Senior Manager Manufacturing - USP (a), Solothurn
Job Title:
Senior Manager Manufacturing
Job Category:
Manufacturing
Description:
The successful candidate will provide technical and scientific support to manufacturing shopfloor activities, ensuring timely completion of tasks and adherence to compliance standards.
Main Responsibilities:
* Subject Matter Expertise: Act as an expert on manufacturing equipment and automated processes for Upstream Drug Substance Biologics.
* Resource Allocation: Partner with direct manager to assign resources for tech transfers, drive continuous improvement, and ensure manufacturing instructions are clear, safe, and compliant.
* Coaching and Training: Coach and train cross-functionally to meet career goals and business objectives, or contribute individually in technical instruction management for specific manufacturing process portions.
* Change Control: Initiate, own, and manage Manufacturing focused Change Controls, CAPAs, and Planned Exceptions.
* Process Improvement: Continuously improve and coach Manufacturing Associates on main area expertise and side processes, increasing productivity through intra, cross-site, and cross-functional projects related to process and productivity improvements.
Requirements:
* Education: Bachelor or higher degree in Engineering or a related field.
* Experience: 8+ years' work experience within a GMP environment.
* Upstream Experience: Ideally for Drug Substance of Biologics.
* Manufacturing/Technical Knowledge: Strong knowledge of manufacturing/technical processes and/or scientific principles.
* QA and cGMP Principles: Strong understanding of basic QA and cGMP principles.
* Coaching and Trainer Skills: Coaching and trainer skills for Manufacturing related activities.
* Software Requirements: DeltaV experience is mandatory, Syncade is a plus.
* Languages: Strong documentation and communication skills in English for effective interaction with a cross-functional team.
The selected candidate will be part of a dynamic team contributing to the discovery, development, and delivery of innovative therapies to improve patients' lives.