Beschreibung
Entreprise :
For our client, an international biotech company in Basel, we're looking for a Senior Manager Drug Product Manufacturing 80-100% (a) to start asap for a try&hire.
Hybrid work model.
Description du poste :
The Senior Manager DP Manufacturing will be the technical lead and primary contact responsible for managing commercial DP Contract Manufacturing Organizations (CMO's), and other third-party suppliers overseeing the tracking of ongoing manufacturing, implementing process improvements, completing quality investigations, and ensuring commercial supply levels are maintained.
The candidate will be responsible for the following tasks areas:
* Co-leads manufacturing activities and coordinating activities across a matrix team. A SME in DP manufacturing with extensive knowledge in development, quality, and regulatory requirements for manufacturing
* Manages all aspects of DP Manufacturing from authoring and revision of manufacturing documents (MBRs, Protocols, QRAs, etc.), including oversight of manufacturing operation, tech transfer, managing deviations, investigations, and relevant change actions, supporting product release, and ensuring the finished product arrives in warehouse for distribution
* Responsible for DP vendor selection process for new commercial suppliers or alternative suppliers as well as maintaining good work relationships with existing ones
* Develops and maintains DP manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource
* Coordinates periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items
* Maintains and follows through a consolidated Manufacturing action log to ensure all manufacturing related actions are completed on time
* Provides onsite process coverage as person-in-plant as needed
* Develops, collects appropriate internal and external metrics to measure CMO and company`s performance
* Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team
* Prepares Annual Product Reports with Manufacturing CMOs according to needs
* Collaborates with CMOs and colleagues to schedule and coordinate Steering Committee Meetings
* Collaborates with Quality and Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure compliance with GMP and timely resolution and closure
Description du profil :
The successful candidate must have:
* Bachelor degree or higher in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience
* 6-9 years of progressively responsible experience in Drug Product Manufacturing Small Molecules is a must
* Strong understanding of biopharmaceutical manufacturing including regulatory filings and quality inspections and audits
* Extensive knowledge of current Good Manufacturing Practices (cGMPs)
* Demonstrated experience with preparing/reviewing annual product review/product quality review reports
* Contract service provider experience
* Able to operate effectively and with a strong sense of urgency in a fast-paced environment
* Outstanding communicator: clear, concise, well organized and appropriate to the audience
* Business fluency in English, additionally German and/or French is a plus
* Domestic and International travel is required for this role