Assistant Director / Associate Director, Pharmaceutical Development

Location: Not specified for the role; the organization is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.

Salary: $93,200–$186,749 for the Assistant Director position; $156,216–$190,120 for the Associate Director position.

Company

Develops RNA-targeted medicines and gene-editing approaches for serious diseases, with a pipeline spanning neurology, cardiology, and other areas of high unmet need.

What you will do

• Author and coordinate drug product CMC sections for INDs, IMPDs, NDAs, briefing packages, and regulatory responses.
• Translate formulation, manufacturing, analytical, stability, specification, and control-strategy data into clear regulatory narratives.
• Partner with Pharmaceutical Development, Analytical, Quality, Regulatory CMC, Clinical Supply, Device, Project Management, and external stakeholders.
• Lead document planning, content integration, version control, review cycles, comment reconciliation, and finalization.
• Develop templates, best practices, and workflows to improve CMC authoring quality and efficiency.
• Support drug product formulation and manufacturing process development, late-stage programs, lifecycle changes, comparability arguments, and global expansion activities.

Requirements

• BA/BS or higher in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline.
• Minimum preferred experience: 8 years with a BA/BS, 6 years with an MA/MS, or 3 years with a PhD in drug product development.
• Experience in sterile drug product development and manufacturing, including CMC authoring for regulatory submissions.
• Strong scientific and regulatory writing skills, with experience preparing technical and administrative CMC documents in controlled documentation systems.
• Knowledge of FDA, ICH, USP, ISO, and other pharmaceutical development and CMC guidance.
• Strong data interpretation, organizational, project management, communication, and laboratory skills, with the ability to manage multiple time-sensitive deliverables independently.

Culture & Benefits

• Work in an environment focused on innovation, scientific excellence, and meaningful impact for patients.
• Collaborate across internal functions, external partners, and vendors.
• Benefits package is offered.
• Onsite, hybrid, and remote work environments are supported at the organizational level; the specific arrangement for this role is not stated.