BioSpace
Sr Principal Scientist - Global Technical Services Molecule Steward - Dry Produc
BioSpace, Indianapolis, Indiana, us, 46262
Sr Principal Scientist – Global Technical Services Molecule Steward – Dry Products
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, Lilly is committed to discovering and delivering life‑changing medicines, improving disease understanding, and giving back to communities through philanthropy and volunteerism. We’re looking for individuals determined to make life better for people worldwide. Position Brand Description
Provides technical leadership for drug product manufacturing processes under development and in commercial production within 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; 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 technical leadership for manufacturing process transfers between Lilly and external manufacturing sites, and additional technical support for external manufacturing as needed. Ensure that experiments and technical work are well designed and appropriately rigorous; use 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 risk mitigation strategies. Leverage prior experience as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Author technical reports, regulatory submissions, and support regulatory reviews and inspections. Remain current on external pharmaceutical manufacturing trends and innovations to improve strategies. Prepare, review, and approve study designs, protocols, and other technical documentation; as a reviewer provide input on experimental findings. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, and business behaviors. Achieve network‑level results for Lilly’s dry products that improve the business and influence global leadership. 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, and GMP manufacturing. Additional Preferences
Strong technical leadership and communication skills; effectively communicate across disciplines and audiences. Ability to work well independently and in teams; provide partnership and collaboration across multiple disciplines. Strong analytical and problem‑solving abilities. Effective at integrating multiple technology disciplines to advance programs. Flexibility to interact with multiple partners, functions, regions, and cultures. Compensation & Benefits
Salary range: $112,500 – $195,800. Full‑time employees may also earn a company bonus depending on performance. Lilly offers a comprehensive benefit program including 401(k), pension, vacation, medical, dental, vision, insurance, flexible spending accounts, time‑off, leave of absence, wellness benefits, and employee assistance programs. EEO Statement
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. Lilly is dedicated to helping individuals with disabilities engage in the workforce and provides accommodations upon request.
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At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, Lilly is committed to discovering and delivering life‑changing medicines, improving disease understanding, and giving back to communities through philanthropy and volunteerism. We’re looking for individuals determined to make life better for people worldwide. Position Brand Description
Provides technical leadership for drug product manufacturing processes under development and in commercial production within 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; 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 technical leadership for manufacturing process transfers between Lilly and external manufacturing sites, and additional technical support for external manufacturing as needed. Ensure that experiments and technical work are well designed and appropriately rigorous; use 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 risk mitigation strategies. Leverage prior experience as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Author technical reports, regulatory submissions, and support regulatory reviews and inspections. Remain current on external pharmaceutical manufacturing trends and innovations to improve strategies. Prepare, review, and approve study designs, protocols, and other technical documentation; as a reviewer provide input on experimental findings. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, and business behaviors. Achieve network‑level results for Lilly’s dry products that improve the business and influence global leadership. 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, and GMP manufacturing. Additional Preferences
Strong technical leadership and communication skills; effectively communicate across disciplines and audiences. Ability to work well independently and in teams; provide partnership and collaboration across multiple disciplines. Strong analytical and problem‑solving abilities. Effective at integrating multiple technology disciplines to advance programs. Flexibility to interact with multiple partners, functions, regions, and cultures. Compensation & Benefits
Salary range: $112,500 – $195,800. Full‑time employees may also earn a company bonus depending on performance. Lilly offers a comprehensive benefit program including 401(k), pension, vacation, medical, dental, vision, insurance, flexible spending accounts, time‑off, leave of absence, wellness benefits, and employee assistance programs. EEO Statement
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. Lilly is dedicated to helping individuals with disabilities engage in the workforce and provides accommodations upon request.
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