Sr Mgr External Manufacturing

The Senior Manager  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 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

Program Management: Lead and manage external manufacturing programs with assigned CMOs. Responsibilities include developing and executing production plans, overseeing manufacturing operations, managing budgets, and ensuring on-time in-full delivery of program objectives.

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.

Risk Management: Proactively identify, assess, and escalate business-critical risks that may impact supply continuity or project timelines, and implement appropriate mitigation strategies.

Performance Monitoring: Track and evaluate supplier and CMO performance against established key performance indicators (KPIs) and provide regular updates and insights to management.

Continuous Improvement: Drive process improvements by identifying inefficiencies and proposing practical solutions to technical and operational challenges in collaboration with external partners.

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.
• A minimum of 10 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.
• Strong background in manufacturing operations with demonstrated leadership in executing technology transfers at GMP manufacturing sites; prior experience leading such efforts is preferred.
• Experience in the manufacturing of topical drug products is highly desirable.
• Demonstrated ability to work effectively in cross-functional teams and contribute to regulatory submissions and pre-approval inspection (PAI) 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 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 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!