Senior Director, Drug Substance Development

Altimmune, Inc.

. Own the drug substance CMC strategy from development through late-stage clinical and commercial-readiness activities.

Posted 10/15/2026full-timeMorristown • New Jersey • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in drug substance CMC strategy, including process development, optimization, and regulatory submissions. Proven ability to lead cross-functional teams and manage external manufacturing partnerships while ensuring compliance with cGMP and regulatory standards.

Highest-signal resume keywords

PhD In Chemistry, Chemical Engineering, Or Pharmaceutical SciencesPeptide API DevelopmentCDMO ManagementRegulatory CMC AuthoringQbD-Based Process Control Strategies

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Process DevelopmentProcess CharacterizationTechnology TransferProcess ValidationQuality Risk ManagementChange ManagementStatistical Process AnalysisManufacturing TroubleshootingPhase 3 ProgressionSolid-Phase Peptide Synthesis

Soft Skills

LeadershipCommunicationCollaborationNegotiationProject Leadership

Tools & Technologies

Advanced Process AnalyticsData-Driven Process MonitoringAutomation

Industry Keywords

CGMPCMC Regulatory ExpectationsICH Q7ICH Q8ICH Q9ICH Q10ICH Q11ICH Q12ICH Q14FDA/EMA Expectations

About the role

Key responsibilities & impact

Own the drug substance CMC strategy from development through late-stage clinical and commercial-readiness activities.
Lead peptide API process development, optimization, scale-up, robustness, characterization, and technology transfer.
Provide technical leadership and oversight of CDMO development plans, manufacturing campaigns, investigations, deviations, change controls, CAPAs, risk assessments, and continuous improvement.
Establish phase-appropriate QbD-based process control strategies.
Drive process characterization, validation strategy, PPQ readiness, continued process verification planning, and commercial manufacturing readiness.
Lead drug substance comparability assessments and technical risk evaluations.
Partner with Process Analytics on analytical method development, validation, transfer, trending, and data interpretation.
Author, review, and approve CMC content for regulatory submissions and responses; support Health Authority interactions.
Align manufacturing plans, material availability, timelines, and CDMO deliverables with program and clinical supply requirements; mitigate risks.
Build and manage relationships with external manufacturing partners, including governance, escalation, performance oversight, and supplier evaluation.
Lead cross-functional technical teams and communicate strategy, risks, decisions, and recommendations to CMC and senior leadership.
Mentor and develop CMC scientists.

Requirements

What you’ll need

PhD in chemistry, chemical engineering, pharmaceutical sciences, or a related discipline with approximately 10+ years of relevant industry experience; or MS/BS with commensurately greater experience.
Demonstrated leadership of drug substance process development and external GMP manufacturing for clinical-stage pharmaceutical or biotechnology programs.
Strong expertise in peptide or complex API development, including process scale-up, purification, process characterization, technology transfer, and manufacturing troubleshooting.
Demonstrated experience managing CDMOs and influencing multidisciplinary teams in a virtual or externally partnered manufacturing model.
Strong working knowledge of cGMP, process validation, quality risk management, change management, and CMC regulatory expectations for late-stage development.
Experience authoring and reviewing regulatory CMC sections and supporting responses to Health Authorities.
Ability to translate complex technical data into clear decisions, risk assessments, development plans, and executive-level recommendations.
Excellent written and verbal communication, collaboration, negotiation, and project leadership skills.
Preferred: Direct experience with therapeutic peptide APIs and solid-phase peptide synthesis, large-scale purification, isolation, and related control strategies.
Preferred: Experience progressing a drug substance process through Phase 3, process validation/PPQ, regulatory submission, and commercial readiness.
Preferred: Experience with QbD, DoE, CPP/CQA assessment, statistical process analysis, and continued process verification.
Preferred: Familiarity with ICH Q7, Q8, Q9, Q10, Q11, Q12, Q14, and relevant FDA/EMA expectations.
Preferred: Experience evaluating or implementing manufacturing innovation, advanced process analytics, modeling, automation, or data-driven process monitoring.