Gi Group SA annunci per settore: Scienza e ricerca

For our client based in the canton of Berne, the Gi Life Sciences team is looking for : Temporary contract  Qualification and Validation Specialist Tasks : - Work closely with the Engineering and CQV teams - Ensure GMP compliant qualification activities - Participate in the assessment and management of problems in collaboration with other departments (Engineering and CVQ) - Participate in the continuous improvement of quality standards and problem management - Write validation protocols and reports - Review and approve C&Q/URS, RTM/QRA/IOC specific documentation as per standards - Review and assess project gaps if necessary   Profile : - Master's degree in biology, chemistry or equivalent - Minimum of 5 years' experience in qualification and validation in the pharmaceutical or biotechnology field - Experience in GMP, qualification, process validation and quality risk management - Commissioning experience on large scale projects - Fluent in English and German  - The spirit of analysis and synthesis - Agility, flexibility and adaptability    

For our partner Haleon located in Nyon, Gi Life Sciences is looking for a: QC Technician (1-year Temporary position)     Your mission:   Perform all QC testing end to end, from reception to final disposition before release on time by appropriate methods while respecting Good Manufacturing Practices.   Your responsibilities:   ·         Perform all QC testing end to end, from reception to final disposition before release, including management of external testing. ·         Perform double check of analytical tests to ensure the integrity of results. ·         Train other technicians to the QC analysis. ·         Suggest and implement Continuous Improvement actions in accordance with site objectives: EHS, Quality and cost. ·         Maintain 5S in the laboratory. ·         First level of equipment maintenance and troubleshooting. ·         Deal with deviations and laboratory investigation according to current laboratory SOPs. Implement CAPA in the laboratory. ·         Support or create SOPs and working documentation needed for QC laboratories (eg : equipment). ·         Respect all GMP standards to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies.   Your profile:   ·         3-5 years' experience in a Pharmaceutical Environment. ·         Proven process understanding (Pharma, GMP, investigation). ·         Continuous improvement experience (Lean, 5S). ·         Safety, Quality, Result and Customer oriented ·         Basic speaker (A2) English level ·         Team spirit, Open minded and Flexible

For our client in Wädenswil, we are looking for a motivated   Project Lead – Medicinal Chemistry   As a Medicinal Chemist you will play a vital role in the process of drug discovery, contributing in the creation of new anticancer agents. Using a range of chemistry techniques and collaborating with our computational biologist you will design and create new active pharmaceutical ingredients. You will work closely with other scientists within a project team to confirm the structures which you have synthesized and to understand and interpret biological testing of the compounds that you have created to see if they are effective.   Your tasks   - Plan and conduct scientific experiments in the lab to create and refine target molecules - Follow health and safety guidelines and safe working practices - Undertake data analysis to assess the results of experiments and the characteristics of the molecules produced - Ensure that structure and purity of compounds are correct - Collaborate closely with our computational biologist, analytical chemist and project teams to contribute towards the company's pipeline objectives - Contribute to the critical evaluation and selection of new targets - Publish science in high quality journals and publications - Give presentations on projects both at internal meetings and externally at conferences   Your qualifications   - PhD in synthetic organic chemistry or medicinal chemistry is required - Several years of industry experience in drug discovery across multiple projects - Excellent understanding of related scientific disciplines that are relevant to drug discovery and early development such as target validation, pharmacology, SBDD, ADME, large scale synthesis, structural biology, drug safety/toxicology - Record of publication in scientific reviewed journals and patents - State of the art organic synthesis knowledge, purification and analytical characterization including HPLC, MS and NMR - Able to work in a results driven environment with a strong customer focus, flexible to changing priorities and work within tight deadlines - Culturally sensitive, enjoy working in international teams and have a desire and willingness to expand the area of expertise - Excellent communication skills, both written and verbal in English and German Your application Please apply online. For further information about the position, please contact your Gi Consultant, Ms. Marta Castellano, MSc Biology (+41 76 342 57 90). Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton, BauTech and former Kelly Services. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 35 locations across Switzerland and over 250 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.  

For our partner in the Canton of Neuchâtel, Gi Life Sciences is looking for a:   Associate Director Quality Control   Your mission:   This position is accountable for the Quality Control activities at an OSD drug product manufacturing site, including method transfer / verification, analytical & microbiological testing of incoming materials, packaging components, in-process testing, drug product & drug substance release testing and stability testing, as well as equipment cleaning residual testing and support the manufacturing related area operation such as environment monitoring. You will ensure activities meet cGMP requirements and customers' expectations.   As the QC leader, you will be focused on the customers' needs. You will mentor and coach your team, creating a strong team spirit. Using your significant experience, you will streamline QC processes and implement efficiencies.   Duties: - Responsible for the project management to ensure on-time and high-quality execution of analytical activities, including method transfer / verification and all testing, in compliance with the site's Quality Management Systems (QMS) & cGMPs. - Accountable for meeting customers' expectations and needs. - Responsible for leading OOX results laboratory investigation and deviation investigation, perform impact assessment and establish corrective actions & preventive actions (CAPA) based on the root causes. - Accountable for optimizing QC processes, including procedures and daily operations to reduce lab errors and increase efficiency. - Accountable for overviewing the daily management of the Quality Control team (planning, communication, team organization, control & feedback). - Represent QC during client visits, audit and regulatory inspections as well as health authority audits. - Responsible for budget of the QC laboratory. - Act as a backup for the commercial release activities (paper or within the LIMS).     Your Profile: - University studies in chemistry, biochemistry, biology, or pharmacy or equivalent. - >10 years' experience in OSD QC laboratory management, CMO advantageous - Fluent in French and English. - Solid knowledge of analytical technologies and laboratory workflows, such as HPLC, dissolution, Karl-Fischer analysis, etc. - Knowledge of electronic data lifecycle management in the laboratory to ensure data reliability and integrity. - Familiar with method transfer and validation of drug products, material and product release as well as stability studies of drugs under different conditions. - Familiar with laboratory investigation and establishment of corrective and preventive measures. - Strong working knowledge to ensure quality control compliance with applicable regulations i.e. cGMP. - Organized and rigorous, able to provide leadership and coaching to the QC team in order to maintain an environment of trust and personal accountability. - Demonstrate ability to effectively communicate with the team and all levels of the organization. Work as a strong team partner in the site. - Ability to take decisions based on scientific risk assessment, to reduce and control the risk of late-stage commercialization project operations. - Able to manage, track and record budget.

The world leader in in-vitro diagnostics, Roche Diagnostics in Rotkreuz (ZG), is looking for an open-minded and proactive team player as   Scientist Lab Technician Assay Development (m/f/d)   The Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR technology in the areas of infectious diseases, genomics, and oncology, from early feasibility to commercial launch. Their main areas of responsibility include initial prototyping; optimization of assay design to meet product requirements and ensure manufacturability; development of test methods and acceptance criteria; transfer of reagent manufacturing instructions, test methods, and workflows to Operations; the design and execution of verification and validation activities, including guard-band studies, stability studies, and technical performance verification studies; and documentation of analytical performance for product labeling and regulatory submission packages. Throughout the product development phases, Assay Development interfaces with various departments including Research, Operations, Quality, Regulatory, and Business in order to create and realize what patients need next.   Your tasks - Performing root cause analysis as part of product care case handling - Working with high throughput lab-analyzer - Routine lab work with infectious samples and leading of own experiments including their analysis - Plan and execute different work packages for the development of molecular diagnostics test - Participation in project meetings and presentation of experimental data - Precise documentation of experiments using electronic lab journals according to GMP Standards - Equipment handling and maintenance - Statistical data analysis using different software and tools (e.g. JMP) - Author official documents (e.g. Design History Files) Your qualifications - Graduate as Biomedical Analyst Scientist (BMA HF) or apprenticeship as Lab Technician (Biology, Medical Diagnostics, Chemistry) or at least Bachelor or Master degree in Life Sciences with practical experience from the lab - Min. 2 years of professional lab experience with data analyses and biostatistics - Very good MS-Office and documentation skills - English fluency written and orally is a must - Open-minded team player - Strong analytical thinking to assess problems and develop solutions - Pro-active mindset and organized working style - Flexible, strategic thinking and self-dependent person Nice to have - Lab experience from a biotechnical environment with infectious sample handling Biosafety Level 2 - Experience in a GMP/GLP environment - German skills Your application Please apply online. For further information about the position, please contact your Gi consultant, Nicolas Keller, MSc Biochemistry (+41 76 471 68 09; nicolas.keller@gigroup.com).   Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton, BauTech and former Kelly Services. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 35 locations across Switzerland and over 250 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.