Sr Principal Scientist - Global Technical Services Molecule Steward - Dry Products at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Bachelor’s Degree or higher in Chemistry, Engineering, Pharmacy, or related science
Minimum 7-10+ years of dir

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 and 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 different disciplines such as 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 appropriate 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
Utilize in-depth understanding of materials, process, and product to 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 prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of 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 submission and responses as needed; prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed
Remain current on external pharmaceutical manufacturing trends and innovations; leverage these to improve strategies and applications for developing and controlling manufacturing processes
Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation; as a reviewer of technical reports, provide input on the experimental findings and conclusions
Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors
Achieve network level results for Lilly’s dry products (oral solid dosage forms) that improve the business; influence global leadership to drive improvements and resolve issues

Skills

Drug Product Manufacturing

Dry Products

Oral Solid Dosage Forms

Process Control Strategies

Manufacturing Process Transfer

Technical Leadership

Data Analysis

Analytical Science

Engineering

Regulatory Compliance

Quality Compliance

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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