Biogen Idec
Zug, Switzerland
Requisition Number: 23810BR
Job Description
Overview:
Manages a broad spectrum of packaging operations at assigned CMO sites, taking responsibility for the daily CMO interaction. Position is responsible for establishing contract relationships with contract vendors; Drives the process identification and evaluation of potential new contractors, including the management of technical issues, inquiries, vendor evaluation and selection. Supports Regulatory and assists in authoring filings. Acts as SME for quality deviation and investigations. Leads cross functional supply teams. Identifies and implements continuous improvement opportunities at individual contract sites. Position requires travel domestically and international to contract sites.
Responsibilities:
- Managing CMO (Contract Manufacturing Organizations) relationships for several assigned CMO’s for external packaging
- Driving the process optimization and internal coordination of projects and activities due to ensure efficient and compliant contract manufacturing process for outsourced packaging activities for commercial programs
- Working with internal groups (Strategic Sourcing, Regulatory, Engineering and QA) to ensure operations at CMO sites conform to cGMP and financial guidelines. Project management including frequent contact and collaboration with Planning, Logistics and Materials management to meet production requirements. Collaboration with other functions to manage activities at contract site
- Implementing changes at CMO sites according to GMP and regulatory guidance. Managing Core changes through Biogen Idec’s trackwise system
- Leading for Quality deviation investigations for CMO sites
Qualifications
- Minimum 3 years’ experience working within Biotech/Pharmaceutical supply chain field
- Knowledge of cGMP’s together with practical application is required
- Complete understanding of manufacturing operations and validation activities required for machinery in cGMP manufacturing operations
- Ability to demonstrate procurement compliance and ethics. Mastery of tools for procurement, forecasting, planning and materials management
- Demonstrates a strong ability to identify, analyze and solve problems. Accountable for the development and implementation of solutions
- Possesses a good balance between being detail-orientated and setting direction/approach
- Previous experience in working in cross functional teams
- Excellent written and verbal communication skills; must be able to communicate at all levels of the organization
- Bachelor’s Degree in Business, Life Science/ Quality/Engineering or Education in a related field