MSD
Principal Scientist, Sterile Drug Product Commercialization
MSD, West Point, Nebraska, United States, 68788
Job Description
Principal Scientist, Sterile Drug Product Commercialization
As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. It is the division’s leader in sterile product and process development, responsible for late-stage 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. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel vaccines, biologics, and pharmaceutical products and combination products.
We are seeking an experienced Principal Scientist to advance and commercialize a live virus vaccine (LVV) pipeline program. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process scale up, transfer and process validation activities at the manufacturing site.
What you will do:
Execute and provide oversight to LVV product and process design, development, characterization, technology transfer, and robust commercial validation.
Serve on cross functional drug product (DP) working group and support LVV lyophilized DP activities through filing and Process Performance Qualification (PPQ), site characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
Ensure commercialization program meets requirements related to science, quality, reliability, schedule, and cost.
Provide mentorship, technical oversight, and strategic guidance with respect to LVV process optimization. Use advanced experience gained on scientific/technical issues to guide others to address complex technical challenges.
Develop a process and product development plan. Influence decisions related to primary packaging and combination product design.
Innovate and drive best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Include the classification of process parameters, performance parameters, operating ranges, in-process controls. Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
Influence CMC regulatory strategy and author DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparation for agency meetings. Author and review regulatory submissions.
Create the best and next practices in LVV process scale down, parameter finding, site characterization and transfer.
Establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Qualifications:
Education:
B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience.
Preferred Experience and Skills:
Vaccine background including comprehensive knowledge and hands-on experience in live virus vaccines.
Working knowledge in cell-based assays for live-virus vaccines such as reporter gene assays, TCID50, plaque, and infectivity.
Experience with the manufacturing of sterile drug products (vaccines, biologics) at the pilot or commercial scale.
Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations. Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Experience in LVV drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles.
Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes.
Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).
Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.
This position may require travel up to 25-50%; must be able to travel for this position.
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Principal Scientist, Sterile Drug Product Commercialization
As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. It is the division’s leader in sterile product and process development, responsible for late-stage 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. The group is responsible for establishing the science, engineering and knowledge required for today’s innovative and accelerated commercialization of novel vaccines, biologics, and pharmaceutical products and combination products.
We are seeking an experienced Principal Scientist to advance and commercialize a live virus vaccine (LVV) pipeline program. As a member of the drug product team, the Principal Scientist will have a key focus on driving excellence in process scale up, transfer and process validation activities at the manufacturing site.
What you will do:
Execute and provide oversight to LVV product and process design, development, characterization, technology transfer, and robust commercial validation.
Serve on cross functional drug product (DP) working group and support LVV lyophilized DP activities through filing and Process Performance Qualification (PPQ), site characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
Ensure commercialization program meets requirements related to science, quality, reliability, schedule, and cost.
Provide mentorship, technical oversight, and strategic guidance with respect to LVV process optimization. Use advanced experience gained on scientific/technical issues to guide others to address complex technical challenges.
Develop a process and product development plan. Influence decisions related to primary packaging and combination product design.
Innovate and drive best practices for commercial site tech transfer, facility fit and development of the DP control strategy. Include the classification of process parameters, performance parameters, operating ranges, in-process controls. Drive and influence process demonstration and qualification (PPQ) and shelf-life strategies.
Influence CMC regulatory strategy and author DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparation for agency meetings. Author and review regulatory submissions.
Create the best and next practices in LVV process scale down, parameter finding, site characterization and transfer.
Establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Qualifications:
Education:
B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience; or
Master's degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or
Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 8 years of relevant experience.
Preferred Experience and Skills:
Vaccine background including comprehensive knowledge and hands-on experience in live virus vaccines.
Working knowledge in cell-based assays for live-virus vaccines such as reporter gene assays, TCID50, plaque, and infectivity.
Experience with the manufacturing of sterile drug products (vaccines, biologics) at the pilot or commercial scale.
Working knowledge of cGMPs for manufacturing of sterile dosage forms and current ICH Quality norms as applied in Manufacturing Science and Technology or Technical Operations. Technical expertise in sterile drug product fill finish related manufacturing processes for large molecules, including laboratory and/or fundamental models for key unit operations.
Experience with technology transfer and scale-up of processes to pilot and/or manufacturing scales.
Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Experience in LVV drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles.
Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes.
Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).
Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.
This position may require travel up to 25-50%; must be able to travel for this position.
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