Senior Director, Drug Substance Development

Altimmune•Morristown, NJ

1d•Hybrid

About The Position

The Senior Director, Drug Substance Development will provide strategic and technical leadership for drug substance development and manufacturing within Altimmune’s CMC organization. The position leads phase-appropriate development, scale-up, technology transfer, manufacturing, control strategy, validation readiness, and lifecycle activities for peptide drug substance programs. It serves as a key technical interface with external CDMOs and internal Quality, Regulatory, Drug Product, Clinical Supply, and program teams. The role reports to the Vice President, CMC and combines hands-on technical depth with senior-level external manufacturing leadership as Altimmune advances late-stage clinical programs. The position is based in Morristown, New Jersey, with a hybrid schedule of 2–4 days per week in the office. Altimmune is a late clinical-stage biopharmaceutical company developing therapies for serious liver diseases. Its lead candidate, pemvidutide, is a dual-action therapy targeting glucagon and GLP-1 receptors and is in development for MASH, alcohol use disorder, and alcohol-associated liver disease.

Requirements

PhD in chemistry, chemical engineering, pharmaceutical sciences, or a related discipline with approximately 10 or more years of relevant industry experience; alternatively, an MS or 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 late-stage CMC regulatory expectations.
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.
Direct experience with therapeutic peptide APIs and solid-phase peptide synthesis, large-scale purification, isolation, and related control strategies.
Experience advancing a drug substance process through Phase 3, process validation or PPQ, regulatory submission, and commercial readiness.
Experience with QbD, DoE, CPP/CQA assessment, statistical process analysis, and continued process verification.
Familiarity with ICH Q7, Q8, Q9, Q10, Q11, Q12, and Q14, and relevant FDA and EMA expectations for drug substance development and manufacture.

Nice To Haves

Experience evaluating or implementing manufacturing innovation, advanced process analytics, modeling, automation, or data-driven process monitoring.

Responsibilities

Own drug substance CMC strategy from development through late-stage clinical and commercial-readiness activities, integrating process, analytical, manufacturing, control strategy, comparability, and regulatory requirements.
Lead peptide API process development, optimization, scale-up, robustness, characterization, and technology transfer, particularly synthesis, purification, isolation, and drug substance handling.
Provide technical leadership and oversight of CDMO development plans, manufacturing campaigns, technical investigations, deviations, change controls, CAPAs, risk assessments, and continuous improvement.
Establish phase-appropriate process control strategies using QbD principles, linking CQAs, CPPs, process understanding, specifications, and analytical controls to support validation and lifecycle management.
Drive late-stage process characterization, validation strategy, PPQ readiness, continued process verification planning, and commercial manufacturing readiness in partnership with Quality and Regulatory.
Lead drug substance comparability assessments and technical risk evaluations related to process, scale, site, raw-material, equipment, or analytical changes.
Partner with Process Analytics on analytical method development, validation, transfer, trending, and interpretation of drug substance data.
Author, review, and approve CMC content for regulatory submissions and responses, and provide technical support for Health Authority interactions.
Keep drug substance manufacturing plans, material availability, timelines, and CDMO deliverables aligned with program and clinical supply needs; identify and mitigate supply and execution risks.
Build relationships with external manufacturing partners through governance, technical decision-making, escalation, performance oversight, and evaluation of suppliers or manufacturing technologies.
Lead cross-functional technical teams and communicate strategy, risks, decisions, and recommendations to CMC and senior leadership.
Mentor and develop CMC scientists and foster scientific rigor, ownership, collaboration, innovation, and continuous improvement.