Senior Scientist Process

The candidate for this position will be responsible for process development of fill/finish manufacturing processes of biotherapeutic products. The candidate will also work and partner with colleagues in MSAT, Quality, Regulatory, and other functions to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations. Act as program/project PD Lead and Support the design of laboratory experiments in collaboration with project teams. Uses underlying physical, chemical, and biological principles to identify the mechanisms and kinetics governing process and product performance and scale up and achieve target process performance at all scales. Develops fundamental understanding of large molecule parenteral process unit operations on physical/chemical/biological product quality attributes, specifically freeze/thaw, mixing, filtration, filling process steps and PAT based experiments. Develops and uses lab based “scale-down” models to evaluate process parameters and ranges and builds knowledge of “scale up” of unit operations to confirm or modify understanding of critical and key parameters. Evaluates the suitability of manufacturing processes to existing product, process, and materials platforms and vice versa. Works with other development teams and commercial and clinical supply chain to conduct in depth reviews of process performance data to establish/refine and drive process improvements. Opportunity to develop process engineering skills including the use of multi-physics software for process modeling and the statistical analysis of data.

Johnson&Johnson;'s Innovative Medicine is recruiting for a Senior Scientist in the Global Process Development, Drug Product Development and Delivery – Proteins organization, located in Schaffhausen, Switzerland. At the Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

• Demonstrated competency and experience in biologics drug product development within the biopharmaceutical industry is required.

• Must have knowledge of drug substance and/or drug product process.

• Knowledge and applied experience of biopharmaceutical process design, technology transfer and drug product fill/finish operations is a must.

• Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices is preferred.

• Proven track record of creativity and problem solving.

• Ability to collaborate with cross functional teams is a must.

• Excellent oral and written language skills in German and/or English.

• Motivated, self-starter able to work independently with demonstrated problem-solving skills.

• Master Degree in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 3 years of experience OR a PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with up to 3 years of experience is required.