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    • genève, genève
    • contract
    Do you have a significant experience in biostatistics?Are you knowledgeable in clinical trials and regulatory requirements? Are you recognized for your organizational skills? Are you available immediately or soon and looking for your next challenge?In this case, you should have a look at this opportunity! Our client, an international biotechnology industry based in the Geneva area, is looking for a: Senior Manager Biostatistics (temporary contract - 5 months with possible extension) Main Tasks:Contribute to the development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission package, interactions with Health AuthoritiesLead or responsible for the oversight of Statistical Analyses Plans and other statistical deliverables.For projects under direct responsibility:o provide input for detailed timelines forecasting for biostatistics related deliverables.o Actively contribute to cost tracking related to the functional deliverableso biostatistics representative for audits and inspectionsManage and troubleshoot operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues according to the level of expertise.Effectively collaborate with Biostatistics, Programming and Data Management colleagues as well as with Pharmacometrician for input and information exchange to facilitate best practices across all studies/programs.Participate in CRO selection process and provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.Provide input to process improvement: assess new methodologies or technologies when applicable; contribute to the development, review and update of BDM SOPs as company/situations evolve.Collaborate effectively with cross-functional teams and external partners.Maintain strong and broad based statistical expertise. Required Profile: Education: Master’s degree (or equivalent) or PhD in Statistics, Biostatistics or related Discipline Work experience:10+ years of related industry experience within the functional area.Strong SAS expertise Job Specific Competencies & Skills: Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective.Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)Strong communication skills; verbal, written, and presentation.Highly motivated and enjoys working in a fast-paced environment.Strong organizational skills and the ability to prioritize and multi-task.Positive, flexible self-starter who thrives under pressure. Languages:English fluent If you recognize yourself in this ad, don't wait any longer and apply now!  
    Do you have a significant experience in biostatistics?Are you knowledgeable in clinical trials and regulatory requirements? Are you recognized for your organizational skills? Are you available immediately or soon and looking for your next challenge?In this case, you should have a look at this opportunity! Our client, an international biotechnology industry based in the Geneva area, is looking for a: Senior Manager Biostatistics (temporary contract - 5 months with possible extension) Main Tasks:Contribute to the development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission package, interactions with Health AuthoritiesLead or responsible for the oversight of Statistical Analyses Plans and other statistical deliverables.For projects under direct responsibility:o provide input for detailed timelines forecasting for biostatistics related deliverables.o Actively contribute to cost tracking related to the functional deliverableso biostatistics representative for audits and inspectionsManage and troubleshoot operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues according to the level of expertise.Effectively collaborate with Biostatistics, Programming and Data Management colleagues as well as with Pharmacometrician for input and information exchange to facilitate best practices across all studies/programs.Participate in CRO selection process and provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.Provide input to process improvement: assess new methodologies or technologies when applicable; contribute to the development, review and update of BDM SOPs as company/situations evolve.Collaborate effectively with cross-functional teams and external partners.Maintain strong and broad based statistical expertise. Required Profile: Education: Master’s degree (or equivalent) or PhD in Statistics, Biostatistics or related Discipline Work experience:10+ years of related industry experience within the functional area.Strong SAS expertise Job Specific Competencies & Skills: Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective.Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)Strong communication skills; verbal, written, and presentation.Highly motivated and enjoys working in a fast-paced environment.Strong organizational skills and the ability to prioritize and multi-task.Positive, flexible self-starter who thrives under pressure. Languages:English fluent If you recognize yourself in this ad, don't wait any longer and apply now!  
    • basel, basel-stadt
    • contract
    For our client, a pharmaceutical company in Basel we are looking for aClinical Trial LeaderStart date: asapEnd date: 31.12.2022Extension: possibleWork location: BaselWorkload: 100%Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).Tasks & Responsibilities:Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be de- pendent on department workload and need).Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practicesAuthor of the clinical study protocol and other study essential documents.Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high-quality data are transferred/available in a timely manner.Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure the report is completed according to current requirement. Responsible for report publication.In collaboration with the Medical Expert and CTT, coordinate the ongoing medical/scientific review of the clinical trial data (as needed), and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.Ensure a complete review is conducted of all study documentation within the assigned studies/project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.Oversee the work of assigned support CTL(s), ensuring clear delegation/assignment of duties are documented.Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.Must-haves:BSc or MSc in life sciences or nursing; a Ph.D. level scientist with life sciences background; PharmD or equivalent qualification or work experience.Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi-national environment using different models for trial execution).Demonstrated leadership and problem-solving skills.Track record of managing multiple, complex clinical trials.Capable of clear written and verbal expression of ideas, an active/proactive communicator.Ability to interact with a wide range of people and build strong positive relationships.Potential for customer orientation awareness and focus.Excellent organizational skills and interpersonal skills.Ability to work independently and in a team environment managing multiple priorities.
    For our client, a pharmaceutical company in Basel we are looking for aClinical Trial LeaderStart date: asapEnd date: 31.12.2022Extension: possibleWork location: BaselWorkload: 100%Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).Tasks & Responsibilities:Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be de- pendent on department workload and need).Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practicesAuthor of the clinical study protocol and other study essential documents.Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high-quality data are transferred/available in a timely manner.Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure the report is completed according to current requirement. Responsible for report publication.In collaboration with the Medical Expert and CTT, coordinate the ongoing medical/scientific review of the clinical trial data (as needed), and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.Ensure a complete review is conducted of all study documentation within the assigned studies/project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.Oversee the work of assigned support CTL(s), ensuring clear delegation/assignment of duties are documented.Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.Must-haves:BSc or MSc in life sciences or nursing; a Ph.D. level scientist with life sciences background; PharmD or equivalent qualification or work experience.Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi-national environment using different models for trial execution).Demonstrated leadership and problem-solving skills.Track record of managing multiple, complex clinical trials.Capable of clear written and verbal expression of ideas, an active/proactive communicator.Ability to interact with a wide range of people and build strong positive relationships.Potential for customer orientation awareness and focus.Excellent organizational skills and interpersonal skills.Ability to work independently and in a team environment managing multiple priorities.
    • lausanne, vaud
    • permanent
    Position of Medical Director (Permanent Contract) LausanneFor our client, a Swiss innovative medical device company based in Lausanne, developing and manufacturing a breakthrough imaging solution with the potential to improve patient care and cancer surgery outcome. Offering real-time ability to identify cancerous tissues and react immediately, this new visualisation modality holds the promise for a broad range of surgical and diagnostic applicationsResponsabilities :Reporting directly to the CEO, the Medical Director has the responsibility to support the Medical affairs needs. In this role, the Medical Director will partner closely with other teams to work with leadership to align and prioritize project work. - Design and develop clinical plans and protocol- Deliver and execute the clinical development plans- Develop a Medical Affairs Strategic Plan for Europe and US- Act as primary contact- Coordinate cross functional areas- Serve as Medical Expert- Document owner (or significant contributor) for Clinical Study Report- Presentation and Publication of Clinical Study Results- Provide clinical leadership and medical strategic input- Drive execution of the clinical program- Organisational Development and Compliance- Helps facilitate engagement with key subject matter experts- Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders in alignment with customer needs and medical strategy.- Identify and engage international, national, and regional thought leaders- Participate in key external events- Keeps abreast of trends in health careQualifications : - Medical Degree (M.D., D.O. or equivalent) with a strong background in clinical trial management, scientific investigation and proven ability to interpret scientific and study data required.- Professional experience - 10-15 years experience in the Medical device industry in a similar position. Global exposure and expertise in US & Europe.- Expertise in strategic aspects related to marketing needs (reimbursement, regulatory pathway)- Influencing Skills - Able to establish rapport, value and respect within a team, as well as with KOLs and other influential stakeholders, externally.- Interpersonal Skills - Strong personal credibility, written and oral communication skills.- Leadership Skills : Team orientated with the confidence, maturity and integrity to lead effectively.- Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature clinical and business judgement in making decisions.- Travel : This position may require some U.S. and european travel. Ability to travel domestically and internationally- Languages - Fluent in French and English; ability to speak, read, and write. Must be able to communicate clearly and accurately. Multiple languages is a plus- Regulations knowledge - Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent. Prefered qualifications: Expertise in oncology; breast cancer and prostate in particular.Professional relationships with an established network of oncologists and surgeons.
    Position of Medical Director (Permanent Contract) LausanneFor our client, a Swiss innovative medical device company based in Lausanne, developing and manufacturing a breakthrough imaging solution with the potential to improve patient care and cancer surgery outcome. Offering real-time ability to identify cancerous tissues and react immediately, this new visualisation modality holds the promise for a broad range of surgical and diagnostic applicationsResponsabilities :Reporting directly to the CEO, the Medical Director has the responsibility to support the Medical affairs needs. In this role, the Medical Director will partner closely with other teams to work with leadership to align and prioritize project work. - Design and develop clinical plans and protocol- Deliver and execute the clinical development plans- Develop a Medical Affairs Strategic Plan for Europe and US- Act as primary contact- Coordinate cross functional areas- Serve as Medical Expert- Document owner (or significant contributor) for Clinical Study Report- Presentation and Publication of Clinical Study Results- Provide clinical leadership and medical strategic input- Drive execution of the clinical program- Organisational Development and Compliance- Helps facilitate engagement with key subject matter experts- Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders in alignment with customer needs and medical strategy.- Identify and engage international, national, and regional thought leaders- Participate in key external events- Keeps abreast of trends in health careQualifications : - Medical Degree (M.D., D.O. or equivalent) with a strong background in clinical trial management, scientific investigation and proven ability to interpret scientific and study data required.- Professional experience - 10-15 years experience in the Medical device industry in a similar position. Global exposure and expertise in US & Europe.- Expertise in strategic aspects related to marketing needs (reimbursement, regulatory pathway)- Influencing Skills - Able to establish rapport, value and respect within a team, as well as with KOLs and other influential stakeholders, externally.- Interpersonal Skills - Strong personal credibility, written and oral communication skills.- Leadership Skills : Team orientated with the confidence, maturity and integrity to lead effectively.- Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature clinical and business judgement in making decisions.- Travel : This position may require some U.S. and european travel. Ability to travel domestically and internationally- Languages - Fluent in French and English; ability to speak, read, and write. Must be able to communicate clearly and accurately. Multiple languages is a plus- Regulations knowledge - Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent. Prefered qualifications: Expertise in oncology; breast cancer and prostate in particular.Professional relationships with an established network of oncologists and surgeons.
    • basel, basel-stadt
    • contract
    For one big pharmaceutical company in Basel we are looking for a Bioanalytical Manager Small Molecules for a 18 months contract. Background:As part of the Pharma Research and Early Development organisation in Basel, the department of Bioanalytical R&D, within the unit Pharmaceutical Sciences is responsible for characterising and profiling new pharmaceutical compounds in pre-clinical and clinical development. The group of Regulated Bioanalysis acts as an interface for the conduct of bioanalytical development projects in cooperation with internal pre-clinical and clinical stakeholders, external contract research organizations (CROs) and health authorities. The successful candidate will interact with external CROs and internal project teams for conducting small molecules bioanalytical work according to regulatory guidance. He/she will manage full bioanalytical support for the assigned multiple projects by providing support to internal project teams and directing bioanalytical work at CROs. Perfect Candidate:The perfect candidate is someone who had a similar position in bioanalysis previously within a pharma (preferred) or a CRO or an experienced scientist with experience with small molecule bioanalysis very keen to learn and with a positive attitude. Please note the preference goes to the first profile (experience in pharma/CRO). The successful candidate will have an education within chemistry/ biology / biochemistry. This is a contract with potential internal opportunity afterwards.Please note onsite work will be required. The specifics (days onsite vs home office) will be discussed with the manager. Please note remote work is not an option and we expect candidates to be able to be onsite.  General Information:• Start date: ASAP• Latest start date: 3 months’ notice is acceptable• End date: 18 months contract• Extension: possible• Work location: Basel• Workload: 100%• Remote/Home Office: Onsite work will be required.• Travelling: No Tasks & Responsibilities:• Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needs.• Responsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.• Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for development compounds (drugs) and any concomitant/interaction compound in the given project.• Manage and direct analysis of samples and timelines from preclinical and clinical studies for the project at CRO labs.• Participate actively in expert teams; act as primary contact person for DMPK and clinical project leaders.• Interact proactively with the assay development team.• Ensure full compliance with the current global and local bioanalytical guidance and GxP.• Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical sciences. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that the most advanced and most efficient procedures are used.• Provide technical leadership in issue resolution.• Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.• Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.• Maintain open links with other disciplines within the department and the organization.• Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issues. Must haves:• Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis (first option preferred and will receive 5 stars) (*****)• Excellent work experience on small molecule bioanalysis (*****)• Strong vendor management experience, looking after outsourced studies to external CROs (*****)• Degree in chemistry/ biology/ biochemistry (*****) 
    For one big pharmaceutical company in Basel we are looking for a Bioanalytical Manager Small Molecules for a 18 months contract. Background:As part of the Pharma Research and Early Development organisation in Basel, the department of Bioanalytical R&D, within the unit Pharmaceutical Sciences is responsible for characterising and profiling new pharmaceutical compounds in pre-clinical and clinical development. The group of Regulated Bioanalysis acts as an interface for the conduct of bioanalytical development projects in cooperation with internal pre-clinical and clinical stakeholders, external contract research organizations (CROs) and health authorities. The successful candidate will interact with external CROs and internal project teams for conducting small molecules bioanalytical work according to regulatory guidance. He/she will manage full bioanalytical support for the assigned multiple projects by providing support to internal project teams and directing bioanalytical work at CROs. Perfect Candidate:The perfect candidate is someone who had a similar position in bioanalysis previously within a pharma (preferred) or a CRO or an experienced scientist with experience with small molecule bioanalysis very keen to learn and with a positive attitude. Please note the preference goes to the first profile (experience in pharma/CRO). The successful candidate will have an education within chemistry/ biology / biochemistry. This is a contract with potential internal opportunity afterwards.Please note onsite work will be required. The specifics (days onsite vs home office) will be discussed with the manager. Please note remote work is not an option and we expect candidates to be able to be onsite.  General Information:• Start date: ASAP• Latest start date: 3 months’ notice is acceptable• End date: 18 months contract• Extension: possible• Work location: Basel• Workload: 100%• Remote/Home Office: Onsite work will be required.• Travelling: No Tasks & Responsibilities:• Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needs.• Responsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.• Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for development compounds (drugs) and any concomitant/interaction compound in the given project.• Manage and direct analysis of samples and timelines from preclinical and clinical studies for the project at CRO labs.• Participate actively in expert teams; act as primary contact person for DMPK and clinical project leaders.• Interact proactively with the assay development team.• Ensure full compliance with the current global and local bioanalytical guidance and GxP.• Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical sciences. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that the most advanced and most efficient procedures are used.• Provide technical leadership in issue resolution.• Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.• Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.• Maintain open links with other disciplines within the department and the organization.• Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issues. Must haves:• Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis (first option preferred and will receive 5 stars) (*****)• Excellent work experience on small molecule bioanalysis (*****)• Strong vendor management experience, looking after outsourced studies to external CROs (*****)• Degree in chemistry/ biology/ biochemistry (*****) 
    • bern, bern
    • permanent
    Du möchtest dich weiterentwickeln und bringst schon eine erste erfolgreiche Berufserfahrung als Chemielaborant/in mit?Für unseren Kunden, ein führendes Unternehmen im Nahrungsmittelbereich, suchen wir ab sofort nach einem                           Laborant/in Chemie (EFZ)Im Berner GrossraumUnbefristeter VertragAufgaben und Verantwortungsbereiche:Durchführung chemischer und physikalischer Analysen zur Unterstützung der Forschung mit den Schwerpunkten Pulvereigenschaften und Mikroskopie sowie Mithilfe in den chemischen Labors (zum Beispiel Proteinanalysen)Enge Zusammenarbeit mit den Teams von Produktentwicklung und Forschung sowie Präsentation und Diskussionen von ResultatenEinhaltung der Regeln für Qualität und Sicherheit (lokale Instruktionen, GLP)Mithilfe bei der Einführung und Validierung neuer analytischer Methoden Berufliche Anforderungen:Du hast eine abgeschlossene Berufsbildung als Laborant/in EFZ ChemieDu verfügst über gute analytische Kenntnisse Du hast idealerweise schon eine erste Erfahrungen in der Lebensmittelbranche Berufsbildnerkurs von Vorteil Persönliche Anforderungen:Du bist kommunikativ & ein team playerDu verfügst über eine selbständige Arbeitsweise und gute Fähigkeiten zur Arbeit in einem internationalen TeamDu hast gute Deutsch- und Englischkenntnisse (mündlich und schriftlich) 
    Du möchtest dich weiterentwickeln und bringst schon eine erste erfolgreiche Berufserfahrung als Chemielaborant/in mit?Für unseren Kunden, ein führendes Unternehmen im Nahrungsmittelbereich, suchen wir ab sofort nach einem                           Laborant/in Chemie (EFZ)Im Berner GrossraumUnbefristeter VertragAufgaben und Verantwortungsbereiche:Durchführung chemischer und physikalischer Analysen zur Unterstützung der Forschung mit den Schwerpunkten Pulvereigenschaften und Mikroskopie sowie Mithilfe in den chemischen Labors (zum Beispiel Proteinanalysen)Enge Zusammenarbeit mit den Teams von Produktentwicklung und Forschung sowie Präsentation und Diskussionen von ResultatenEinhaltung der Regeln für Qualität und Sicherheit (lokale Instruktionen, GLP)Mithilfe bei der Einführung und Validierung neuer analytischer Methoden Berufliche Anforderungen:Du hast eine abgeschlossene Berufsbildung als Laborant/in EFZ ChemieDu verfügst über gute analytische Kenntnisse Du hast idealerweise schon eine erste Erfahrungen in der Lebensmittelbranche Berufsbildnerkurs von Vorteil Persönliche Anforderungen:Du bist kommunikativ & ein team playerDu verfügst über eine selbständige Arbeitsweise und gute Fähigkeiten zur Arbeit in einem internationalen TeamDu hast gute Deutsch- und Englischkenntnisse (mündlich und schriftlich) 
    • basel, basel-stadt
    • contract
    For our client, a pharmaceutical company in the Basel area we are looking for anBioanalytical Manager Start date: middle May 2021, latest August 2021End date:18 monthsExtension: possibleWork location: BaselRemote/Home Office: home office at the momentBackground:This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This will be on both small and large molecules.Tasks & Responsibilities:Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needsResponsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.Participate actively in PS subteams, act as primary contact person for DMPK project leader.Act as Bioanalytical Leader when required. Interact proactively with the assay development team.Ensure full compliance with the current global and local bioanalytical guidance and GxPs.Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.Provide technical leadership in issue resolution.Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.Maintain open links with other disciplines within the department and the organization.Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issuesMust haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysisExcellent work experience on both large and small molecules bioanalysis (preferred and will receive 5 stars) IF not both, either large or smallStrong vendor management experience, looking after outsourced studies to external CROs (*****)Degree in biology/biochemistry (*****)
    For our client, a pharmaceutical company in the Basel area we are looking for anBioanalytical Manager Start date: middle May 2021, latest August 2021End date:18 monthsExtension: possibleWork location: BaselRemote/Home Office: home office at the momentBackground:This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This will be on both small and large molecules.Tasks & Responsibilities:Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needsResponsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.Participate actively in PS subteams, act as primary contact person for DMPK project leader.Act as Bioanalytical Leader when required. Interact proactively with the assay development team.Ensure full compliance with the current global and local bioanalytical guidance and GxPs.Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.Provide technical leadership in issue resolution.Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.Maintain open links with other disciplines within the department and the organization.Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issuesMust haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysisExcellent work experience on both large and small molecules bioanalysis (preferred and will receive 5 stars) IF not both, either large or smallStrong vendor management experience, looking after outsourced studies to external CROs (*****)Degree in biology/biochemistry (*****)
    • luterbach, solothurn
    • contract
    For our biotech client in Solothurn we are looking for aManufacturing Associate IIIContract: until 31.03.2022 Tasks:Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentationPerform troubleshooting/investigation of equipment and process issuesRevises documents as instructed, Capable of equipment and/or process changesActively participates in training activities, managing their individual training plan.  Trains other associates as required.Executes validation protocolsCapable of leading shift when supervisor is absent, and actively leads or participates in shift exchanges.  Coordinates activities and daily schedules with cross-functional areas.And other job duties that may be assigned from time to time.Qualifications:Relevant education from chemical industry, food industry, pharmaceutical or biotech industry.basic knowledge of biopharmaceutical technology and processessolid understanding of the requirements within correct and timely documentation within a cGMP environmentknowledge in all operational and regulatory procedures of manufacturing department
    For our biotech client in Solothurn we are looking for aManufacturing Associate IIIContract: until 31.03.2022 Tasks:Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the recipe & MFG documentationPerform troubleshooting/investigation of equipment and process issuesRevises documents as instructed, Capable of equipment and/or process changesActively participates in training activities, managing their individual training plan.  Trains other associates as required.Executes validation protocolsCapable of leading shift when supervisor is absent, and actively leads or participates in shift exchanges.  Coordinates activities and daily schedules with cross-functional areas.And other job duties that may be assigned from time to time.Qualifications:Relevant education from chemical industry, food industry, pharmaceutical or biotech industry.basic knowledge of biopharmaceutical technology and processessolid understanding of the requirements within correct and timely documentation within a cGMP environmentknowledge in all operational and regulatory procedures of manufacturing department

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