Principal Process Engineer, Technical Development

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The Position

As a Principal 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 Pharmaceutical Development Process Lead ensures robust clinical and commercial process designs for effective process validation and successful commercialization.

The Opportunity

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

• Develop, optimize, and validate robust processes for clinical and commercial parenteral drug products.
• Lead process design, validation studies, and technical transfers for seamless commercialization.
• This includes the development of freeze/thawing, mixing/compounding, filtration, filling and lyophilization processes, applying Quality by Design (QbD) principles where appropriate, and executing process characterization and validation programs.
• Design and execution of process characterization/process design studies as part of parenteral biologics, synthetic molecule and gene therapy drug product process development
• Collaborate cross-functionally and with manufacturing sites to ensure alignment and successful project execution, act as a single point of contact for DP Process Development.
• Foster innovation and continuous improvement in drug product and equipment processes.
• Support business and operational excellence by e.g. leading or contributing to structured Root Cause Analysis and Brainstorming exercises.
• Ensure compliance with regulatory standards.

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 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:

• Expertise in parenteral process development, technology transfers to commercial sites and regulatory submissions.
• Experience with implementing advanced Process Analytical Technologies and/or drug device combination product processes is a plus
• Excellent communication, project management, strategic thinking, and problem-solving skills.
• 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.