Klinikai kutató állások, munkák

• Plan and perform drug discovery contract research studies
• Executing bioassays
• Data evaluation and interpretation
• Prepare study reports in English
• Summarize data, analyze results and formulate conclusion
• Work with other project team members and communicate results with the team

• klinikai kutatásokban való részvétel
• dokumentáció vezetése és adatrögzítés
• folyamatos kapcsolattartás és együttműködés a kutatásban részt vevő betegekkel, orvosokkal és ápolókkal
• kutatással kapcsolatos betegdokumentáció pontos kezelése
• biológiai minták protokoll szerinti adminisztrációja

• laboratóriumi mérések készítése és új vizsgálatok elindítása
• kísérlethez kapcsolódó molekuláris mérések elvégzése
• kutatások megtervezése és kivitelezése
• részvétel a medikusok oktatásában

• Implement and validate state-of-the-art sequencing technologies (short-read and long-read) for diverse medical and scientific applications
• Establish and further develop an innovative metagenome sequencing platform for clinical diagnostics and hospital hygiene

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

You will be responsible for supporting the core and senior scientific leadership team by developing, maintaining, and executing programs and strategies across the business....

• A high-ownership role at the center of a lean program, with direct impact on key milestones.
• Close collaboration with senior scientific leadership and a network of top-tier external partners (Research Institute/CRO/CDMO/regulatory/quality).

• Start date:
• Latest Start Date:
• Planned duration: 6 months
• Extension: not likely (maternity leave)
• Max. Bill Rate: CHF (Depends on the experience)
• Workplace: Basel
• Workload: 100%
• Home Office: No
• Travel: No
• Team: 5-10 people
• Working hours: Standard

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

• Support validation activities for equipment, processes, and systems
• Assist in the preparation and execution of validation protocols (IQ/OQ/PQ)
• Review and maintain GMP documentation
• Collaborate with cross-functional teams such as Production, Quality Assurance, and Engineering

• Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
• Preparation, review, and approval of all relevant study documents in collaboration with external service providers

• Design and execute experiments for purification of recombinant proteins
• Analyze and interpret data to guide process development and troubleshooting
• Collaborate cross-functionally with other RnD teams
• Contribute scientifically to the project progress, lead project discussions and development

• Take full responsibility for the product portfolio throughout its entire lifecycle - from concept to phase-out
• Derive market and customer needs and translate them into clear product requirements and strategies

Management of projects from conception, development work, verification, manufacturing, validation and ultimately product commercialization, in accordance with Hygiena's Product Commercialization Process (PCP)....

Unterstützung innerhalb der F&E-Abteilung/Einführung neuer Produkte (Neuproduktentwicklung und Innovation) und anderer geschäftskritischer und/oder umsatzfördernder Maßnahmen von der Planung bis zur Kommerzialisierung...

Govern and steer the innovation pipeline, ensuring effective project management of all innovation initiatives in line with stage gate principles...

• Development new formulations: contribute to design of studies, perform experiments and prepare reports
• Develop analytical methods (e.g. HPLC)
• Prepare and characterize large number of formulations following DOE
• Assist in the development of methods to characterize formulations or raw materials

Collaborate closely with Translational Science Leads (TSL), Clinical Operations, Biostatistics/Bioinformatics, and Data Management teams to execute translational science strategies in clinical trials....

Develop and manage clinical project plan, timelines, and budgets end to end; clinical research, through pre-clinical evaluations, clinical trials and publications, to user guidelines and post-market evidence generation....

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain