Drug Product MSAT Process Specialist

JETZT BEWERBEN DRUCKEN
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Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Drug Product MSAT Process Specialist

Background:

Drug Product MSAT Process Specialist is the first-line connector between PTT global MSAT and the internal and external manufacturing sites. In this role you will be responsible for enabling successful process industrialization by supporting during TRs, ERs, PPQ and launch phase, driving systematic process improvements according to product and portfolio needs, owning second source transfers and providing hands-on second-level commercial product support in case of investigations, CAPAs and troubleshooting in close partnership with local MSAT functions and PTT`s Product Stewards and Product Technical Leads. This is a highly specialized and execution-obsessed process expert role that provides technical support across the site network on both product-specic and multi-product needs. In this role, you may be asked to represent the technological needs of the network in key technical governance forums and senior stakeholder interactions, including the Global MSAT Leadership Team, PTT capability teams (e.g., Process Scientists, TPC, DSTS, and DPTC), Manufacturing Site Leadership Teams, CDMO Organization Leadership Teams, TPM Enabling Teams, PT Strategy and PTD-LTs.

Tasks & Responsibilities:

  • Support Product Technical Leads and Product Stewards to ensure process industrialization (e.g. facility t and manufacturability, PPQ support as needed, etc…), coordinate and execute process gap assessments, integrating identified risks into the risk log and developing mitigation strategies
  • Drive systematic process and continuous technical product health and supply improvements based on insights, including second supply and change source strategies
  • Execute validated state support activities, such as WCB shipment, sample coordination for additional studies, and non-routine sampling planning, and respond to evolving conditions to ensure compliance (e.g. VICs, RCAs, etc.)
  • Provide technical expertise to technical runs and engineering runs, internally and externally
  • Provide hands-on second-level support (commercial product support) in the case of investigations, CAPAs and troubleshoot in close partnership with the internal and external manufacturing network
  • Lead non-product specific RCAs and investigations on behalf of the internal manufacturing network
  • Leverage the pilot plant team to enable real-life and scaled experimentation to support process related projects (including validation studies) as well as process transfer to manufacturing sites
  • Ensure the implementation of network initiatives aligned and prioritized with manufacturing site plans
  • Incorporate/execute portfolio-wide impacting aspects (e.g. direct material changes; Health Authority requirements; etc.)
  • Perform defined technical Product Life Cycle activities to ensure product robustness from development through divestment
  • Execute process-related mitigation of complaints and deployment of CAPAs across multiple sites or products
  • Drive technical sustainability improvements for product, process, and technology, including digital advancements
  • Closely collaborates with global and site functions (sometimes external) and leadership, including other gMSAT and PTT teams, particularly close partnership with E2E Product Technical Leads and DS or DP Technical Leads
  • Serve as a digital enabler translating business needs to digital strategy and digital product development teams

Must Haves:

  • B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline with 3+ years of relevant industrial experience in platform specific technical process development, process engineering or manufacturing operations (e.g. DS Bio, DP SM, etc.), PhD can be of advantage
  • Technical Expertise: 3- years demonstrated experience in process engineering, technical process development, process validation or technology transfer, with pharmaceutical quality systems and industry-wide guidelines pertinent to platform specific process development and manufacturing, with regulatory submission and health authority requirements, and with platform specific technology, processes and equipment
  • Outstanding Communicator: Advanced level of verbal and written communication skills (e.g., ability to define and articulate team deliverables) incl. towards senior leadership, a fluency in English is required, German is of advantage
  • 10% travel required

What you will be offered:

  • An opportunity to work in one of the world's most important pharmaceutical companies
  • Modern campus with plenty of green spaces and meeting areas
  • Central location in Basel
  • Varied job profile
  • Further training opportunities through temptraining
  • Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Diana Afonso.

Basel-Stadt Pharma Process industrialization MSAT Technology transfer TR Process Performance Qualification optimization CAPA validation

 

JETZT BEWERBEN