Senior technical support 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...

As a workflow manager within ZEISS Meditec AG, your role is similar to and in strong collaboration with product management for the single products contributing to your clinical workflow solution...

Develop and implement DSS cross-functional technology infrastructure strategy, ensuring alignment with business needs and stakeholder engagement, including Clinical Data Science, Data Engineering, Statistical Programming and Biostatistics...

• 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

Development of product strategies for existing and new portfolios, including market research to identify innovation opportunities in lens technology and design, as well as defining product specifications and managing the product lifecycle...

• Leading a high-performing team of analysts and the Country CFC Insights Lead
• Developing and implementing performance measurement, forecasting models, and omnichannel strategies
• Collaborating closely with Finance, Digital, CMO, and other cross-functional teams

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,...

• You are responsible for the overall PDC Presbyopia Program.
• You identify current barriers for surgeons to recommend PRESBYOND procedure.
• You will develop tools to facilitate PRESBYOND patient counseling.

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• 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.)

• Leading the development of the faculty's research strategy and building a strong interdisciplinary team.
• Establishing translational research projects within SFU MED and in collaboration with national and international partners.

• 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