MSD Assoc Dir Engineering m/f/d 

Switzerland, Bern 

13782297

Job Description

Our Schachen site serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch.

As leader of the Process Engineering group at Werthenstein BioPharma Facility, you will be responsible for the evaluation and implementation ofnovel equipment, innovative processes, and the implementation of next generation technologies

The primary activities include but are not limited to the following activities:

• Inspire Diversity and Inclusion – building effective working relationship within a cross-functional team across different cultures and backgrounds.

• Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own leadership and technical/functional skills

• Lead tiered meeting structure coordinating activities locally and with international (US, Ireland) groups for implementation of new processes and technologies for Drug Substance manufacturing.

• Serve as a Subject Matter Expert for the implementation of new equipment to enhance manufacturing processes in a Good Manufacturing Practice (GMP) environment , preparing user requirements and capital funding requests.

  • Consolidate process-related knowledge and centralize it for efficient knowledge management.

  • Implement innovative technologies, software, and instruments to streamline processes and reduce the effort involved in manufacturing and administrative processes.

• A Change and QRA Champion within the organization and site, to introduce new technologies, digitization, and identify opportunities for innovative work methods.

• Responsible for the planning, allocation, and management of CAPEX projects to ensure efficient utilization of resources while adhering to budgetary constraints and timelines.

• Providing technical and functional oversight for various large and small projects managed by the team.

People Manager

• You will be responsible for establishing the vision and strategy for the Process Engineering Team. Additionally, you will set performance goals, conduct evaluations, and identify training and development opportunities for your team.

• Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful.

• Assessing workload, identifying gaps or imbalances, and reallocating resources or making hiring decisions to optimize staffing levels and ensure efficient operations.

• Foster a feedback culture within the team or organization, encouraging open and honest communication.

• Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.

• Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment , ideally with experience of single-use systems.

• Proven supervisory and leadership abilities/formal people management experience. Managed ideally a large team, including mentoring, development, and performance management.

• Possess a deep understanding of amanufacturing/operationalGMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing.

• Business Fluent oral / written communication skills in English (C1), and German (B1)

• DCS & automated manufacturing process knowledge and experience

• Extensive project management knowledge with relevant certifications.

• Experience in Quality Change Management Systems and regulatory inspections.

• Experience with Cross-Functional Investigations and Root Cause AnalysisTechniques.

• MES (Manufacturing Execution System) knowledge and experience

• Experience with continuous processing, including perfusion and/or multi-column chromatography (BioSMB, PCC or similar)

around us.

Current Contingent Workers apply

Not ApplicableNot Indicated

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