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Senior Analytical Scientist – Analytical Sciences and Technology
Eli Lilly and Company. Support synthetic and biologic drug substance processes from process transfer through scale-up, optimization, and production .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical characterization and method development for synthetic and biologic drug substances, ensuring compliance with cGMP and regulatory standards. Capable of leading cross-functional teams and managing complex projects while driving innovation and change.
Highest-signal resume keywords
HPLC/UPLCGCLC-MS/LC-HRMSAnalytical Method DevelopmentCGMP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Chromatographic SystemsSpectroscopic MethodsAnalytical CharacterizationMethod ValidationProcess Analytical Technology
Soft Skills
Strong CommunicationOrganizational SkillsLeadership SkillsInterpersonal SkillsCollaboration Skills
Tools & Technologies
NIRRamanUV/VisFTIR
Industry Keywords
Pharmaceutical DevelopmentGMP ManufacturingRegulatory SubmissionsQuality AssuranceTechnical Mentorship
About the role
Key responsibilities & impact- Support synthetic and biologic drug substance processes from process transfer through scale-up, optimization, and production
- Transfer analytical methods from Product Research and Development laboratories and refine test methods for robustness, accuracy, and precision
- Implement analytical and Process Analytical Technology strategies for drug substance production
- Identify, develop, and deploy new technological solutions across site and network project teams
- Plan and manage short- and long-term development activities, technical agendas, timelines, and resource allocation
- Collaborate with development and manufacturing organizations to deliver material and information for clinical trials and regulatory submissions
- Serve as a subject matter expert and technical mentor on experimental design, data interpretation, and problem-solving
- Coordinate instrumentation across projects
- Author, review, or approve SOPs, batch records, technology transfer reports, deviation reports, process flow diagrams, regulatory submissions, patents, and scientific papers
- Present technical findings and project updates to ASAT and cross-functional teams
- Ensure activities comply with development, quality, regulatory, HSE, GLP, and GMP requirements
Requirements
What you’ll need- B.S. in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, Biophysics, Pharmaceutical Science, or a closely related STEM field, with at least 8 years of experience in analytical characterization using chromatographic systems coupled with various detectors; or an M.S. with at least 5 years of relevant analytical characterization experience
- Authorized to work in the United States on a full-time basis
- Extensive experience with HPLC/UPLC, GC, LC-MS/LC-HRMS, and spectroscopic methods such as NIR, Raman, UV/Vis, and FTIR
- Hands-on experience developing and validating analytical methods for synthetic and biologic drug substance, including method transfer into GMP manufacturing or QC operations
- Experience supporting pharmaceutical development and transitioning analytical methods from development into manufacturing and commercial testing environments
- Working knowledge of cGMP compliance requirements, with direct cGMP experience
- Strong communication, organizational, and leadership skills
- Ability to prioritize multiple activities and manage ambiguity
- Demonstrated success in persuasion, influence, and negotiation
- Ability to drive and embrace change in a dynamic environment
- Good interpersonal and collaboration skills
- 0–10% travel required
Benefits
Comp & perks- Company bonus depending in part on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Healthcare and dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities