BioSpace
Sr Principal Scientist - Global Technical Services Molecule Steward - Dry Produc
BioSpace, Indianapolis, Indiana, us, 46262
Overview
Sr Principal Scientist - Global Technical Services Molecule Steward - Dry Products – Lilly (BioSpace listing). This role provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. 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 proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as 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 that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Improve product/process robustness, reduce variability, and provide improvement in 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 Subject Matter Expert to collaborate with Development and manufacturing sites in optimizing key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submissions and responses. Prepare technical aspects of Regulatory/Quality documents and support regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations and apply them to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and related documentation. As a reviewer of technical reports, provide input on findings and conclusions. Mentor and provide coaching to develop other technical resources on scientific approach, technology, and business approach and behaviors. Achieve network level results for Lilly’s dry products (oral solid dosage forms) and influence global leadership to drive improvements and resolve issues. Basic Requirements
Bachelor’s Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences
Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and audiences to influence and drive common understanding and actions. Ability to work independently and in teams. Provides partnership across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, and provides accommodations during the application process. For accommodation requests, please complete the documented process provided by Lilly. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer support networks for members and are open to all employees. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $112,500 - $195,800. Full-time employees may be eligible for a company bonus and comprehensive benefits including 401(k), medical/dental/vision, life insurance, vacation, and well-being programs.
WeAreLilly
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Sr Principal Scientist - Global Technical Services Molecule Steward - Dry Products – Lilly (BioSpace listing). This role provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. 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 proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as 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 that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Improve product/process robustness, reduce variability, and provide improvement in 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 Subject Matter Expert to collaborate with Development and manufacturing sites in optimizing key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submissions and responses. Prepare technical aspects of Regulatory/Quality documents and support regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations and apply them to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and related documentation. As a reviewer of technical reports, provide input on findings and conclusions. Mentor and provide coaching to develop other technical resources on scientific approach, technology, and business approach and behaviors. Achieve network level results for Lilly’s dry products (oral solid dosage forms) and influence global leadership to drive improvements and resolve issues. Basic Requirements
Bachelor’s Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences
Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and audiences to influence and drive common understanding and actions. Ability to work independently and in teams. Provides partnership across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, and provides accommodations during the application process. For accommodation requests, please complete the documented process provided by Lilly. Lilly is an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer support networks for members and are open to all employees. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $112,500 - $195,800. Full-time employees may be eligible for a company bonus and comprehensive benefits including 401(k), medical/dental/vision, life insurance, vacation, and well-being programs.
WeAreLilly
#J-18808-Ljbffr