Senior Director, Drug Substance Development

Altimmune•Morristown, NJ

2d•Hybrid

About The Position

Altimmune (NASDAQ: ALT) is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company's lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com. Summary of 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 role will lead phase-appropriate development, scale-up, technology transfer, manufacturing, control strategy, validation readiness, and lifecycle activities for peptide drug substance programs, while serving as a key technical interface with external CDMOs and internal Quality, Regulatory, Drug Product, Clinical Supply, and program teams. This position will report to the Vice President, CMC and should provide both hands-on technical depth and senior-level external manufacturing leadership as Altimmune advances late-stage clinical programs. This position is based in Morristown, NJ, and will be hybrid (2-4 days per week in the office).

Requirements

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.

Nice To Haves

Direct experience with therapeutic peptide APIs and solid-phase peptide synthesis, large-scale purification, isolation, and related control strategies.
Experience progressing a drug substance process through Phase 3, process validation/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, Q14, and relevant FDA/EMA expectations for drug substance development and manufacture.
Experience evaluating or implementing manufacturing innovation, advanced process analytics, modeling, automation, or data-driven process monitoring is a plus.

Responsibilities

Own the 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, with particular emphasis on synthesis, purification, isolation, and drug substance handling.
Provide technical leadership and oversight of CDMO activities, including 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 associated with process, scale, site, raw-material, equipment, or analytical changes.
Partner closely with Process Analytics to ensure appropriate analytical method development, validation, transfer, trending, and data interpretation for drug substance.
Author, review, and approve high-quality CMC content for regulatory submissions and responses; provide technical support for Health Authority interactions.
Ensure drug substance manufacturing plans, material availability, timelines, and CDMO deliverables remain aligned with program and clinical supply requirements; proactively identify and mitigate supply and execution risks.
Build effective relationships with external manufacturing partners, including governance, technical decision-making, escalation, performance oversight, and evaluation of new suppliers or manufacturing technologies.
Lead cross-functional technical teams and communicate drug substance strategy, risks, decisions, and recommendations clearly to CMC and senior leadership.
Mentor and develop scientists within the CMC organization and contribute to a culture of scientific rigor, ownership, collaboration, innovation, and continuous improvement.