Drug Product MSAT Process Specialist 80-100% (m/f/d)

Beschreibung

As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Basel and Kaiseraugst, we are currently looking for a motivated and dedicated Drug Product MSAT Process Specialist for a temporary assignment of 10 month.

Drug Product MSAT Process Specialist is the first-line connector between PTT global MSAT and our 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 team

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

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card

Are you interested? Do not hesitate and submit your complete application documents online today. We look forward to hearing from you!