Senior Director, Drug Product CMC

Eli Lilly and Company

. Lead work with external vendors and oversee nonclinical formulation development across programs .

Posted 10/23/2026full-timeRemote • United StatesSenior💰 $163,500 - $264,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in nonclinical formulation development, including oral, subcutaneous, and intravenous dosage forms, with a strong foundation in pharmaceutical sciences and engineering principles. Proven ability to manage CROs and CDMOs while leading complex programs and ensuring compliance with cGMP requirements.

Highest-signal resume keywords

Ph.D. In Chemistry Or Pharmaceutical Sciences10+ Years Of Drug Product/Formulation Development ExperienceExpertise In Oral, Subcutaneous, And Intravenous Dosage FormsWorking Knowledge Of HPLC/UPLC And Analytical MethodologiesStrong Understanding Of cGMP Requirements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Formulation DevelopmentPhysicochemical CharacterizationPre-Formulation StudiesFormulation StrategiesAnalytical MethodologiesDrug Delivery SystemsRegulatory SubmissionsProject ManagementResource ManagementProblem-Solving

Soft Skills

Excellent Communication SkillsInterpersonal SkillsStrategic LeadershipDecision-MakingInfluencing Stakeholders

Tools & Technologies

HPLCUPLCXRPDDSCTGADVS

Industry Keywords

Nonclinical Formulation DevelopmentCRO ManagementCDMO ManagementCGMP ComplianceIND And CTA Regulatory Submissions

About the role

Key responsibilities & impact

Lead work with external vendors and oversee nonclinical formulation development across programs
Manage CROs and CDMOs
Execute physicochemical characterization and pre-formulation studies for New Chemical Entities
Design and develop nonclinical oral, subcutaneous, and intravenous formulations for stability, bioavailability, and effective drug delivery in animal models
Design and oversee nonclinical formulation stability and compatibility studies
Support clinical formulation development of oral solid dosage forms
Author, review, and approve development and dose preparation protocols and reports
Review formulation-related sections of PK, PD, and safety study protocols and reports
Represent CMC and provide nonclinical formulation, drug substance and drug product stability, and supply guidance at cross-functional meetings
Coordinate shipments supporting nonclinical and clinical development supply requirements to CDMO and CRO sites
Compile formulation-related documentation for IND and CTA regulatory submissions
Collaborate with discovery, nonclinical, clinical, project management, legal, sourcing, supply chain, quality, regulatory, and other CMC functions
Report to the Executive Director, CMC
Travel to domestic and international vendors

Requirements

What you’ll need

Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. strongly preferred
10+ years of drug product/formulation development experience supporting nonclinical and clinical programs
Expertise across oral, subcutaneous, and intravenous dosage forms for small molecules
Deep technical expertise in developing and manufacturing poorly soluble BCS Class II/IV compounds
Formulation strategies for oral and parenteral delivery
Strong understanding of pharmaceutical sciences and engineering principles for liquid and solid dosage form development through clinical and commercial manufacturing
Working knowledge of HPLC/UPLC, XRPD, DSC, TGA, DVS, and related analytical and solid-state characterization methodologies
Experience managing CROs, CDMOs, and CMOs
Solid understanding of cGMP requirements
Ability to lead multiple complex programs in a fast-paced environment
Project management, prioritization, resource management, and organizational skills
Excellent communication, presentation, and interpersonal skills
Ability to influence stakeholders, build internal and external partnerships, and communicate complex scientific concepts to diverse audiences
Strategic, hands-on leadership, decision-making, problem-solving, resilience, and high-quality delivery
Willingness and ability to travel domestically and internationally as needed

Benefits

Comp & perks

Company bonus depending partly on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Employee assistance program
Fitness benefits
Employee clubs and activities
Employee resource groups and support networks