Senior Manager, Drug Substance Development

This role is a key member of the Process Technology team, responsible for advancing drug substance development activities across programs. The candidate must work collaboratively in a fast-paced environment, navigate ambiguity, and drive results. This position reports to the Senior Director, Process Technologies and Manufacturing, and serves as a strategic partner across cross-functional teams.

Responsibilities

• Lead drug substance development activities across preclinical, clinical, and commercial programs, including technology transfer, process characterization, validation support, lifecycle management, and support for IND, BLA/MAA, and commercial launch activities.
• Serve as a key technical lead for CDMO relationships, providing oversight for manufacturing readiness, campaign execution, issue resolution, and performance follow-up.
• Support compliant and reliable manufacturing operations through review of batch records, deviations, investigations, change controls, and risk assessments.
• Collaborate closely with Quality, Regulatory, Analytical, Drug Product, Supply Chain, and Project Management teams to align technical strategy, timelines, and supply plans.
• Contribute to the preparation, authoring, and review of technical reports, regulatory submissions, and responses to health authority questions, inspections, and audits.
• Represent the function on CMC and project teams, supporting team objectives and key project deliverables.
• Plan, design, and execute univariate and multivariate drug substance process characterization and validation studies with external sites, including development of small-scale models, quality oversight, and timely execution.
• Collaborate effectively with employees, contractors, and consultants to deliver organizational goals.

Requirements

• Advanced degree in chemical engineering, biochemical engineering, biochemistry, biotechnology, pharmaceutical sciences, or a related scientific discipline required; MS or PhD preferred.
• 8+ years of drug substance development experience in the biopharmaceutical industry.
• Strong experience in drug substance development, including process development, technology transfer, manufacturing support, and regulatory CMC contributions for late-stage programs.

Skills

• Experience with monoclonal antibody or fusion protein process development is a plus.
• Experience with QbD methodologies and statistical analysis using JMP.
• Strong knowledge of biologics drug substance processes, including upstream and downstream operations, scale-up, process characterization, validation support, and technical troubleshooting.
• Hands-on experience working with CDMOs and external partners in development and manufacturing settings.
• Excellent communication, collaboration, and project management skills, with strong attention to detail and the ability to work independently and effectively across technical and cross-functional teams.
• Proven ability to manage multiple priorities in a fast-paced environment, with flexibility to travel domestically and internationally as needed.

Travel may be required for up to 25% of time worked.

About the Company

Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases. Our pipeline is one of the more robust and exciting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We focus on filling the innovation gap in medical dermatology drug development by applying deep clinical, product development, and commercial expertise to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are nimble, collaborative, and passionate about achieving our mission.