2 дня назад
Operations Manager, Global External Operations (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Operations Manager, Global External Operations (Biotech): Managing external manufacturing operations at contract manufacturing organizations to deliver clinical and commercial products on time and in full, with an accent on supply planning, CMO performance, quality, and cross-functional coordination. Focus on resolving supply constraints, leading technology transfers and launches, performing root cause analysis, and maintaining cGMP compliance across regulated manufacturing operations.
Location: Working from home in the United States; San Rafael and Novato, California
Company
BioMarin is a global rare disease biotechnology company developing and manufacturing medicines for people with genetically defined conditions.
What you will do
- Manage day-to-day external manufacturing operations at one or more contract manufacturing organizations for clinical and commercial products.
- Execute production plans, monitor CMO performance, identify supply constraints, and resolve operational issues to maintain uninterrupted supply.
- Coordinate cross-functional communications, meetings, dashboards, material movement, process changes, deviations, and corrective actions.
- Monitor production campaigns at CMOs and support technology transfers, new product launches, validation activities, and operational readiness.
- Develop CMO selection procedures and control systems while supporting contract negotiations and cost-of-goods reduction.
- Establish operational readiness and mitigation plans, support transitions from launch to commercial operations, and lead site exit projects when required.
Requirements
- At least five years of leadership experience in operations, supply chain, or quality.
- Bachelor’s degree in life sciences, business, supply chain management, or a related field.
- Strong understanding of manufacturing processes and unit operations, with experience in regulated GxP environments.
- Experience leading cross-functional, multidisciplinary teams and resolving short-term issues while improving long-term performance.
- Strong decision-making, stakeholder management, communication, organizational, influencing, and coaching skills.
- Experience in supply planning or inventory management; experience with CAPA, FMEA, and RCA in regulated manufacturing is desired.
Culture & Benefits
- Work-from-home arrangement.
- Collaboration with internal manufacturing, process development, regulatory, quality, procurement, and external CMO teams.
- Work across clinical and commercial manufacturing activities in a regulated biotechnology environment.
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