Merck
Senior Principal Scientist, Upstream Process R&D
Merck, Rahway, New Jersey, United States, 07065
Senior Principal Scientist
Our Scientists are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology, we collaborate to deliver the next medical breakthroughs. We are looking for a collaborative, self-motivated scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist. BPR&D within Research Laboratories is committed to rapidly delivering diverse biotherapeutics to patients by efficiently developing innovative and robust manufacturing processes and technologies. To achieve our goals, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a diverse and inclusive environment. In addition to process development for pipeline biologics, we are focused on innovating and building next-generation biomanufacturing technologies. This includes investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field. As a Senior Principal Scientist, you will drive various strategic initiatives and translate strategies into implementation for Biologics platform. You will collaborate with an immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing technical strategies related to upstream processing and recombinant expression of drug candidates in early- and late-stage development. Responsibilities include, but are not limited to: Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy, and science. Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization. Improve upstream processes by increasing efficiency and cost-effectiveness through research and innovation, while evaluating technologies and industry best practices. Collaborate with academia, industry, and vendors to facilitate the development and early adoption of novel process technologies. Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution. Conceptualize, plan, and execute projects using effective organizational, prioritization, and problem-solving skills. Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference participation. Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams. Supervise, coach, and develop talent within the functional area; guide career development; build strong, collaborative teams. Champion compliance and safety while promoting a culture of diversity, equity, and inclusion. Minimum Education Requirements: Ph.D. with 10+ years, MS with 12+ years, or BS with 14+ years of industry experience in Chemical/Biochemical Engineering or a related field. Required Experience, Skills, and Competencies: Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactor scale-up and scale-down, as well as recent advances, and challenges in the field Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process development Track record of accomplishments in upstream bioprocessing with a history of peer-reviewed publications and presentations. Strong understanding of cell metabolism and biochemical pathways relevant to bioprocessing. Knowledge of biologics CMC development Ability to adapt to and prioritize complex objectives under tight timelines in a rapidly changing environment. Experience leading internal and external cross-functional, matrixed teams. Demonstrated scientific leadership with significant, measurable project impacts across a diverse set of programs. Action-oriented mindset with a capacity for creativity; ability to take initiative, innovate, iterate, and solve problems. Supervise, coach and mentor scientists to maximize talent development and utilization. Excellent interpersonal and communication skills. Preferred Experience & Skills: Leadership of CMC development teams. Experience with continuous biomanufacturing integrated with process-analytical technologies. Intensified inoculum and perfusion process development Expertise in media/solution development and chemistry High-throughput experimentation, automation, and process control. Knowledge of microbial fermentation Cell culture predictive modeling (omics (transcriptomics, metabolomics, or/and proteomics), metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence
Our Scientists are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology, we collaborate to deliver the next medical breakthroughs. We are looking for a collaborative, self-motivated scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist. BPR&D within Research Laboratories is committed to rapidly delivering diverse biotherapeutics to patients by efficiently developing innovative and robust manufacturing processes and technologies. To achieve our goals, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a diverse and inclusive environment. In addition to process development for pipeline biologics, we are focused on innovating and building next-generation biomanufacturing technologies. This includes investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field. As a Senior Principal Scientist, you will drive various strategic initiatives and translate strategies into implementation for Biologics platform. You will collaborate with an immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing technical strategies related to upstream processing and recombinant expression of drug candidates in early- and late-stage development. Responsibilities include, but are not limited to: Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy, and science. Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization. Improve upstream processes by increasing efficiency and cost-effectiveness through research and innovation, while evaluating technologies and industry best practices. Collaborate with academia, industry, and vendors to facilitate the development and early adoption of novel process technologies. Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution. Conceptualize, plan, and execute projects using effective organizational, prioritization, and problem-solving skills. Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference participation. Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams. Supervise, coach, and develop talent within the functional area; guide career development; build strong, collaborative teams. Champion compliance and safety while promoting a culture of diversity, equity, and inclusion. Minimum Education Requirements: Ph.D. with 10+ years, MS with 12+ years, or BS with 14+ years of industry experience in Chemical/Biochemical Engineering or a related field. Required Experience, Skills, and Competencies: Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactor scale-up and scale-down, as well as recent advances, and challenges in the field Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process development Track record of accomplishments in upstream bioprocessing with a history of peer-reviewed publications and presentations. Strong understanding of cell metabolism and biochemical pathways relevant to bioprocessing. Knowledge of biologics CMC development Ability to adapt to and prioritize complex objectives under tight timelines in a rapidly changing environment. Experience leading internal and external cross-functional, matrixed teams. Demonstrated scientific leadership with significant, measurable project impacts across a diverse set of programs. Action-oriented mindset with a capacity for creativity; ability to take initiative, innovate, iterate, and solve problems. Supervise, coach and mentor scientists to maximize talent development and utilization. Excellent interpersonal and communication skills. Preferred Experience & Skills: Leadership of CMC development teams. Experience with continuous biomanufacturing integrated with process-analytical technologies. Intensified inoculum and perfusion process development Expertise in media/solution development and chemistry High-throughput experimentation, automation, and process control. Knowledge of microbial fermentation Cell culture predictive modeling (omics (transcriptomics, metabolomics, or/and proteomics), metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence