External Manufacturing Operations Lead

Contenuto del lavoro

Are you passionate about project management ? Are you often described as a very organized person, multi-tasked ? With a real interest in the pharmaceutical industry ?

For an international pharmaceutical company, we’re looking for an External Manufacturing Operations Lead.

Your principal’s tasks will be to interact with Contract Manufacturers (CMOs, internal/external) and to support and manage the technical projects at CMOs.

Main Tasks

• Ensures efficient Operational interaction with CMOs :
• Manage the compliance of GMP documentation at CMOs
• Make sure of the efficient communication with CMOs by organizing regular meeting
• Track production and technical transfer activities at CMOs in line with the company procedure
• Support process and analytical troubleshooting in a timely manner
• Ensure timely delivery by tracking the release process and by organizing the samples shipments
• Manage deviation and change control in the company system and provide timely response to CMOs
• Monitor process performance at CMOs by reviewing the production data trending and annual product review.
• Ensures long term management of CMOs for commercial production in performing regular risk analysis of the CMOs as defined by the company procedure. At the same time, make sure the project is on track and according to agreed timelines.
• Ensures effective implementation of lifecycle projects:
• Define process improvement implementation roadmap in collaboration with internal functions and CMOs
• Lead project for implementation (tech transfer) / modification of manufacturing processes and analytical methods at CMOs.
• Manage and support process validation activities and take ownership of the manufacturing process
• Write/review the CMC sections to ensure coherence with the effective manufacturing process, but also the regulatory documents as required.
• Ensures effective coordination of technical information within the External Manufacturing Operations Bio DS team, by sharing information that can impact the product quality, process performance and CMO management.
  

Profile

• 10 years experience within CMO/external suppliers management
• Solid experience in managing and contributing to multidisciplinary project teams (internal and with CMOs). PMP is a plus, but not mandatory.
• Leadership skills, including training, coaching and disciplinary enforcement
• Familiarity with biological manufacturing processes, including fermentation and purification methods
• Skilled in writing and reviewing cGMP quality and regulatory requirements/submissions relating to biological products
• Knowledge of financials and budgeting processes
• Ability to define and implement a strategy
• Proposing actively improvements ideas, such as manufacturing operational improvements to yields or cost of goods, reduction in project timelines, increasing quality compliance for inspection readiness etc.
  

For this position, only candidates based in Switzerland and the EU will be accepted.

We’re looking forward to receive your applications !