Job Description

Assoc. Director of Support Operations (m/f/d)

The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the late-stage and commercial launch of programs. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.

The Assoc. Director of Support Operations (m/f/d) will be a member of the Biotech Manufacturing Leadership team, reporting to the Head of Manufacturing. The successful candidate will lead the support teams including Material management in the GMP shop floor area, Solution Supply execution and a team of delivering excellence in the Manufacturing Operations Organization. This person will be a key stakeholder in the maintenance of the multiproduct strategy and will have a leadership role in the introduction of new processes, materials, and technologies to the facility as well as transfer of processes out.

• Leading a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-clinic.
• Overseeing the coordination efforts for Material Weight and Dispense, Solution Supply execution to meet Drug Substance Manufacturing Execution (Process Operations) requirements of New Product Introduction (NPI) schedule.
• Management of the team for Operational Excellence, Technology Excellence, Innovation Excellence and Business Excellence which includes hiring and building team capabilities to meet the facility's operational requirements.
• Overseeing the material management activities for the GMP areas, interfacing with the Supply Chain team and warehouse team and establishing standards for business processes associated with materials such as Kanban and VMI.
• Embedding a culture that aligns with the Ways of Working and is committed to both facility and site priorities.
• Overseeing production planning and associated activities, integrated with the Multiproduct platform.
• In partnership with the Assoc. Director of Process Operations, championing the implementation of the lights-out manufacturing philosophy. Establishing a working rhythm that allows for agility and movement of staff between Drug Substance Fed Batch and Continuous Manufacturing, and Solution Supply. This includes designing a flexible skill matrix for training aligned with the working rhythm.
• Ensuring operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA).
• As applicable to Solution Supply and Weigh and Dispense, accountable for the management of the Production Alarm System, Sample Management Processes, Change approver for MES, Delta V Recipes, and material BOMs .
• Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with network partners for a common approach.
• Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
• Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.

• Degree level qualification in science or engineering, with People Manager Experience .
• Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
• Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage.
• Delta V and MES (Manufacturing Execution System) knowledge and experience an advantage.