Senior Director, Drug Substance Development (Peptide API)

Altimmune, Inc.; Morristown (NJ); Hybrid; USD 240,000 - 360,000; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

Altimmune, Inc. in Morristown, NJ seeks a Senior Director, Drug Substance Development to lead DS CMC strategy, peptide API development, and external manufacturing collaborations.

The role interfaces with QA, Regulatory, and program teams, ensuring readiness for late-stage and commercial manufacturing. The candidate will provide strategic direction and hands-on technical depth, manage CDMOs, and communicate DS importance to senior leadership.

Qualifications

• PhD in chemistry, chemical engineering, pharmaceutical sciences, or related field with ~10+ years in industry.
• Leadership of drug substance process development and external GMP manufacturing for clinical-stage programs.
• Experience with peptide APIs, scale-up, purification, and tech transfer.
• Experience managing CDMOs and cross-functional teams in external manufacturing.
• Knowledge of cGMP, process validation, quality risk management, and regulatory expectations.

Responsibilities

• Own DS CMC strategy from development to late-stage/commercial readiness.
• Lead peptide API development, scale-up, purification, and tech transfer.
• Oversee CDMO activities, investigations, CAPAs, and risk assessments.
• Develop phase-appropriate control strategies linking CQAs and CPPs.
• Coordinate validation, PPQ readiness, and lifecycle management with QA/Regulatory.
• Mentor DS scientists and drive a culture of scientific rigor and collaboration.

Skills

CMC leadership

Process scale-up

External manufacturing

Regulatory readiness

QbD principles

Analytical transfer

Project leadership

Communication

Education

PhD in chemistry

MS/BS with experience

Tools

cGMP knowledge

Job description

Altimmune, Inc. in Morristown, NJ seeks a Senior Director, Drug Substance Development to lead DS CMC strategy, peptide API development, and external manufacturing collaborations.

The role interfaces with QA, Regulatory, and program teams, ensuring readiness for late-stage and commercial manufacturing. The candidate will provide strategic direction and hands-on technical depth, manage CDMOs, and communicate DS importance to senior leadership.