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The Position

As a Senior Process Engineer in Pharmaceutical Development, you are part of the Department “Pharmaceutical Development” in Pharma Technical Development (PTD) and member of the Process Engineering and Manufacturing group in Basel, Switzerland. The department Pharmaceutical Development is responsible for the development of parenteral drug products from Phase 1 up to Launch. Activities encompass formulation and aseptic manufacturing process development for parenteral drug products for all clinical stages and the market and the transfer of product and process to clinical and commercial manufacturing sites.

The Opportunity

Support of Pharmaceutical Development and the parenteral DP network with hands on and strategic support in the following activities:

• Design and execution of process characterization/process design studies as part of parenteral biologics, synthetic molecule and gene therapy drug product process development
• Develop in-depth knowledge of process unit operations of drug product manufacturing, establish and update guidance documents, act as a single point of contact and provide support during DP tech transfer activities
• Continuous Process / Equipment improvements of all relevant unit operations for the development and manufacturing of large and synthetic molecule parenterals (at Roche, CMOs & CDMOs) e.g. in CAPEX / Investment teams, equipment qualification teams, as User Team Lead or Process SPOC (incl. supporting sustainability goals)
• Support of establishment of new technologies of all relevant unit operations and/or container-closure components in development & commercial manufacturing in close collaboration with other functions involved
• Support business and operational excellence by e.g. leading or contributing to structured Root Cause Analysis and Brainstorming exercises.

Who you are

As the successful candidate you hold a Ph.D. or master degree in process engineering, pharmaceutical sciences, chemical process engineering or related fields and bring a minimum of 5 – 10 years of professional experience (industry) in process engineering / process development of DP manufacturing related fields of parenteral dosage forms for biologics, peptides and small molecules parenterals (including lyophilization / combination products). In addition you bring hands-on experience (i.e. active participation in related teams / responsible for the execution) of e.g:

• Parenterals product process improvement & scale up activities in above mentioned technologies and processes
• Experience in performing parenterals process equipment qualification activities and demonstrated ability to evaluate technical & Process engineering and SHE risks.
• Design / Justification of down-scale models incl. process parameters definition and characterization (User Requirements / Technical Specification)
• Troubleshooting activities & Root cause analysis (moderate and actively drive activities with multiple cross functional stakeholders)
• Good understanding of common technical standards, GMP, QbD and regulatory requirements of process validation and tech transfers and equipment design.
• Excellent communication skills and collaborative behaviors, as well as excellent stakeholder management skills in combination
• Willingness to travel internationally (up to 20%)

Are you passionate about Technical Development and parenteral DP, please apply!

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.

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