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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.

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. 

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!

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