Revolution Medicines
Director, CMC Regulatory, Europe (m/w/x)
Vollzeitmit HomeofficeManagement
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RERevolution Medicines
Senior Director, Commercial Supply Chain, Europe (m/w/x)
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Leading European commercial supply chain for oncology product launches, managing packaging, serialization, and distribution to 3PLs. Commercial product launch preparation and execution experience required. 4-day work week, personal mentoring program.
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Anforderungen
- B.Sc. or M.Sc. in scientific field
- Commercial product launch preparation and execution experience
- Commercial secondary packaging and labeling experience
- Serialization experience
- Validation experience
- Contract packaging operation experience
- 3PL distribution operation experience
- Manufacturing and service agreements development experience
- Manufacturing and service agreements negotiation experience
- Manufacturing and service agreements execution experience
- Strategic project management experience
- Tactical/operational project management experience
- Good Manufacturing Practices (GMP) working knowledge
- Good Distribution Practices (GDP) working knowledge
- End-to-end pharmaceutical supply chain working knowledge
- Demand/supply planning working knowledge
- Small molecule drug development working knowledge
- Small molecule drug commercialization working knowledge
- Pharmaceutical commercial manufacturing working knowledge
- Regulatory working knowledge
- Quality assurance working knowledge
- Strong negotiation skills
- Solid project management skills
- Solid facilitation skills
- Solid problem-solving skills
- Solid organizational skills
- Solid time management skills
- Effective communication skills (verbal)
- Effective communication skills (written)
- Open communication skills
- Transparent communication skills
- Ability to work on multiple projects/tasks
- Ability to meet timelines
- Self-starter
- Comfort with ambiguity
- Comfort with complexity
- Ability to multi-task
- Consistent delivery of quality results
- Team-oriented
- Progressive thinker
- Enjoyment of innovative work environment
- Enjoyment of creative work environment
Aufgaben
- Establish and lead regional supply chain for European product launches
- Ensure finished goods are packaged, released, and delivered to the 3PL
- Manage commercial packaging, serialization, and artwork
- Oversee demand and supply planning, and inventory management
- Manage logistics and distribution for European supply chain
- Manage supply chain deliverables and timelines for product launches
- Collaborate with CMC lead, Regulatory, Quality, Marketing, Finance, Trade & Distribution, and CMOs
- Develop and execute regional supply strategy and business processes
- Align regional supply chain budget and FTE needs with global strategy
- Scale operations and resources as directed
- Lead secondary packaging and labeling activities
- Manage packaging design, component sourcing, and vendor selection
- Oversee serialization and validation of packaging activities
- Lead design, generation, approval, and implementation of new artwork
- Coordinate with Regulatory and Quality to meet local market requirements
- Ensure country-level serialization requirements are met
- Manage day-to-day exceptions for serialization
- Manage trade and logistics for commercial shipments into Europe
- Coordinate shipment priorities and timelines with CMOs and Commercial Trade and Distribution
- Manage shipping validation to support regulatory submission milestones
- Maintain accurate inventory and supply data
- Support implementation and use of ERP inventory capabilities, including Oracle NetSuite
- Establish planning parameters and monitor CMO execution
- Lead responses to shortages, packaging issues, or launch delays
- Evaluate impact of global CMC and regional labeling changes on commercial supply
- Develop regulatory and supply strategy with Regulatory
- Manage supply transitions
Berufserfahrung
12 - 18 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
GMPGDP
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Revolution MedicinesÜber das Unternehmen
RE
PharmaceuticalsBasel
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
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