DSP Manufacturing Manager

☞ Merck Group

View: 192

Update day: 20-03-2024

Location: Aubonne Vaud VD

Category: Production / Operation Planning / Projects

Industry: Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Your role :

The BPS Manufacturing Excellence department combines Cell banking, Scale-up / Tech Transfer and Large-scale (GMP and non-GMP) expertises for a fast and agile product development.

Our mission is to translate and scale-up our processes in development into highly automatized manufacturing processes delivering safe and efficacious Drug to patients.

As DSP Manufacturing Associate Manager / Manager, you are in charge of large-scale operations (from 50L- to 2000L-scale in Fed-Batch or continuous modes) for the production of materials supporting pre-clinical and clinical Phase I/II studies.

Anticipating the start-up and migration of operational activities to the Biotech Development Center (BDC), you will support all the topics in your scope of responsibility during the construction and qualification phases such as equipment qualification, documentation writing, automation topics…

The scope of the DSP Manufacturing Associate Manager / Manager is to:

  • Lead, develop and manage the DSP Team members
  • Support the scaling-up from 200L- to 2000L-scale of suitable processes suitable for manufacturing-applications
  • Produce at large-scale NBEs for pre-clinical or clinical studies
  • Be a key enabler for the implementation of new technologies at large-scale and of strategic roadmap project
  • Maintain documentation up-date in the respect of quality standards, GXP rules and ensure safety in the areas
  • Represent the department during audits
  • Apply sound technical and management principles in order to drive DSP operations in accordance with defined timelines and KPIs
  • Participate in the elaboration of reports, guidelines, regulatory support files, publications when required

Your Profile/ Minimal requirements :

  • M.Sc/Engineering degree with at least 5 years related experience in GMP/ GLP manufacturing operations or B.S. degree with at least 10 years related experience in GMP/ GLP manufacturing operations
  • 5+ years prior leadership/supervisory/ management experience.
  • Demonstrated knowledge of purification steps (Chromatography, filtrations…) is required
  • Experience in single-use platform and in stainless steel technology is preferred.
  • Excellent written and verbal communication skills are required.
  • Strong organization skills are required.
  • Language: Fluent in English – French is a plus
  • Knowledge of SAP, MES, Delta V and Trackwise is a plus
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Deadline: 04-05-2024

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