MSD Associate Director - Drug Substance Support Operations m/f/d 

Switzerland, Lucerne 

475794351

Job Description

We are currently seeking an

Key Responsibilities:

The Associate Director of Drug Substance Support Operations has a variety of key responsibilities which include:

• Leading a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical or Commercial campaigns.

• Overseeing the coordination efforts for Material Weight and Dispense, Solution Supply execution to meet Drug Substance Manufacturing Execution (Shop Floor Operations) requirements of New Product Introduction (NPI) schedule.

• Management of the Senior Specialists (Operational Excellence, EHS) 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 Site 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 of the company

• Overseeing production planning and associated activities, integrated with the Site Multiproduct platform.

• In partnership with the Assoc Director of DS Process Operations, championing the implementation of the lights-out manufacturing philosophy.

• In partnership with the Assoc Director of DS Process Operations, championing the implementation of the lights-out manufacturing philosophy. Establishing a working rhythm that allows for agility and movement of staff between Cell Expansion, Process Platforms for 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).

• Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with network partners for a common approach.

• Supporting the deployment of phase-appropriate Quality Management Systems (QMS) within the Site, including Change and Deviation Management.

• 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.

• Championing Ways of Working around Operational Excellence as well as EHS requirements via Gemba and tools like Enablon, with the aim of building and maintain a strong EHS culture.

• 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.

Education/Qualifications:

• Degree level qualification in science or engineering .

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

• Proven experience in a leadership role with technical transfer experience in the biotech sector in Clinical Supply

• Working knowledge of cGMP regulations

• Demonstrated supervisory and leadership skills

• Fluency in English and German language skills

Preferred Skills and Experience:

• 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.

SCHACHEN, LUCERNE

Current Contingent Workers apply

No Travel Required

Not Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.