Section Lead Drug Product Process Engineering

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The 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

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.