MSD Malaysia
Associate Principal Scientist, Engineering
MSD Malaysia, Oregon, Illinois, United States, 61061
Associate Principal Scientist, Engineering
Job DescriptionPosition Description:As part of our Company’s Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point PA, USA with a presence in Carlow, Ireland supporting Irish and European Sterile Drug Product manufacturing sites.The SDPC group is the division’s leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.We are seeking an Associate Principal Scientist who is an experienced drug product commercialization scientist/engineer, to advance and commercialize Innovative Large Molecules to clinical and commercial manufacturing sites. This person would be accountable for the planning and execution of activities associated with commercial design, characterization and technology transfer.This specific role is targeted to support vaccine drug product development and will report through the vaccines lead within SDPC. The role is targeting an individual that could be tasked to lead the drug product team tasked to deliver a new product.This position may require travel up to 25%. Must be able to travel for this position.Accountabilities and Responsibilities for this position include but are not limited to the following:SDPC Drug Product Working Group Lead or Team Member
Responsible for the commercialization of a sterile drug product large molecule.Provides technical guidance and oversight of late-stage product and process characterization.Manages DP activities through filing and Process Performance Qualification (PPQ), including registration of stability study execution, process characterization plan and execution, technology transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.Responsible for commercial site technology transfer and facility fit.Provides a regular summary of progress against development plan, key program and technical risks and risk level, mitigation strategies, and how success will be determined.
Product development and characterization
Develops a process and product characterization plan.Responsible for the design and execution of DP characterization and commercialization studies, new product introduction and process validation at commercial sites.Develops a robust and scalable manufacturing processes while minimizing time to regulatory filing and product launch.Drives the design and execution of process characterization activities. Ensures fit-for-purpose scale-down models are developed and employed. Oversees lab studies, as required, to ensure ‘right first time’.Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and challenging issues.Responsible for the DP control strategy, including the recommendation of process parameters, performance parameters, operating ranges, in-process controls and parameter classification.Establishes and validates platform engineering and scientific models for sterile product and process commercialization.Ensures commercialization programs meet requirements related to science, quality, reliability, schedule and cost. Monitors performance and recommends schedule changes, cost adjustments or resource additions.Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy (including filing storyboard) and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory filings.
Continuous improvement
Serves on cross functional teams and support strategic initiatives.Leads agile implementation of new/improved business processes in partnership with colleagues in Research Laboratories and the Manufacturing Division.Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
Team Leadership
Provides mentorship, technical oversight and strategic guidance to employees.Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.Manages a small group of individual contributors.
Position Qualifications:Minimum Education Requirements and Experience:Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience;
ORMaster of Science (M.S.) degree in chemical engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of relevant experience;
ORPh.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with three (3) years of relevant experience.Preferred Experience and Skills:Experience with vaccine drug product commercialization or manufacturing, with a particular focus on experience in adjuvanted vaccines.Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.Experienced in sterile drug product fill finish manufacturing practices.Knowledge or experience with single use system technologies.Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.Experience with utilization of QbD principles to process development and life cycle management.Experience in Design of Experiment (DoE) and statistical data analysis.Experience in Data Analytics.Experience in authoring and reviewing CMC regulatory documentation.Analytical problem-solving skills and competency in technical writing.Project management and activities management skills (dashboards, activity trackers).Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
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Job DescriptionPosition Description:As part of our Company’s Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point PA, USA with a presence in Carlow, Ireland supporting Irish and European Sterile Drug Product manufacturing sites.The SDPC group is the division’s leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.We are seeking an Associate Principal Scientist who is an experienced drug product commercialization scientist/engineer, to advance and commercialize Innovative Large Molecules to clinical and commercial manufacturing sites. This person would be accountable for the planning and execution of activities associated with commercial design, characterization and technology transfer.This specific role is targeted to support vaccine drug product development and will report through the vaccines lead within SDPC. The role is targeting an individual that could be tasked to lead the drug product team tasked to deliver a new product.This position may require travel up to 25%. Must be able to travel for this position.Accountabilities and Responsibilities for this position include but are not limited to the following:SDPC Drug Product Working Group Lead or Team Member
Responsible for the commercialization of a sterile drug product large molecule.Provides technical guidance and oversight of late-stage product and process characterization.Manages DP activities through filing and Process Performance Qualification (PPQ), including registration of stability study execution, process characterization plan and execution, technology transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.Responsible for commercial site technology transfer and facility fit.Provides a regular summary of progress against development plan, key program and technical risks and risk level, mitigation strategies, and how success will be determined.
Product development and characterization
Develops a process and product characterization plan.Responsible for the design and execution of DP characterization and commercialization studies, new product introduction and process validation at commercial sites.Develops a robust and scalable manufacturing processes while minimizing time to regulatory filing and product launch.Drives the design and execution of process characterization activities. Ensures fit-for-purpose scale-down models are developed and employed. Oversees lab studies, as required, to ensure ‘right first time’.Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and challenging issues.Responsible for the DP control strategy, including the recommendation of process parameters, performance parameters, operating ranges, in-process controls and parameter classification.Establishes and validates platform engineering and scientific models for sterile product and process commercialization.Ensures commercialization programs meet requirements related to science, quality, reliability, schedule and cost. Monitors performance and recommends schedule changes, cost adjustments or resource additions.Influences CMC regulatory strategy and is accountable for DP CMC sections of filing. Reviews regulatory strategy (including filing storyboard) and filing readiness and supports preparations for agency meetings. Authors and reviews regulatory filings.
Continuous improvement
Serves on cross functional teams and support strategic initiatives.Leads agile implementation of new/improved business processes in partnership with colleagues in Research Laboratories and the Manufacturing Division.Drives continuous and phase appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination product presentations.
Team Leadership
Provides mentorship, technical oversight and strategic guidance to employees.Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.Manages a small group of individual contributors.
Position Qualifications:Minimum Education Requirements and Experience:Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with eight (8) years of relevant experience;
ORMaster of Science (M.S.) degree in chemical engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of relevant experience;
ORPh.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with three (3) years of relevant experience.Preferred Experience and Skills:Experience with vaccine drug product commercialization or manufacturing, with a particular focus on experience in adjuvanted vaccines.Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.Experienced in sterile drug product fill finish manufacturing practices.Knowledge or experience with single use system technologies.Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.Experience with utilization of QbD principles to process development and life cycle management.Experience in Design of Experiment (DoE) and statistical data analysis.Experience in Data Analytics.Experience in authoring and reviewing CMC regulatory documentation.Analytical problem-solving skills and competency in technical writing.Project management and activities management skills (dashboards, activity trackers).Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
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