Director/Sr Director/Executive Director - MSAT - Dry Products Network
Scorpion Therapeutics, Indianapolis, Indiana, us, 46262
Role Summary
Director/Sr Director/Executive Director, MSAT - Dry Products Network provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. The role leads cross-functional initiatives to commercialize dry oral solid drug products, optimize manufacturing platforms, and ensure robust process design and regulatory alignment. Responsibilities
Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products. Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Achieve network level results for Lilly’s dry products that improve effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business by driving organizational improvement and capability work. Influence global leadership in driving improvements and resolving issues. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites and provide additional technical support/guidance for external manufacturing as needed. Drive shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches. Utilize understanding of materials, process, and product to improve robustness, reduce variability, and advance control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage experience as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in optimizing key manufacturing platforms such as continuous manufacturing. Influence Development on new product/platform topics in line with Manufacturing needs. Identify and lead deployment of new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality documents and support regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and related technical documentation. Provide input on experimental findings and conclusions as a reviewer of technical reports. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, and business approach and behaviors. Qualifications
Required: Bachelor’s or Master’s in Chemistry, Engineering, Pharmacy, or related science with minimum 15 years of direct experience in Dry products Manufacturing and Development/Commercialization. Required: Technical expertise in multiple areas, unit operations, and platforms related to technical support of dry products (oral solid dosage forms) commercial manufacturing as well as experience in development and commercialization of these dosage forms. Preferred: PhD in Chemistry, Engineering, Pharmacy, or related science with minimum 10 years of direct experience in Dry products Manufacturing and Development/Commercialization. Skills
Strong technical leadership and communication skills; ability to influence and drive cross-functional understanding and actions. Ability to work independently and in teams; effective partnership across disciplines. Strong analytical and problem-solving abilities; ability to integrate multiple technology disciplines to drive programs forward. Education
Bachelor’s or Master’s in Chemistry, Engineering, Pharmacy, or related science (required). PhD in Chemistry, Engineering, Pharmacy, or related science (preferred).
#J-18808-Ljbffr
Director/Sr Director/Executive Director, MSAT - Dry Products Network provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. The role leads cross-functional initiatives to commercialize dry oral solid drug products, optimize manufacturing platforms, and ensure robust process design and regulatory alignment. Responsibilities
Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products. Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Achieve network level results for Lilly’s dry products that improve effectiveness of TS/MS, Lilly Manufacturing, or other parts of the business by driving organizational improvement and capability work. Influence global leadership in driving improvements and resolving issues. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites and provide additional technical support/guidance for external manufacturing as needed. Drive shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches. Utilize understanding of materials, process, and product to improve robustness, reduce variability, and advance control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage experience as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in optimizing key manufacturing platforms such as continuous manufacturing. Influence Development on new product/platform topics in line with Manufacturing needs. Identify and lead deployment of new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality documents and support regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and related technical documentation. Provide input on experimental findings and conclusions as a reviewer of technical reports. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, and business approach and behaviors. Qualifications
Required: Bachelor’s or Master’s in Chemistry, Engineering, Pharmacy, or related science with minimum 15 years of direct experience in Dry products Manufacturing and Development/Commercialization. Required: Technical expertise in multiple areas, unit operations, and platforms related to technical support of dry products (oral solid dosage forms) commercial manufacturing as well as experience in development and commercialization of these dosage forms. Preferred: PhD in Chemistry, Engineering, Pharmacy, or related science with minimum 10 years of direct experience in Dry products Manufacturing and Development/Commercialization. Skills
Strong technical leadership and communication skills; ability to influence and drive cross-functional understanding and actions. Ability to work independently and in teams; effective partnership across disciplines. Strong analytical and problem-solving abilities; ability to integrate multiple technology disciplines to drive programs forward. Education
Bachelor’s or Master’s in Chemistry, Engineering, Pharmacy, or related science (required). PhD in Chemistry, Engineering, Pharmacy, or related science (preferred).
#J-18808-Ljbffr