Senior Director of Drug Substance

Position Summary

We are seeking an experienced CMC leader to provide strategic and technical oversight for drug substance development and manufacturing programs from clinical development through commercial readiness. This individual will lead process development, scale-up, technology transfer, external manufacturing, validation readiness, and lifecycle management activities while serving as a key partner across Quality, Regulatory, Drug Product Development, Clinical Supply, and external manufacturing organizations.

The ideal candidate will bring strong expertise in drug substance development and GMP manufacturing, including experience supporting late-stage development programs. Experience with peptide APIs and peptide manufacturing processes is highly preferred, particularly for candidates who have led process development, scale-up, purification, and technology transfer activities.

Key Responsibilities

• Lead drug substance CMC strategy across development, manufacturing, validation, and commercialization activities.
• Provide technical leadership for process development, scale-up, characterization, technology transfer, and lifecycle management.
• Support development and manufacturing of complex APIs, including peptide-based drug substances where applicable.
• Lead external CDMO relationships, manufacturing campaigns, investigations, change controls, CAPAs, and process improvements.
• Establish phase-appropriate control strategies utilizing QbD principles and risk-based approaches.
• Drive process characterization, validation planning, PPQ readiness, and commercial manufacturing preparedness.
• Author and review regulatory CMC documentation and support interactions with health authorities.
• Partner with cross-functional stakeholders to ensure alignment of technical, regulatory, quality, and supply objectives.

Required Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related discipline, with approximately 10+ years of relevant pharmaceutical or biotechnology industry experience; MS/BS candidates with additional experience will also be considered.
• Demonstrated leadership in drug substance process development, technology transfer, and GMP manufacturing.
• Experience managing external manufacturing organizations and complex development programs.
• Strong understanding of process validation, quality systems, regulatory requirements, and lifecycle management.
• Experience authoring and reviewing CMC regulatory submissions and health authority responses.
• Excellent leadership, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience with peptide drug substance development and manufacturing, including synthesis, purification, scale-up, process characterization, and technology transfer.
• Familiarity with solid-phase peptide synthesis (SPPS) and peptide-specific control strategies.
• Experience advancing programs through Phase 3, process validation, and commercial readiness.
• Knowledge of QbD, DoE, CPP/CQA assessment, continued process verification, and modern process development approaches.
• Familiarity with global regulatory expectations for drug substance development and manufacturing.