Global Head of Drug Product Process Engineering

at  Roche

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The Position
As part of Pharma Technical Development (PTD) our organization is committed to deliver the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development.
As an integrated partner within the drug development ecosystem, Global Biologics Pharmaceutical Development is dedicated to effectively developing innovative and patient-centered parenteral drug products including Formulation Development and Drug Delivery Systems

The Global Head of Drug Product Process Engineering will lead a team in developing pharmaceutical processing and technology for parenteral drug products within the Global Pharmaceutical Development Organization. Responsibilities include:

• Developing filling, lyophilization, and freeze/thaw processes
• Providing technical support for technical transfers between manufacturing sites
• Executing process characterization and validation programs
• Supporting equipment and processes related to these activitie

Primary responsibilities and accountabilities

• Leadership: The Global Head of Drug Product Process Engineering will lead and provide strategic guidance to a global team of process engineers and ensure that the Drug Product Process Engineering department embraces a spirit of continuous improvement and partnership with drug product manufacturing network staff. The incumbent will contribute to the strategic vision for Global Pharmaceutical Development as well as the company’s drug product manufacturing network, future capabilities and product development strategies. The leader will ensure prioritization and appropriate resource allocation for all projects within the Global Process Engineering function in accordance with the needs of project team milestones and manufacturing site needs. The incumbent will cultivate an organizational culture that is agile, lean, innovative and encourages smart risk taking by implementing new ways of working and empowering technical/project decision-making and will encourage development of staff - with strong focus on coaching, performance management and career development. The leader must be customer focused and have a strong commitment to embracing network talents and working collaboratively to advance Roche network capabilities and product portfolio. The leader will foster an environment of cross-functional collaboration, accountability, and technical rigor and will provide visible leadership in advancing new fill-finish technologies.
• Technical and Business Expertise: The Global Head of DP Process Engineering will oversee all activities related to sterile parenteral processing and technology development from preclinical through launch and marketed product support for both biologic and synthetic parenterals. The incumbent will represent the department during interactions with both internal and external interfaces and provide technical oversight for the generation and review of internal reports and regulatory submissions leveraging deep understanding of contemporary regulatory expectations (e.g., ICH, ISO), process characterization, validation and current QbD strategies. This role has accountability for implementing processes for individual molecule projects by providing subject matter resources, directing the development of novel processes/equipment and technologies, technical transfer of processes between sites, and for troubleshooting processes and equipment used in clinical and commercial manufacturing.
• Collaboration and Initiative: The incumbent will assess new areas and directions critical for the drug product manufacturing network and its long-term vision and success, the individual will work collaboratively to establish objectives, priorities, and direction for the department in alignment with network partners.
• Innovation, Internal and External Influence: The leader will foster innovation and ensure that the organization drives research and development for new and innovative pharmaceutical technologies (including formulation, process, delivery technologies). Enable the group to stay abreast of the latest advances in the field and produce significant documents or publications (internal or external) which support company priorities and sustains its scientific leadership. The incumbent will represent global PharmDev on key steering committees such the global manufacturing drug product technology teams, e.g. DPTC and TPC. Ideally the leader will be active in the peer community outside Roche through conferences and/or consortiums