Sr Principal Eng - Process Engineering
Hybrid · Schaffhausen, Schaffhausen, Switzerland
Job Summary
Lead the intake, scoping, prioritization, and resolution of synthetics controlled bioburden- drug product manufacturing related technical requests across global sites; lead early-phase process design and domain expertise for oral solid dose (OSD) products and bioavailability enhanced technologies (ASD, spray drying, SEDDS); ensure robust, fit-for-purpose process design while promoting standardization and platform approaches; provide input on key process, equipment, and technology decisions; collaborate with R&D, MSAT, Quality, EHS, and Operations; maintain connections with external networks to bring innovative DP manufacturing solutions; travel up to 25%; role requires a Master’s degree and 10+ years of relevant experience.
Required Qualifications
- Master’s degree or equivalent in Engineering, Pharmaceutical Sciences, or related technical field
- Minimum of 10 years of relevant experience in synthetics controlled bioburden drug product manufacturing, with emphasis on oral solid dose (OSD) processes and innovative technologies (e.g., semi-solid)
- Proven expertise in bioavailability enhanced technologies including amorphous solid dispersions (ASD) with deep knowledge of spray drying and SEDDS or similar alternative formulation approaches
- Experience with OSD controlled bioburden manufacturing, including batch and continuous manufacturing
- Strong understanding of cGMP environments and regulatory expectations for controlled bioburden-drug product manufacturing; aseptic capability is a plus
- Ability to lead multi-functional teams and influence technical decisions in a global organization
- Experience supporting early-phase design, detail design, startup processes and Commissioning & Qualification (C&Q) of controlled bioburden (and aseptic) equipment
- Willingness to travel up to 25% domestically and internationally
- Proficiency in written and spoken English
- Additional languages (Dutch, Spanish, Italian) AS an advantage
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