Senior Scientist/Principal Scientist, Drug Product Development at Eli Lilly and Company

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Highly motivated with ability to independently lead projects, including experimental design, execution, efficient use of data, multi-tasking, and collaboration across CMC functions and with medical, marketing, PK/PD, and toxicology
Good judgment and ability to escalate technical issues and risks in a timely manner
Authorship of technical reports and regulatory documents (IND/CTA, BLA/NDA)
Ability to present data at deep dive, formulation, and/or other technical forums
Familiarity with CT and commercial platform processes and working knowledge of CMO operations, as appropriate
Familiarity with API manufacturing process and its impact on drug product Critical Quality Attributes

Responsibilities

Independently lead projects, including experimental design, execution, and efficient use of data to plan next steps
Conduct studies to support manufacture of supplies for GLP studies and needed compatibility testing
Conduct pre-formulation characterization and formulation studies to develop clinical formulations and provide support for successful manufacture of clinical supplies
Technology transfer of formulation and/or manufacturing process to sites for CT and/or commercial manufacture
Work effectively with the Bioprocess organization in the definition of the API matrix and in the development of the formulated bulk
Work effectively with Analytical Development in the definition of Drug Product physical and chemical stability properties as well as coordination of analytical testing support
Conduct commercial development studies collaborating effectively with functions such as Engineering, Statistics, Technical Sciences/Manufacture Sciences, and manufacturing sites
Keep abreast of relevant new technologies/capabilities and regulatory initiatives/requirements; implement new capabilities as appropriate
Support organizational initiatives as required
Work effectively with external partners on outsourcing efforts and research collaborations
Ensure work is aligned with all relevant PR&D Development Quality standards

Skills

pre-formulation characterization

parenteral formulations

monoclonal antibodies

therapeutic proteins

peptides

oligonucleotide development

nanomedicines

lipid nanoparticles

LNPs

antibody drug conjugates

ADC

AAV

gene delivery

formulation development

technology transfer

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.

Land your dream remote job 3x faster with AI

Try Jobo Free