familiar with using statistical software for design of experiments. Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP Excellent track record in scientific publications, patents, or conference presentations.