Senior Director, Drug Product CMC

Eli Lilly and Company

. Directly manage CROs and CDMOs .

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 drug product and formulation development, particularly for oral, subcutaneous, and intravenous dosage forms, while ensuring compliance with cGMP requirements. Proven ability to manage complex projects and collaborate across cross-functional teams to support nonclinical and clinical development.

Highest-signal resume keywords

Ph.D. In Chemistry Or Pharmaceutical Sciences10+ Years Of Drug Product/Formulation Development ExperienceExpertise In Oral, Subcutaneous, And Intravenous Dosage FormsDeep Technical Expertise In Poorly Soluble BCS Class II/IV CompoundsStrong Understanding Of cGMP Requirements

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Applicant Tracking System Keywords

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Hard Skills

Physicochemical CharacterizationFormulation DevelopmentAnalytical Characterization TechniquesHPLC/UPLCXRPDDSCTGADVSProject ManagementRegulatory Submissions

Soft Skills

Excellent Communication SkillsPresentation SkillsInterpersonal SkillsStrategic LeadershipProblem-Solving Capabilities

Industry Keywords

CRO ManagementCDMO ManagementNonclinical DevelopmentClinical DevelopmentFormulation Stability StudiesIND SubmissionsCTA SubmissionsCross-Functional CollaborationSupply Chain CoordinationCGMP Compliance

About the role

Key responsibilities & impact

Directly manage CROs and CDMOs
Execute physicochemical characterization and pre-formulation studies for New Chemical Entities
Design and develop nonclinical oral, subcutaneous, and intravenous formulations
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 formulation, DS and DP stability, and supply guidance at cross-functional meetings
Coordinate shipments supporting nonclinical and clinical development supply requirements
Assist with 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
Travel to domestic and international vendors

Requirements

What you’ll need

Advanced degree in Chemistry, Pharmaceutical Sciences, or a related discipline; Ph.D. is 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
Strong understanding of pharmaceutical sciences and engineering principles related to liquid and solid dosage form development from early-stage development through clinical and commercial manufacturing
Working knowledge of analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies
Experience managing external development and manufacturing partners, including CROs, CDMOs, and CMOs
Solid understanding of cGMP requirements
Ability to lead multiple complex programs in a fast-paced environment, with project management, prioritization, resource management, and organizational skills
Excellent communication, presentation, and interpersonal skills
Strategic, hands-on leadership with decision-making and problem-solving capabilities
Willing and able to travel domestically and internationally as needed

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
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities