MSAT Senior Process Expert DSP Basel Biotech Manufacturing

La position

Basel Biotech Manufacturing produces biotech drugs such as monoclonal antibodies (mAb) and antibody-drug conjugates (ADC) for clinical use and commercial distribution. The MSAT department is a technology unit supporting production at Basel DS Manufacturing.

The Opportunity:

As a MSAT Process Performance Team Member with a focus on downstream processing, your main responsibilities will be in the area of:

• Building, sustaining and improving the technical capabilities in the group for the area of responsibilities of the Process Engineering chapters incl. coaching and mentoring of technical SMEs and provide recommendations for technical decisions

• Collaborating with technical experts across Roche to support strategic initiatives across the Roche manufacturing network and leading technology and innovation projects within the site and/or the network

• Embodying Lean Leadership principles and living a culture of continuous improvement to foster an environment of strong team spirit, timely and efficient communication, sense of urgency, high motivation and passion, in order to deliver mid/long term goals

• Supporting the analysis of end-to-end production processes and facility capabilities to identify opportunities for improvement regarding safety, quality, robustness of supply, reduce operational costs and lead times, and prevent problems

• Planning and coordination of troubleshooting activities in collaboration with the pilot laboratories, production, and the quality department

• Driving technical standardization and knowledge exchange in-between SUT, ADC and MAB stainless steel plant, serving as an SME in inspections and as a lead of root cause analysis teams for complex deviations

• Being a Site Representative in Network Teams i.e. UoTs, (Unit operation Teams), MPET (Manufacturing Process Evaluation Team) and becoming Site SME and decision marker in strategic technical changes

• Becoming the primary contact for partners in the Roche Biologics Drug Substance network (such as other manufacturing sites, PTI, PTD, DSTLs, other functions and external partners) for the exchange and collaboration in the area of MSAT

• Owner of the production processes (interface between Manufacturing and MSAT) as well as carrying out data analysis as part of process monitoring

Who You Are:

You have an academic degree in a scientific or technical area (Master or PhD), preferably in biotechnology, biochemistry or bio/chemical process engineering. Furthermore:

• 8+ years of relevant experience in industry (manufacturing), 6+ years of relevant experience in manufacturing with bioprocesses, and needs experience working in a cGMP environment

• Good knowledge of safety principles, quality systems, and cGMP and has done relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting

• Extensive knowledge in the field of downstream processing of biotechnologically manufactured products with the ability to adapt to a rapidly changing environment with changing priorities and to react flexibly to requests

• Very good (intercultural) communication skills with fluency in German and English

• Knowledge of process validation, process transfers, and single-use technologies would be an advantage

On-call Service occasionally possible.

Roche est un employeur offrant l'équité en matière d'emploi.

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