Global Tech Services Lead, Dry Solid Dose Molecule Steward

BioSpace; Indianapolis (IN); On-site; USD 117,000 - 209,000; Full time

Job summary

Lilly in Indianapolis is seeking a Sr. Principal Scientist through Sr. Advisor to lead manufacturing science activities for solid oral dosage forms, bridging Product Development, CM&C, and manufacturing sites to commercialize new products.

The role requires deep technical expertise, cross-functional leadership, and the ability to design rigorous experiments, drive process transfers, prepare regulatory submissions, and mentor others while delivering strategic improvements across sites.

Qualifications

• BS, MS, and/or PhD in Chemistry, Engineering, Pharmaceutical Science, or related science.
• Minimum 7-10 years of direct experience in Oral Solid Dose Form Manufacturing and Development/Commercialization.
• A minimum of 3 years of commercial manufacturing support (post process validation) of solid oral dosage forms with ability to apply this experience to development of new solid oral dosage form products.
• Evidence of technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization, and commercial GMP manufacturing.

Responsibilities

• Serve as Manufacturing TS/MS representative to integrate commercialization work plans across Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new solid oral dosage forms.
• Leverage prior commercial manufacturing and development experience of solid oral dosage forms to anticipate commercial manufacturing challenges for new oral products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs.
• Ensure that experiments and technical work plans are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations.
• Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs.
• Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies.
• Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed.

Skills

Analytical skills

Technical leadership

Communication

Team collaboration

Education

BS/MS/PhD in Chemistry/Engineering/Pharmaceutical Science

Job description

Lilly in Indianapolis is seeking a Sr. Principal Scientist through Sr. Advisor to lead manufacturing science activities for solid oral dosage forms, bridging Product Development, CM&C, and manufacturing sites to commercialize new products.

The role requires deep technical expertise, cross-functional leadership, and the ability to design rigorous experiments, drive process transfers, prepare regulatory submissions, and mentor others while delivering strategic improvements across sites.