Senior Manager, Drug Substance Development

Arcutis Biotherapeutics • US,

7d • $150,000 - $165,000

About The Position

The Senior Manager, Drug Substance Development is a key member of the Process Technology team, responsible for advancing drug substance development activities across programs. To be successful in this role, the candidate must be able to 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.

Requirements

• Advanced degree in chemical engineering, biochemical engineering, biochemistry, biotechnology, pharmaceutical sciences, or a related scientific discipline required; MS or PhD preferred, with 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, is highly desirable.
• 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.

Nice To Haves

• Experience with monoclonal antibody or fusion protein process development is a plus.

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.

Benefits

• Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior