Sr Dir Process Technologies in Westlake Village, California at Arcutis Biotherapeutics Inc

The Senior Director Process Technologies is a critical role operating at the juncture of activities related to GMP biologic product development and production supply from early-stage clinicals through scale-up and commercialization at contract manufacturing organizations (CMOs) and key suppliers. This individual will work collaboratively in a fast-paced environment, navigate ambiguities, and drive results to ensure delivery of program milestones.

Roles & Responsibilities

1. Manage a team of Scientists and Engineers in the biologic drug development 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.
2. Serve as a key technical lead for CDMO relationships, providing oversight for manufacturing readiness, campaign execution, issue resolution, and performance follow-up.
3. Identify process improvements and offer solutions to technical challenges and troubleshooting as needed with process and suppliers/CMO(s).
4. Coordinate with cross-functional teams with membership from Quality, Process Development, Analytical Development, Regulatory, and Supply Chain; manage team priorities based on Arcutis’ needs across programs.
5. Support compliant and reliable manufacturing operations through review of batch records, deviations, investigations, change controls, and risk assessments.
6. Collaborate closely with Quality, Regulatory, Analytical, Drug Product, Supply Chain, and Project Management teams to align technical strategy, timelines, and supply plans.
7. Contribute to the preparation, authoring, and review of technical reports, regulatory submissions, and responses to health authority questions, inspections, and audits.
8. Represent the function on CMC and project teams, supporting team objectives and key project deliverables.
9. 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.
10. Collaborate effectively with employees, contractors, and consultants to deliver organizational goals.

Education & Licenses and Experience

Degree in Life Sciences, Engineering, Supply Chain or related area. Master’s Degree or PhD related to Pharmaceutical Sciences or Manufacturing Engineering preferred. At least 10 years’ experience in the biotechnology/pharmaceutical industry with a minimum of 8 years of experience in a GMP manufacturing environment. Experience overseeing outsourced vendors in pharmaceutical industry

Experience in process engineering and Tech Transfers at GMP manufacturing facilities preferred.

Experience working cross functionally with CMC teams and involved with pharmaceutical new drug application (NDA) submissions and pre-approval inspection (PAI) readiness.

Competencies & Skills

• Experience with monoclonal antibody or fusion protein process development.
• 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.

Why Join Us?

Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting 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 are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology 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 looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

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