Senior Director, Drug Substance Development & CDMO Strategy

Altimmune; Morristown (NJ); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Altimmune in Morristown, NJ is seeking a Senior Director to lead drug substance development and manufacturing strategy for peptide APIs, interfacing with external CDMOs and internal Quality, Regulatory, and program teams.

The role requires 10+ years in industry and a strong track record in DS process development, scale-up, and regulatory CMC leadership. Hybrid work arrangement supports collaboration and strategic execution.

Qualifications

• PhD in chemistry or related field with 10+ years of industry experience.
• Leadership of drug substance process development and external GMP manufacturing.
• Strong expertise in peptide or complex API development including scale-up and transfer.
• Experience managing CDMOs and external multidisciplinary teams.
• Knowledge of cGMP, process validation, risk management, and regulatory expectations.
• Experience authoring regulatory CMC sections and Health Authority responses.
• Ability to translate complex data into decisions and executive recommendations.
• Excellent written and verbal communication and collaboration skills.

Responsibilities

• Own DS CMC strategy from development through late-stage and commercial readiness.
• Lead peptide API development, scale-up, purification, and technology transfer.
• Provide leadership over CDMO activities, investigations, CAPAs, and risk assessments.
• Establish phase-appropriate control strategies using QbD principles.
• Drive process characterization, validation readiness, and PPQ planning.
• Lead DS comparability assessments and risk evaluations on changes.
• Collaborate with Process Analytics for method development and transfer.
• Prepare regulatory CMC content and support Health Authority interactions.
• Ensure supply plans and CDMO deliverables align with program needs.
• Build relations with external manufacturers and governance structures.
• Lead cross-functional teams and mentor DS scientists.

Skills

Leadership

Peptide API development

CDMO management

cGMP knowledge

Regulatory CMC

Technical communication

Project leadership

Education

PhD in chemistry or related field

MS/BS with commensurately greater experience

Tools

QbD principles

DoE

CPP/CQA analysis

Job description

Altimmune in Morristown, NJ is seeking a Senior Director to lead drug substance development and manufacturing strategy for peptide APIs, interfacing with external CDMOs and internal Quality, Regulatory, and program teams.

The role requires 10+ years in industry and a strong track record in DS process development, scale-up, and regulatory CMC leadership. Hybrid work arrangement supports collaboration and strategic execution.