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Principal Scientist, Formulations, Br&D

2-5 years
$63,000 – $162,800 annually.
10 April 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title

Principal Scientist – Formulations, BR&D

Location

Indianapolis, Indiana, United States

Company

Eli Lilly and Company

Category

Research & Development

Job Type

Full Time | Regular

Job ID

R-72657

Position Summary

The Lilly Bioproduct Research and Development (BR&D) organization is seeking a Principal Scientist to lead formulation development for parenteral drug products, including monoclonal antibodies, novel proteins, peptides, oligonucleotides, gene therapies (e.g., AAV), lipid nanoparticles, and Antibody-Drug Conjugates (ADCs). The role involves formulation and process development through all clinical stages, technology transfer, and regulatory document authorship, with an emphasis on innovation in drug delivery strategies.

Key Responsibilities

  • Independently lead experimental design, execution, and data interpretation for drug product development.

  • Conduct pre-formulation characterization and develop clinical formulations.

  • Support manufacturing of clinical supplies and GLP study materials.

  • Identify, escalate, and solve technical issues promptly.

  • Author technical reports and contribute to regulatory documents (IND/CTA, BLA/NDA).

  • Present data at internal technical forums and deep dives.

  • Support technology transfer to clinical trial (CT) and commercial manufacturing sites.

  • Collaborate with Bioprocess, Analytical Development, and other CMC functions.

  • Stay abreast of new technologies and regulatory trends; implement improvements as appropriate.

  • Manage external partnerships and collaborations.

  • Perform sample forecasting, database management, and data compilation.

Education Requirements

  • Master’s degree with 2–5 years of industry experience; OR

  • Bachelor’s degree with 5+ years of industry experience

  • Fields: Pharmaceutical Science, Chemistry, Biochemistry, or related discipline.

Additional Skills/Preferences

  • Strong background in parenteral formulation development and stability of biologics and genomic medicines.

  • Hands-on formulation and biophysical/analytical characterization skills.

  • Familiarity with manufacturing processes, technology transfer, and CMO operations.

  • Advanced computer skills (e.g., modeling, database creation, statistical analysis) preferred.

  • Strong communication skills and ability to collaborate across disciplines.

  • Experience in oligonucleotide, viral vector, or cell therapy formulation is a plus.

  • Understanding of analytical techniques for proteins, peptides, AAVs, and oligonucleotides.

Compensation

  • Anticipated Salary Range: $63,000 – $162,800 annually.

  • Eligible for company bonus program (based on company and individual performance).

Benefits

  • 401(k) plan and pension

  • Vacation and paid time off

  • Medical, dental, vision, and prescription drug benefits

  • Flexible spending accounts (healthcare, dependent care)

  • Life insurance and death benefits

  • Wellness programs (EAP, fitness benefits, clubs and activities)

  • Other leave of absence benefits

Physical Demands

  • Consistent with laboratory environment (e.g., standing, benchwork).

Work Environment

  • Laboratory-based work environment.

Equal Opportunity Employer

Lilly is an equal opportunity employer dedicated to diversity and inclusion.

Employee Resource Groups (ERGs)

Includes groups such as the Black Employees at Lilly, Organization of Latinx at Lilly (OLA), Lilly India Network, PRIDE (LGBTQ+ Allies), Women’s Initiative for Leading at Lilly (WILL), and others.

Accommodation

Applicants needing accommodations during the application process can request assistance via the Accommodation Request Form.