MSD Malaysia
Principal Scientist, Biophysical Characterization
MSD Malaysia, Rahway, New Jersey, us, 07065
Principal Scientist, Biophysical Characterization
Job Description Principal Scientist Job Description The Materials and Biophysical Characterization group in Analytical Research and Development is seeking a highly self-motivated and innovative scientist with deep knowledge and problem-solving skills in biotherapeutics characterization with a proven track record. The Biophysical Characterization team is responsible for building the mechanistic understanding of the interplay between formulation composition, process and stability of drug substance and drug product to ensure robustness, as well as interrogating the higher order structure of biotherapeutics. As part of the CMC development team, you will be leading and/or supporting projects in the diverse pipeline by developing and implementing biophysical and particle characterization tools for biotherapeutic drug products as well as mentoring other team members in delivering results collaborating with process, formulation and device. You are expected to use your scientific expertise to find ingenious and creative solutions to challenging problems which require deep analytical insight and critical thinking. Additional responsibilities include authoring technical reports and regulatory documents, presenting technical data, and project management. You will serve as a senior scientific leader and provide scientific mentorship to members of our research team. You will conduct and lead independent research, publish research findings, present at scientific conferences, and engage with various external scientific societies/organizations. This is an excellent growth and learning opportunity to work in an exciting, collaborative environment with a wide array of scientists from different divisions, and make significant contributions towards our life-saving medicines. Education Minimum Requirement: Ph.D. in Biophysics, Biochemistry, Biomedical/Chemical Engineering, Pharmaceutical Sciences or related discipline with >8 years’ of industry related experience. Master’s degree in Biophysics, Biochemistry, Biomedical/Chemical Engineering, Pharmaceutical Sciences or related discipline with >12 years’ of industry related experience. Required Experience and Skills: Fundamental understanding of protein science, protein/peptide stability, and protein-protein interactions and demonstrate understanding of connectivity between the functions supporting the pipeline (i.e. quality, regulatory, clinical development; chemistry, manufacturing, and control (CMC); supply chain, and human health). Track-record of independent problem-solving applying deep technical and subject matter expertise and understanding of new product development and commercialization. Hands-on experience with biophysical and particle characterization techniques for biotherapeutics characterization, excellent analytical skills and the ability to analyze and interpret complex data sets. Self-motivated with an outstanding scientific track-record; able to apply new findings to address project challenges and encourage others to explore alternative ways to view and solve problems in innovative ways to achieve results. Excellent interpersonal and communication skills, actively engages in two-way communication to build trusting relationships. Desire and willingness to mentor, learn and contribute, actively build the best team providing timely feedback and coaching to talent within organizations. Excellent organizational skills to multi-task and manage multiple projects. Ability to drive operational excellence by clarifying and translating priorities into actionable steps, and monitor the progress of the individual or team to ensure deliverables are met aligned with agreed standards and methodologies. Desired Experience and Skills: Strong background in chemistry/biochemistry with application in biotherapeutics characterization. Experience in working in multi-disciplinary project teams as a lead. Experience/knowledge in BioNMR and Mass spec. Experience/knowledge in formulation development and relevant analytical assay development. Experience with various modalities including peptides, mAbs, ADC, gene therapy, engineered cellular therapies.
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Job Description Principal Scientist Job Description The Materials and Biophysical Characterization group in Analytical Research and Development is seeking a highly self-motivated and innovative scientist with deep knowledge and problem-solving skills in biotherapeutics characterization with a proven track record. The Biophysical Characterization team is responsible for building the mechanistic understanding of the interplay between formulation composition, process and stability of drug substance and drug product to ensure robustness, as well as interrogating the higher order structure of biotherapeutics. As part of the CMC development team, you will be leading and/or supporting projects in the diverse pipeline by developing and implementing biophysical and particle characterization tools for biotherapeutic drug products as well as mentoring other team members in delivering results collaborating with process, formulation and device. You are expected to use your scientific expertise to find ingenious and creative solutions to challenging problems which require deep analytical insight and critical thinking. Additional responsibilities include authoring technical reports and regulatory documents, presenting technical data, and project management. You will serve as a senior scientific leader and provide scientific mentorship to members of our research team. You will conduct and lead independent research, publish research findings, present at scientific conferences, and engage with various external scientific societies/organizations. This is an excellent growth and learning opportunity to work in an exciting, collaborative environment with a wide array of scientists from different divisions, and make significant contributions towards our life-saving medicines. Education Minimum Requirement: Ph.D. in Biophysics, Biochemistry, Biomedical/Chemical Engineering, Pharmaceutical Sciences or related discipline with >8 years’ of industry related experience. Master’s degree in Biophysics, Biochemistry, Biomedical/Chemical Engineering, Pharmaceutical Sciences or related discipline with >12 years’ of industry related experience. Required Experience and Skills: Fundamental understanding of protein science, protein/peptide stability, and protein-protein interactions and demonstrate understanding of connectivity between the functions supporting the pipeline (i.e. quality, regulatory, clinical development; chemistry, manufacturing, and control (CMC); supply chain, and human health). Track-record of independent problem-solving applying deep technical and subject matter expertise and understanding of new product development and commercialization. Hands-on experience with biophysical and particle characterization techniques for biotherapeutics characterization, excellent analytical skills and the ability to analyze and interpret complex data sets. Self-motivated with an outstanding scientific track-record; able to apply new findings to address project challenges and encourage others to explore alternative ways to view and solve problems in innovative ways to achieve results. Excellent interpersonal and communication skills, actively engages in two-way communication to build trusting relationships. Desire and willingness to mentor, learn and contribute, actively build the best team providing timely feedback and coaching to talent within organizations. Excellent organizational skills to multi-task and manage multiple projects. Ability to drive operational excellence by clarifying and translating priorities into actionable steps, and monitor the progress of the individual or team to ensure deliverables are met aligned with agreed standards and methodologies. Desired Experience and Skills: Strong background in chemistry/biochemistry with application in biotherapeutics characterization. Experience in working in multi-disciplinary project teams as a lead. Experience/knowledge in BioNMR and Mass spec. Experience/knowledge in formulation development and relevant analytical assay development. Experience with various modalities including peptides, mAbs, ADC, gene therapy, engineered cellular therapies.
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