Eli Lilly and Company
Director/Sr Director/Executive Director - TS/MS - Dry Products Network
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for people determined to make life better for people around the world.
Company Overview Lilly is an innovation-driven corporation developing a growing portfolio of pharmaceutical products by applying the latest research from its worldwide laboratories and collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better through medicines and information for urgent medical needs. Founded over 145 years ago, the company values excellence, integrity and respect for people. Lilly is recognized as a supportive place to work, with employees driving innovation and making a difference by finding treatments for challenging diseases.
Position Brand Description Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network.
Key Objectives/Deliverables
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.
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 improvements and resolving issues; influence global leadership in driving improvements.
Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites and provide technical support/guidance for external manufacturing as needed. Drive shared learning, alignment and improvement across sites and network activity according to best practices.
Ensure experiments and technical work are well designed and rigorous. Use first principles to define scientific approaches supporting technical expectations. Improve product/process robustness and reduce variability across sites and technologies.
Collaborate with Project Managers on key product project plans and support timely delivery of milestones with risk mitigation strategies.
Leverage experience as a Subject Matter Expert to optimize key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs and identify and deploy new technology as appropriate.
Author technical reports and sections of regulatory submissions; prepare technical aspects of regulatory/quality documents and support regulatory reviews and inspections as needed.
Remain current on external pharmaceutical manufacturing trends to improve strategies for developing and controlling manufacturing processes.
Prepare, review, and approve study designs, protocols, technical reports, and related technical documentation; provide input as a reviewer of technical reports.
Mentor and develop other technical resources on scientific approach, technology, and business considerations.
Basic Requirements
Technical expertise in multiple areas, unit operations, and platforms related to technical support of dry products (oral solid dosage forms) for commercial manufacturing as well as development and commercialization of these dosage forms.
Bachelor’s Degree or Master’s in Chemistry, Engineering, Pharmacy, or related science with a minimum of 15–20 years of direct experience in Dry products Manufacturing and Development/Commercialization.
PhD in Chemistry, Engineering, Pharmacy, or related science with minimum of 10 years of direct experience in Dry products Manufacturing and Development/Commercialization is preferred.
Additional Preferences
Flexibility to interact with multiple partners/functions, regions, and cultures.
Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and audiences to influence actions.
Ability to work well independently and in teams; capable of leading cross-disciplinary collaboration.
Strong analytical and problem-solving abilities.
Ability to integrate multiple technology disciplines to drive programs forward.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance. This is for individuals to request accommodation as part of the application process.
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.
Our employee resource groups (ERGs) offer strong support networks and are open to all employees. Learn more about all of our groups.
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. Full-time employees are eligible for a company bonus and Lilly offers a comprehensive benefits program including 401(k), pension, vacation benefits, medical/dental/vision coverage, flexible benefits, life insurance, leave, and well-being programs.
#WeAreLilly
#J-18808-Ljbffr
Company Overview Lilly is an innovation-driven corporation developing a growing portfolio of pharmaceutical products by applying the latest research from its worldwide laboratories and collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better through medicines and information for urgent medical needs. Founded over 145 years ago, the company values excellence, integrity and respect for people. Lilly is recognized as a supportive place to work, with employees driving innovation and making a difference by finding treatments for challenging diseases.
Position Brand Description Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network.
Key Objectives/Deliverables
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.
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 improvements and resolving issues; influence global leadership in driving improvements.
Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites and provide technical support/guidance for external manufacturing as needed. Drive shared learning, alignment and improvement across sites and network activity according to best practices.
Ensure experiments and technical work are well designed and rigorous. Use first principles to define scientific approaches supporting technical expectations. Improve product/process robustness and reduce variability across sites and technologies.
Collaborate with Project Managers on key product project plans and support timely delivery of milestones with risk mitigation strategies.
Leverage experience as a Subject Matter Expert to optimize key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs and identify and deploy new technology as appropriate.
Author technical reports and sections of regulatory submissions; prepare technical aspects of regulatory/quality documents and support regulatory reviews and inspections as needed.
Remain current on external pharmaceutical manufacturing trends to improve strategies for developing and controlling manufacturing processes.
Prepare, review, and approve study designs, protocols, technical reports, and related technical documentation; provide input as a reviewer of technical reports.
Mentor and develop other technical resources on scientific approach, technology, and business considerations.
Basic Requirements
Technical expertise in multiple areas, unit operations, and platforms related to technical support of dry products (oral solid dosage forms) for commercial manufacturing as well as development and commercialization of these dosage forms.
Bachelor’s Degree or Master’s in Chemistry, Engineering, Pharmacy, or related science with a minimum of 15–20 years of direct experience in Dry products Manufacturing and Development/Commercialization.
PhD in Chemistry, Engineering, Pharmacy, or related science with minimum of 10 years of direct experience in Dry products Manufacturing and Development/Commercialization is preferred.
Additional Preferences
Flexibility to interact with multiple partners/functions, regions, and cultures.
Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and audiences to influence actions.
Ability to work well independently and in teams; capable of leading cross-disciplinary collaboration.
Strong analytical and problem-solving abilities.
Ability to integrate multiple technology disciplines to drive programs forward.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume, please complete the accommodation request form for further assistance. This is for individuals to request accommodation as part of the application process.
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.
Our employee resource groups (ERGs) offer strong support networks and are open to all employees. Learn more about all of our groups.
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. Full-time employees are eligible for a company bonus and Lilly offers a comprehensive benefits program including 401(k), pension, vacation benefits, medical/dental/vision coverage, flexible benefits, life insurance, leave, and well-being programs.
#WeAreLilly
#J-18808-Ljbffr