Senior electrical engineer állás, munka

• Management of deviations, change requests as well as corrective actions and preventive actions
• Review of equipment qualifications, batch documentation, and product release preparations for clinical studies

For our partner located in the canton of Bern, GI Life Sciences is looking for a: SENIOR SCIENTIST BIO-/CHEMICAL QUALITY CONTROL Start : Mid-November End : YOUR MISSION : As a SENIOR SCIENTIST IN BIO-/CHEMICAL QUALITY CONTROL, you will play a key role in establishing the BCQC unit within the...

• Start Date:or
• Latest Possible Start:
• Duration: 6 months initially; extension possible (e.g., additional 6 months)
• Location: Basel
• Workload: 100%
• Home Office: Yes
• Travel: Not expected
• Team Size: PCS safety team approx. 6; cross-functional project teamsmembers
• Hiring Manager: Simone Melega

Scientific & Strategic Leadership: Drive the overall scientific strategy & implementation, support study protocol development, ensure GCP and research quality, and serve as scientific spokesperson to authorities and partners. You will oversee planning and control of finances, timelines,...

• Design, develop, and optimize coagulation diagnostic assays and reagents
• Lead feasibility studies, verification, and validation activities in compliance with ISOand IVDR requirements
• Document all activities according to quality system procedures and design control standards

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• Develop and validate LC-MS methods for the quantification of impurities in complex samples
• Optimize and troubleshoot analytical methods to ensure accuracy, precision and robustness 
• Collaborate closely with cross-functional teams to drive project success

• Lead Scientific Discovery 
• Drive independent programs to identify novel plant species with untapped potential for PhytoComplex development 
• Establish innovative analytical methodologies for characterizing complex bioactive compounds using advanced techniques including chromatography and spectroscopy 

The Global Clinical Program Manager is a planning expert in Clinical Operations Program Leadership and is responsible for partnering with key stakeholders and CDMA (Clinical Development & Medical Affairs) functions to manage CDMA related project information to support decision making by: CDMA...

• Strategic Sourcing / CDMO Site Selections including Due Diligence
• Price Negotiation
• Contracting of CMO contracts
• SRM Activities for CMOs
• University degree a scientific or business field or similar
• Min. 5 years relevant experience CMO Management or procurement in CMO space 
• GMP Experience 

• Contribute to all phases of medical device development, from architecture concepts to design verification and design transfer
• Design and develop low-power medical embedded systems, with a strong focus on safety, reliability and regulatory compliance (IEC13485, IEC60601, ISOetc.)

• Lead, coach, and inspire a global team of Programme Managers - fostering collaboration, accountability, and continuous development
• Oversee customer account allocation and ensure balanced workload distribution and high-quality delivery across the team