Senior Manager, External Manufacturing

Role Summary

The Senior Manager, 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.

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.

Qualifications

• 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.

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.

Education

• 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.

Additional Requirements

• Travel up to 30% as required to support business needs.