Section Lead Drug Product Process Engineering
Section Lead Drug Product Process Engineering
Section Lead Drug Product Process Engineering
Section Lead Drug Product Process Engineering
Roche
Pharmazeutische Produkte, Arzneimittel
Basel
Section Lead Drug Product Process Engineering
Über diesen Job
Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
As a Section Lead DP Process Engineering in Pharmaceutical Development in Basel, Switzerland, you are a member of the global Drug Product Process Engineering and Manufacturing team as part of the Department Biologics Pharmaceutical Development. The Department Biologics Pharmaceutical Development is responsible for the development of parenteral drug products (synthetic molecules and biologics) from Phase 1 up to Launch, including formulation and aseptic process development. The Pharmaceutical Development Process Engineer ensures robust clinical and commercial process designs for effective process validation and successful commercialization of sterile drug products.
This position is focused on robust process development for parenteral drug products to drive excellence and innovation and ensure seamless network-wide execution across biologics, synthetic molecules, and peptides.
The Opportunity:
In this role, you will lead a team of process engineers focused on developing sterile DP manufacturing processes across clinical and commercial stages. As part of the global team, you will ensure the implementation of harmonized, science- and risk-based strategies that enable efficient technology transfers and process validation in collaboration with internal and external manufacturing network partners. Furthermore, the Section Lead will foster a growth-oriented, high-performing team environment, enabling staff to develop their skills and contribute their best work.
- Provide technical oversight and strategic guidance for a team responsible for the development of robust manufacturing processes for parenteral liquid and lyophilized formulations including scale-up, process characterization & validation and transfer to global commercial manufacturing sites.
- Lead, coach and develop a team of approximately 8-12 process engineers focused on drug product process development across various modalities such as Biologics, synthetic molecules, peptides
- Ensure process designs for clinical and commercial stages are robust for effective validation and successful commercialization
- Represent the function during interactions with various interfaces and in stakeholder meetings, emphasizing global harmonization through collaboration, Lean principles, and an innovation mindset.
- Collaborate cross-functionally and with manufacturing sites, including partnerships with CMOs, to ensure alignment and successful project execution.
Who you are
- You hold a Ph.D. in relevant scientific or engineering disciplines (preferred) or have commensurate experience.
- You have at least 8 years of relevant experience in the biopharmaceutical industry and proven ability to shape and lead teams.
- You have experience in leading or managing groups of scientists and engineers, as well as working with departmental senior staff for project and people decisions.
- You demonstrate capabilities to lead, motivate, and develop people, focusing on optimum utilization of talent and skills.
- You possess strong technical expertise in parenteral process development and readiness to oversee end-to-end pharmaceutical development, including regulatory submissions
- You have a proven ability to prioritize resources effectively across the network and sponsor strategic process engineering projects, ensuring alignment and successful execution within complex organizational structures
- You are able to travel up to 20% domestically and internationally
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.