Senior Scientist (PG26 / ST6) – Global Process Development, Drug Product Development and Delivery – Proteins organization, Schaffhausen, Switzerland
Primary Responsibilities
Act as program/project PD Lead and support the design of laboratory experiments in collaboration with project teams.
Use 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.
Develop a 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.
Develop and use lab‑based “scale-down” models to evaluate process parameters and ranges and build knowledge of “scale up” of unit operations to confirm or modify understanding of critical and key parameters.
Evaluate the suitability of manufacturing processes to existing product, process, and materials platforms and vice versa.
Work 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.
Qualifications
Opportunity to develop process engineering skills including the use of multi‑physics software for process modeling and the statistical analysis of data.
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.
Degree
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.
Physical Requirements / Working Conditions
Travel: 10‑30% – project dependent.
Required Skills
Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy.
Preferred Skills
Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy.
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