BioSpace
Director/Sr Director/Executive Director - MSAT - Dry Products Network
BioSpace, Indianapolis, Indiana, us, 46262
Director/Sr Director/Executive Director - MSAT - Dry Products Network
The 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. Responsibilities
Serve as Manufacturing TS/MS representative to collaborate 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 and implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products, integrating disciplines such as engineering and analytical science on technical projects and process performance improvements. Achieve network level results that improve effectiveness of TS/MS, Lilly Manufacturing, or other business parts by driving significant organizational improvement and capability work. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites and offer additional technical support/guidance for external manufacturing as needed. Ensure experiments and technical work are well designed and appropriately rigorous, using first principles and theoretical knowledge to define scientific approaches. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Author technical reports and appropriate sections of regulatory submission and responses as needed, supporting regulatory reviews and inspections. Remain current on external pharmaceutical manufacturing trends and innovations, applying these to improve strategies and applications across sites and technologies. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, and business behaviors. Qualifications
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. PhD in Chemistry, Engineering, Pharmacy, or related science with minimum 10 years of direct experience in Dry products Manufacturing and Development/Commercialization is preferred. 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. Flexibility to interact with multiple partners/functions, regions, and cultures. Demonstrated strong technical leadership and communication skills, effectively influencing team actions. Ability to work well independently, as well as in teams, providing partnership and collaboration across multiple disciplines. Demonstrated strong analytical and problem‑solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation, please complete the accommodation request form
here
for further assistance. Lilly is proud to be 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$141,000 - $246,400
per year. Full‑time employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including 401(k) participation, pension, vacation, medical, dental, vision, life insurance, and well‑being benefits.
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The 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. Responsibilities
Serve as Manufacturing TS/MS representative to collaborate 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 and implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products, integrating disciplines such as engineering and analytical science on technical projects and process performance improvements. Achieve network level results that improve effectiveness of TS/MS, Lilly Manufacturing, or other business parts by driving significant organizational improvement and capability work. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites and offer additional technical support/guidance for external manufacturing as needed. Ensure experiments and technical work are well designed and appropriately rigorous, using first principles and theoretical knowledge to define scientific approaches. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience as a recognized Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Author technical reports and appropriate sections of regulatory submission and responses as needed, supporting regulatory reviews and inspections. Remain current on external pharmaceutical manufacturing trends and innovations, applying these to improve strategies and applications across sites and technologies. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, and business behaviors. Qualifications
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. PhD in Chemistry, Engineering, Pharmacy, or related science with minimum 10 years of direct experience in Dry products Manufacturing and Development/Commercialization is preferred. 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. Flexibility to interact with multiple partners/functions, regions, and cultures. Demonstrated strong technical leadership and communication skills, effectively influencing team actions. Ability to work well independently, as well as in teams, providing partnership and collaboration across multiple disciplines. Demonstrated strong analytical and problem‑solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation, please complete the accommodation request form
here
for further assistance. Lilly is proud to be 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$141,000 - $246,400
per year. Full‑time employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including 401(k) participation, pension, vacation, medical, dental, vision, life insurance, and well‑being benefits.
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