Global MSAT DP Senior Process Steward

As part of Pharma Technical Operations (PT), Pharma Technical Technology (PTT) plays a key role in leading a seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization and scalable manufacturing processes and technologies in support of the manufacturing network. Product and process robustness, efficiency and reliability are key performance indicators, PTT owns and drives towards improvement.

Within PTT, Roche's global Manufacturing Science and Technology (gMSAT) department is the process and product owner for our commercial products, including our internal and external drug substance and drug product network, implementation of new technologies, network standardization, and mitigation of technical risks. The team is organized by product-focused Large Molecule and Small Molecule (DS & DP), Technology and Network Standards and Operations (Process Stewards, Tech Deployment, and Pilot Plant) teams and operates in cross-functional squads and circles.

The Process Steward [Small Molecule or Large Molecule] [DS or DP], reporting to the Process Steward Group Lead [Small Molecule or Large Molecule] [DS or DP]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-specific 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.

KEY RESPONSIBILITIES:

• Support Product Technical Leads and Product Stewards to ensure process industrialization (e.g. facility fit 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

Who you are

• Experience & Education: You have a B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline with 7+ 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

• Leadership: Collaborative, matrix team leadership experience and decision-making skills

• Technical Expertise: 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

• <10% travel required

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

Relocation benefits are available for this posting.

The expected salary range for this position based on the primary location of Oregon is $114,400 to $212,400 annually.Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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