Assoc Dir External Manufacturing at Arcutis Biotherapeutics Inc – Westlake Village, California

The Associate Director of External Manufacturing will play a pivotal role in overseeing activities related to the production and supply of clinical and commercial drug products. This role spans from late-stage clinical development through scale-up and commercial manufacturing and packaging at Contract Manufacturing Organizations (CMOs). The ideal candidate will thrive in a fast-paced, collaborative environment, effectively manage ambiguity, and consistently drive results to meet key program milestones.

Roles & Responsibilities

The Associate Director of External Manufacturing will be responsible for the following key activities, including but not limited to:

1. Program Management: Lead and manage external manufacturing programs with assigned CMOs. Responsibilities include developing and executing production plans, overseeing manufacturing and/or packaging operations, managing budgets, and ensuring on-time in-full delivery of program objectives.
2. Cross-Functional Coordination: Collaborate effectively with cross-functional teams, including Quality Assurance, Process Technologies, Quality Control, Analytical Development, Supply Chain and Regulatory Affairs to align priorities with corporate and program goals.
3. Risk Management: Proactively identify, assess, and escalate business-critical risks that may impact supply continuity or project timelines, and implement appropriate mitigation strategies.
4. Performance Monitoring: Track and evaluate supplier and CMO performance against established key performance indicators (KPIs) and provide regular updates and insights to management.
5. Continuous Improvement: Drive process improvements by identifying inefficiencies and proposing practical solutions to technical and operational challenges in collaboration with external partners.
6. Regulatory Support: Support the preparation and review of regulatory submissions and contribute to readiness activities for pre-approval inspections (PAIs), as needed.

Education and Experience

• Bachelor’s degree in Life Sciences, Engineering, Supply Chain, or a related area. A Master’s degree in Pharmaceutical Sciences or Manufacturing Engineering is preferred.
• 10-12 years of experience in the biotechnology or pharmaceutical industry, including at least 8 years in a GMP manufacturing environment.
• Proven experience managing Contract Manufacturing Organizations (CMOs) within the biopharmaceutical sector.
• Proven track record in clinical and commercial operations, tech transfer, scale-up, launch readiness, and life cycle management.
• Experience in the manufacturing and/or packaging of topical drug products is highly desirable.
• Demonstrated ability to work effectively in cross-functional teams and contribute to regulatory submissions and inspection readiness.

Additional Competencies & Skills

• Strong analytical and problem-solving capabilities, with solid scientific and/or technical knowledge related to pharmaceutical development and operations.
• High technical aptitude, with the ability to analyze and interpret complex data and operational scenarios.
• Proven project and team leadership skills, with a track record of effectively guiding cross-functional efforts.
• Demonstrates adaptability and proactive decision-making in a fast-paced, dynamic environment with minimal supervision.
• Exceptional organizational skills with the ability to manage multiple priorities and responsibilities while ensuring timely follow-through.
• Excellent verbal and written communication skills, with the ability to clearly convey technical and strategic information to diverse audiences.
• Ability to travel up to 30% as required to support business needs.

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!

This job description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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.

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