Global Head of Drug Product Process Engineering

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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 Opportunity

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 activities

The role ensures robust clinical and commercial process designs for effective process validation and successful commercialization. Harmonizing work across technical development and PTO network partners is crucial for success.

The incumbent will collaborate with clinical and commercial sites to ensure seamless strategy deployment and right-first-time technology transfers, and provide support to commercial partners, ensuring successful supplies from CMOs to expedite market entry.

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.

Who you are

Education/Qualifications

- PhD in a relevant engineering/scientific field is or candidates with equivalent relevant work experience will also be considered, both with in-depth knowledge and experience in drug product parenteral process development and process validation

- 10+ years of experience in biopharmaceutical industry with significant familiarity with fill finish technology for sterile parenterals

Experience, Skills and Knowledge

- Strong leadership skills, with experience in managing multidisciplinary groups of scientists and engineers with at least 5 years of people management experience

- Experience as a member of departmental leadership teams and as an essential contributor to project and people decisions

- Strong technical expertise in pharmaceutical development, drug product processing technologies, and readiness to oversee end-to-end formulation development and associated regulatory agency submissions.

- Demonstrated ability to initiate, implement and manage change at an organizational level

- Excellent communication and collaboration skills, as well the ability to build and maintain productive relationships with other functional areas. Able to convey controversial information and decisions appropriately

- Excellent understanding of regulatory guidelines and industry practices

- Ability to think strategically and communicate complex technical topics to many levels and to encourage direct and open dialogues

- Demonstrated ability to drive continuous improvement, lead innovation and deliver results

Values, Leadership and Competencies

- Passionate for people development with a proven track record in recruiting and developing staff and and high performing teams

- Demonstrated leadership in managing international or global multi-disciplinary projects or initiatives, with a focus on aligning organizations and driving innovation

- Strategic thinking and problem-solving abilities, complemented by strong financial acumen and budget management experience.

- Embraces LEAN principles, VACC, the concepts of collective leadership and the six conditions of ownership

- Excellent communication and interpersonal skills, with proficiency in English

Other (e.g. Travel)

- National and international travel: up to 30%

Your application
Please upload your current resume and or apply with your updated Workday profile.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.