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    • 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 (*****) 
    • basel, basel-stadt
    • contract
    For one of our clients in Basel we are looking for a Regulatory Scientist, Global Regulatory Affairs for a project until June 2022: Reason for opening: maternity leave cover Job Description: The Regulatory Scientist provides support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy. Key responsibilities include the following and may vary: 1. Input in development, post-approval and life cycle managemento Participate in global regulatory team meetings as appropriate;o Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;o Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.2. Liaison with Regulatory Agencies and Local Operating Companieso Act as back-up for contact with Regulatory Agencies as needed;o Draft cover letters for Regulatory Agency communication;o Assist in the preparation of meetings with Regulatory Agencies;o Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy.3. Input in process developmento Assist in development and improvement of processes related to regulatory submissions;4. Clinical Trialso Review clinical trial plans and protocols and ensure alignment with regulatory requirements;4.1. Health Authority Submissions (e.g. Briefing Books, Scientific advicepackages, Marketing Authorization Applications (MAAs), New DrugApplications (NDAs) or equivalent regional or national documents)o Provide regulatory support throughout registration process and life-cycle management;o Advise team in required documents and submission strategies (incollaboration with LOCs as appropriate)o Assist with timely availability of submission documents and ensure that all document components are in place on timeo Draft and review some document content (depending on level ofregulatory knowledge/expertise)o Prepare, hold and lead cross functional team meetings as appropriateo Understand submission details and liaise with Submission Managemento Review and approve submission planso Review of submission documents to ensure compliance with regulatoryrequirementso Assist with submission and acceptance of the submission packageo Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.4.2 Generalo Provide regulatory input for and appropriate follow-up to inspections,audits, litigation support and product complaints; o Serve as the Regulatory representative on specific multi-discipline teams;o Keep abreast of current and pending approvals in specific therapeuticareas and is knowledgeable of laws, guidances and requirements relatedto those areas. Principle responsibilities for the Regulatory Scientist, include: o Responsible to manage own capacity and assist visibility of capacity for their work group and for RSMO (5%)o Responsible for assigned projects to ensure strategic regulatory alignment across all functional areas. Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products. Provides regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate. Provides guidance and support to product development teams on regulatory issues.(65-75%)o Provide other general support on an as needed basis e.g. provide regulatory input and follow-up for inspections, audits, litigation support and products complaints (as appropriate) (20-30%) Qualifications Education & Experience:o University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience;o Minimum 5 years experience in regulatory affairs o Teamwork experience. Knowledge:o Understanding of the drug development process and regulatory submission and approval processo Knowledge of the regulatory environment, guidelines and practices of region Required Technical Competencies & Knowledge: o Regulatory Affairs competencies and proficiency levels vary based on role and level and may include: Applied Technical Knowledge, Busines Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing and Persuasive Communication.o Submissions Knowledge of regulatory requirements related to submissions and of filing registration process. Understands dossier component requirementso Ability to critically review and compile dossier componentso Understands submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR’s, renewal applicationso Knowledge of Microsoft programs as well as electronic management systems (e.g. ERIS, GRAIL) Regulatory Intelligenceo Understands competitive landscape, e.g., views of HA, regulatory precedence, labelling differences and therapeutic area issueso Up-to-date knowledge of current and pending approvals in specific therapeutic areas. Knowledge of laws, guidances and requirements and their implications related to specific therapeutic areaso Basic medical/scientific understanding in a clinical area Regulatory Strategyo Provide strategic input and technical guidance on regulatory requirements to development teamso Understands life cycle of drug product from discovery through marketing and post-approval requirementso Ability to interpret and apply local regulations and guidances to the life cycle of a drug producto Basic medical/scientific understanding of clinical trials and drug development Health Authority Expertiseo Knowledge of how Health Authorities operateso General knowledge of HA organizational structure and individual responsibilities in those structureso General knowledge of HA timelines for reviewing submissionso Organize and assist in executing HA meetings Big advantage: Experience in Pulmonary Hypertension / Orphan Diseases
    For one of our clients in Basel we are looking for a Regulatory Scientist, Global Regulatory Affairs for a project until June 2022: Reason for opening: maternity leave cover Job Description: The Regulatory Scientist provides support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy. Key responsibilities include the following and may vary: 1. Input in development, post-approval and life cycle managemento Participate in global regulatory team meetings as appropriate;o Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;o Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.2. Liaison with Regulatory Agencies and Local Operating Companieso Act as back-up for contact with Regulatory Agencies as needed;o Draft cover letters for Regulatory Agency communication;o Assist in the preparation of meetings with Regulatory Agencies;o Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy.3. Input in process developmento Assist in development and improvement of processes related to regulatory submissions;4. Clinical Trialso Review clinical trial plans and protocols and ensure alignment with regulatory requirements;4.1. Health Authority Submissions (e.g. Briefing Books, Scientific advicepackages, Marketing Authorization Applications (MAAs), New DrugApplications (NDAs) or equivalent regional or national documents)o Provide regulatory support throughout registration process and life-cycle management;o Advise team in required documents and submission strategies (incollaboration with LOCs as appropriate)o Assist with timely availability of submission documents and ensure that all document components are in place on timeo Draft and review some document content (depending on level ofregulatory knowledge/expertise)o Prepare, hold and lead cross functional team meetings as appropriateo Understand submission details and liaise with Submission Managemento Review and approve submission planso Review of submission documents to ensure compliance with regulatoryrequirementso Assist with submission and acceptance of the submission packageo Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.4.2 Generalo Provide regulatory input for and appropriate follow-up to inspections,audits, litigation support and product complaints; o Serve as the Regulatory representative on specific multi-discipline teams;o Keep abreast of current and pending approvals in specific therapeuticareas and is knowledgeable of laws, guidances and requirements relatedto those areas. Principle responsibilities for the Regulatory Scientist, include: o Responsible to manage own capacity and assist visibility of capacity for their work group and for RSMO (5%)o Responsible for assigned projects to ensure strategic regulatory alignment across all functional areas. Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products. Provides regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate. Provides guidance and support to product development teams on regulatory issues.(65-75%)o Provide other general support on an as needed basis e.g. provide regulatory input and follow-up for inspections, audits, litigation support and products complaints (as appropriate) (20-30%) Qualifications Education & Experience:o University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience;o Minimum 5 years experience in regulatory affairs o Teamwork experience. Knowledge:o Understanding of the drug development process and regulatory submission and approval processo Knowledge of the regulatory environment, guidelines and practices of region Required Technical Competencies & Knowledge: o Regulatory Affairs competencies and proficiency levels vary based on role and level and may include: Applied Technical Knowledge, Busines Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing and Persuasive Communication.o Submissions Knowledge of regulatory requirements related to submissions and of filing registration process. Understands dossier component requirementso Ability to critically review and compile dossier componentso Understands submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR’s, renewal applicationso Knowledge of Microsoft programs as well as electronic management systems (e.g. ERIS, GRAIL) Regulatory Intelligenceo Understands competitive landscape, e.g., views of HA, regulatory precedence, labelling differences and therapeutic area issueso Up-to-date knowledge of current and pending approvals in specific therapeutic areas. Knowledge of laws, guidances and requirements and their implications related to specific therapeutic areaso Basic medical/scientific understanding in a clinical area Regulatory Strategyo Provide strategic input and technical guidance on regulatory requirements to development teamso Understands life cycle of drug product from discovery through marketing and post-approval requirementso Ability to interpret and apply local regulations and guidances to the life cycle of a drug producto Basic medical/scientific understanding of clinical trials and drug development Health Authority Expertiseo Knowledge of how Health Authorities operateso General knowledge of HA organizational structure and individual responsibilities in those structureso General knowledge of HA timelines for reviewing submissionso Organize and assist in executing HA meetings Big advantage: Experience in Pulmonary Hypertension / Orphan Diseases
    • schlieren, zürich
    • permanent
    For our client, a growing startup in the biotech field, we are looking for a :Head of Clinical developmentLocation: SchlierenContract: Permanent Main objective:The primary role of the candidate will be to provide leadership and guidance for pipeline of clinical development programs. The candidate will be a member of the senior management team which determines and oversees R&D and sets the overall clinical strategic direction of the company. Your Main Responsibilities: For our portfolio of daughter companies - Direct the development of clinical strategies, and ensure the adherence to standard clinical practiceManage clinical aspects of regulatory strategies and interactions with Health Authorities for all our portfolio companiesOversee the analysis and interpretation of clinical trial data and the internal and external reporting of clinical trial resultsLead interactions with academic thought leaders, investigators, all other clinical stakeholders, and patient organizationsTake part in due diligence and communicate findings to the Business Development team on the clinical aspects of prospective new portfolio companiesProvide clinical support and work with other members of the management team to develop and communicate clinical aspects of the overall corporate strategyRepresent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partnersIn addition to leading and supervising the Clinical Research team the candidate will have direct line responsibility for the Clinical Operations and Medical Affairs responsible. As our portfolio grows, the candidate will be in charge of managing the expansion of the clinical team. Your profile:MD with Board Certification15+ years of experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugsMultiple years of management experience leading a clinical group including clinical/medical affairsKnowledge of relevant EMA and FDA regulations and guidelines as well as those of other major health authorities; experience in interactions with health authoritiesKnowledge of clinical research concepts, practices, and GCP and ICH GuidelinesExcellent communication skills in English and the ability to present the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor communityStrong enabling and coaching leadership mentalityAbility to engender credibility and confidence within and outside the company with an outstanding executive presenceAbility and strong desire to “make things happen”Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 30 % of work time Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    For our client, a growing startup in the biotech field, we are looking for a :Head of Clinical developmentLocation: SchlierenContract: Permanent Main objective:The primary role of the candidate will be to provide leadership and guidance for pipeline of clinical development programs. The candidate will be a member of the senior management team which determines and oversees R&D and sets the overall clinical strategic direction of the company. Your Main Responsibilities: For our portfolio of daughter companies - Direct the development of clinical strategies, and ensure the adherence to standard clinical practiceManage clinical aspects of regulatory strategies and interactions with Health Authorities for all our portfolio companiesOversee the analysis and interpretation of clinical trial data and the internal and external reporting of clinical trial resultsLead interactions with academic thought leaders, investigators, all other clinical stakeholders, and patient organizationsTake part in due diligence and communicate findings to the Business Development team on the clinical aspects of prospective new portfolio companiesProvide clinical support and work with other members of the management team to develop and communicate clinical aspects of the overall corporate strategyRepresent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partnersIn addition to leading and supervising the Clinical Research team the candidate will have direct line responsibility for the Clinical Operations and Medical Affairs responsible. As our portfolio grows, the candidate will be in charge of managing the expansion of the clinical team. Your profile:MD with Board Certification15+ years of experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugsMultiple years of management experience leading a clinical group including clinical/medical affairsKnowledge of relevant EMA and FDA regulations and guidelines as well as those of other major health authorities; experience in interactions with health authoritiesKnowledge of clinical research concepts, practices, and GCP and ICH GuidelinesExcellent communication skills in English and the ability to present the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor communityStrong enabling and coaching leadership mentalityAbility to engender credibility and confidence within and outside the company with an outstanding executive presenceAbility and strong desire to “make things happen”Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 30 % of work time Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    • 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) 
    • geneva, genève
    • permanent
    Do you have significant experience leading clinical operations? Do you enjoy working in a startup environment and are not afraid to lead and be hands on? Are you looking for your next challenge?In this case, you should have a look at this opportunity!Our client, a private biotechnology startup based in Geneva is looking for a:                                Clinical Operations Lead(Permanent position - to start ASAP)Your responsibilities:• Work in close relationship with the CEO & CMO to define the clinical development strategy in NMOSD & MG.• Lead the assigned clinical trials from start-up to closure.• Manage CROs and third party vendors contracted for the implementation of clinical studies.• Deliver clinical trials in agreed timeline & within budget.• Manage trial budget.• Participate in consultations with regulatory authorities.• Engage with & build productive relationship with KOL & investigatorsYour profile:Work experience:• At least 10 years of experience in clinical development Competencies & skills:• Track record of leading & delivering clinical studies• Excellent Project Management skills, including budgeting, timelines, issues and risk management• Experience with health authority interactions• Experience of working in an international environmentSmall company / start-up experience a plus• Experience with rare diseases a plus• Open minded team player• Hands-on problem solving attitude• Negotiation & clear and proactive communication skills• Independent, self motivated working style• Willingness to travelLanguages:•Fluent in English, both oral and writtenWe offer :• An exciting role with lots of possibility to shape and move your project • Startup spirit• Competitive compensation• Flexible working conditions• Workplace is flexible with focus on Geneva if you recognise yourself in this ad, don't wait any longer and apply now!
    Do you have significant experience leading clinical operations? Do you enjoy working in a startup environment and are not afraid to lead and be hands on? Are you looking for your next challenge?In this case, you should have a look at this opportunity!Our client, a private biotechnology startup based in Geneva is looking for a:                                Clinical Operations Lead(Permanent position - to start ASAP)Your responsibilities:• Work in close relationship with the CEO & CMO to define the clinical development strategy in NMOSD & MG.• Lead the assigned clinical trials from start-up to closure.• Manage CROs and third party vendors contracted for the implementation of clinical studies.• Deliver clinical trials in agreed timeline & within budget.• Manage trial budget.• Participate in consultations with regulatory authorities.• Engage with & build productive relationship with KOL & investigatorsYour profile:Work experience:• At least 10 years of experience in clinical development Competencies & skills:• Track record of leading & delivering clinical studies• Excellent Project Management skills, including budgeting, timelines, issues and risk management• Experience with health authority interactions• Experience of working in an international environmentSmall company / start-up experience a plus• Experience with rare diseases a plus• Open minded team player• Hands-on problem solving attitude• Negotiation & clear and proactive communication skills• Independent, self motivated working style• Willingness to travelLanguages:•Fluent in English, both oral and writtenWe offer :• An exciting role with lots of possibility to shape and move your project • Startup spirit• Competitive compensation• Flexible working conditions• Workplace is flexible with focus on Geneva if you recognise yourself in this ad, don't wait any longer and apply now!
    • basel, basel-stadt
    • contract
    For one of our clients in Basel we are looking for a Drug product lead in Biologics Pharmaceutical Development for a one year project. Job purpose To develop our growing pipeline of products we are looking for an experienced professional in the area of Late Phase Biologics Pharmaceutical Development. As a member of the team, you will play a key role in the development of formulation and processes for parenteral dosage forms for proteins for late phase clinical or commercial use. You will also be strongly involved in the generation of registration documents. Major accountabilities - Lead and co-ordinate the drug product team (functional experts) and represent Pharmaceutical Development on the CMC subteam. Fulfill all tasks and responsibilities related to own discipline.- Design, plan, perform and monitor all assigned drug product development activities applying state of the art technologies. Meet quality, quantity and timelines in all assigned projects.- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)- Interpret results, evaluate data, draw relevant conclusions, and write reports.- Generate scientific documents to hand over to internal partners (Manufacturing sites, Device Development, RegCMC, Clinics etc.).- Actively support generation of international registration documents for market authorization and interact with authorities where appropriate; act as technical expert in audits or inspections.- Contribute to overall development strategies and improvement of operational excellence of business processes.- Contribute to evaluation of new scientific technologies/equipment and proactively identify and realize opportunities for Invention Disclosures.- Represent pharmaceutical development in external collaborations.- Coach junior team members. Background • PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge.• Excellent English required (oral & written); good skills in German as site (local) language desired (oral)• Ideally 5-10 years relevant experience in pharmaceutical industry including thorough understanding of Pharmaceutical development activities for Biologics and/or process engineering of sterile dosage forms as well as a generally broad scientific and strategic background• Thorough track record of process transfer, validation and – importantly - regulatory submissions including health authority inspections.• In-depth background in commercial manufacturing and/or technical life cycle management of Biologics drug products is of advantage.• Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and productivity in projects 
    For one of our clients in Basel we are looking for a Drug product lead in Biologics Pharmaceutical Development for a one year project. Job purpose To develop our growing pipeline of products we are looking for an experienced professional in the area of Late Phase Biologics Pharmaceutical Development. As a member of the team, you will play a key role in the development of formulation and processes for parenteral dosage forms for proteins for late phase clinical or commercial use. You will also be strongly involved in the generation of registration documents. Major accountabilities - Lead and co-ordinate the drug product team (functional experts) and represent Pharmaceutical Development on the CMC subteam. Fulfill all tasks and responsibilities related to own discipline.- Design, plan, perform and monitor all assigned drug product development activities applying state of the art technologies. Meet quality, quantity and timelines in all assigned projects.- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)- Interpret results, evaluate data, draw relevant conclusions, and write reports.- Generate scientific documents to hand over to internal partners (Manufacturing sites, Device Development, RegCMC, Clinics etc.).- Actively support generation of international registration documents for market authorization and interact with authorities where appropriate; act as technical expert in audits or inspections.- Contribute to overall development strategies and improvement of operational excellence of business processes.- Contribute to evaluation of new scientific technologies/equipment and proactively identify and realize opportunities for Invention Disclosures.- Represent pharmaceutical development in external collaborations.- Coach junior team members. Background • PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge.• Excellent English required (oral & written); good skills in German as site (local) language desired (oral)• Ideally 5-10 years relevant experience in pharmaceutical industry including thorough understanding of Pharmaceutical development activities for Biologics and/or process engineering of sterile dosage forms as well as a generally broad scientific and strategic background• Thorough track record of process transfer, validation and – importantly - regulatory submissions including health authority inspections.• In-depth background in commercial manufacturing and/or technical life cycle management of Biologics drug products is of advantage.• Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and productivity in projects 
    • 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 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.
    • bulle, fribourg
    • temporary
    Vous avez une solide expérience en production biotechnologique ? Avez-vous de l'expérience dans le domaine des processus  USP et/ou DSP, et les procedures de déviations. Êtes-vous disponible immédiatement ou prochainement et à la recherche de votre prochain défi ? Dans ce cas, vous devriez jeter un coup d'œil à cette opportunité ! Notre client, une entreprise internationale de biotechnologie basée dans la région, est à la recherche d'un :  Process Support Specialist Immunology (contrat temporaire - 8 mois)Vos responsabilités : Effectuer la revue et l’interprétation en ligne des résultats de production. Le cas échéant, prendre les actions correctives immédiates et participer à la définition des plans d’actions à plus long terme en collaboration avec les équipes de production et autres Spécialistes si nécessaire ;Relever ou prendre en charge les points d’amélioration continue (au niveau sécurité, ergonomie et environnement, vitesse, quantité, pertes, rendement, matières premières et flux personnel) ;Rédiger les rapports de déviations ou remonter l’information pour que ce rapport soit rédigé dans le laps de temps imparti. Effectuer le suivi des déviations de leur émission à leur clôture ;Effectuer/participer aux investigations nécessaires et à leur documentation ;Guider ou participer aux analyses de risques nécessaires à la compliance ou aux projets ;Vérifier que les activités soient réalisées selon les procédures établies et dans le respect des règles de sécurité. Le cas échéant, corriger ou remonter les problèmes au Manager de la zone concernée ;Participer à une gestion efficace, solide et systématique du contrôle des changements ;Participer à la revue des dossiers de production dans les délais impartis si nécessaire ;Participer à la création et à la révision de la documentation relative au transfert de technologie en tant qu'expert en la matière ;Réaliser la Qualification de Performance (PQ) et la Qualification de Performance de Processus (PPQ) en collaboration avec le département Business Acceleration ;Réaliser les protocoles/rapports de vérification de nettoyage de routine ;Conduire les activités de change-over d’une campagne à une autre et prendre en charge la documentation associée ;Préparer, examiner et approuver les documents de CPV de routine ; participer au comité CPV ; Informer la hiérarchie de tout événement pouvant avoir un impact significatif sur le transfert et l'amélioration du processus ; Education : Diplome Scientifique : Bachelor, Master.Langues : Français suffisant, Anglais ou autre langue un plus. Expérience et compétences : Minimum 5 ans d'experience, dans une fonction similaire. Bonnes connaissances techniques générales en plus de l’expertise dans son domaine ;Capacité à soutenir une culture d'amélioration continue dans un site de fabrication ;Capacité à identifier et à mettre en œuvre les possibilités d'amélioration conformément à la vision, à la mission et à la stratégie (ascendante)Capacité à simplifier les processus, à réduire la variabilité et à éliminer les pertes pour produire des activités à plus forte valeur ajoutéeRédaction de rapports clairs et précis ;Excellente capacité en exécution de projet ;Faire preuve d'un esprit analytique ;Facilité à planifier, organiser, hiérarchiser et superviser plusieurs tâches en parallèle ;Capacité à anticiper les problèmes potentiels et à travailler au dépannage de manière coopérative ;Faire preuve d'esprit d'entreprise, de flexibilité et de polyvalence ;Etat d’esprit : proactif, capable de prendre des initiatives, autonome ;Capacité d’investigation sur différents types des problèmes (techniques, organisationnels, relationnels, etc.) ;Bonne communication générale. 
    Vous avez une solide expérience en production biotechnologique ? Avez-vous de l'expérience dans le domaine des processus  USP et/ou DSP, et les procedures de déviations. Êtes-vous disponible immédiatement ou prochainement et à la recherche de votre prochain défi ? Dans ce cas, vous devriez jeter un coup d'œil à cette opportunité ! Notre client, une entreprise internationale de biotechnologie basée dans la région, est à la recherche d'un :  Process Support Specialist Immunology (contrat temporaire - 8 mois)Vos responsabilités : Effectuer la revue et l’interprétation en ligne des résultats de production. Le cas échéant, prendre les actions correctives immédiates et participer à la définition des plans d’actions à plus long terme en collaboration avec les équipes de production et autres Spécialistes si nécessaire ;Relever ou prendre en charge les points d’amélioration continue (au niveau sécurité, ergonomie et environnement, vitesse, quantité, pertes, rendement, matières premières et flux personnel) ;Rédiger les rapports de déviations ou remonter l’information pour que ce rapport soit rédigé dans le laps de temps imparti. Effectuer le suivi des déviations de leur émission à leur clôture ;Effectuer/participer aux investigations nécessaires et à leur documentation ;Guider ou participer aux analyses de risques nécessaires à la compliance ou aux projets ;Vérifier que les activités soient réalisées selon les procédures établies et dans le respect des règles de sécurité. Le cas échéant, corriger ou remonter les problèmes au Manager de la zone concernée ;Participer à une gestion efficace, solide et systématique du contrôle des changements ;Participer à la revue des dossiers de production dans les délais impartis si nécessaire ;Participer à la création et à la révision de la documentation relative au transfert de technologie en tant qu'expert en la matière ;Réaliser la Qualification de Performance (PQ) et la Qualification de Performance de Processus (PPQ) en collaboration avec le département Business Acceleration ;Réaliser les protocoles/rapports de vérification de nettoyage de routine ;Conduire les activités de change-over d’une campagne à une autre et prendre en charge la documentation associée ;Préparer, examiner et approuver les documents de CPV de routine ; participer au comité CPV ; Informer la hiérarchie de tout événement pouvant avoir un impact significatif sur le transfert et l'amélioration du processus ; Education : Diplome Scientifique : Bachelor, Master.Langues : Français suffisant, Anglais ou autre langue un plus. Expérience et compétences : Minimum 5 ans d'experience, dans une fonction similaire. Bonnes connaissances techniques générales en plus de l’expertise dans son domaine ;Capacité à soutenir une culture d'amélioration continue dans un site de fabrication ;Capacité à identifier et à mettre en œuvre les possibilités d'amélioration conformément à la vision, à la mission et à la stratégie (ascendante)Capacité à simplifier les processus, à réduire la variabilité et à éliminer les pertes pour produire des activités à plus forte valeur ajoutéeRédaction de rapports clairs et précis ;Excellente capacité en exécution de projet ;Faire preuve d'un esprit analytique ;Facilité à planifier, organiser, hiérarchiser et superviser plusieurs tâches en parallèle ;Capacité à anticiper les problèmes potentiels et à travailler au dépannage de manière coopérative ;Faire preuve d'esprit d'entreprise, de flexibilité et de polyvalence ;Etat d’esprit : proactif, capable de prendre des initiatives, autonome ;Capacité d’investigation sur différents types des problèmes (techniques, organisationnels, relationnels, etc.) ;Bonne communication générale. 
    • lausanne, vaud
    • temporary
    Job descriptionThe candidate's mission is to assist the Clinical Manager in setting up, conducting and closing clinical studies in cooperation with all stakeholders. You will ensure the operational coordination of national and international clinical trials in compliance with regulations, deadlines and budget.Your Responsibilities: Arranging monitoring visits at appropriate time intervals and document according to SOPs,Arranging close-out visits with sites and organizing on-site or off-site archiving; document activities as per SOPs, standard operating procedure. Follow-up and resolve any issues arising from monitoring visits,Writing visit reports and filing and collating trial documentation and reports,Ensuring all unused trial supplies are accounted,Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV),Track completed CRFs sent to data management/locked EDC forms; track issued and resolved data queries.About youYour Profile:Medical related scientific degree (Bachelor, Master, Nursing qualifications or similar degrees and/or experience),1 year experience as a CRA, Clinical Research Associate, ideally in the medical device industry,Your background has allowed you to develop your technical knowledge in onco-surgery, histopathology. You demonstrate an excellent knowledge of the regulatory and ethical environment of Clinical Studies. Knowledge of the medical devices sector and strong scientific understanding,Experience Strong working knowledge and understanding of ICH-GCP, ISO14155, MDD / MDR, Swiss laws and regulations governing clinical trials, Excellent clinical trial monitoring skills with a high level of attention to detail and strong, organizational ability, excellent interpersonal skills and a good level of communication. A sense of responsibility and a spirit of initiative will be necessary qualities. Computer skills (MS Office) and experience in eCRF system for Clinical Research, CTMS Systems, as well as eTMF Software,English and French fluent written and spoken, German and Italian is a plus,Willingness to travel as required. We offer you:An autonomous position in an international context,A position rich in contacts and interaction,A different daily routine every day,You are joining a start-up company in full development.
    Job descriptionThe candidate's mission is to assist the Clinical Manager in setting up, conducting and closing clinical studies in cooperation with all stakeholders. You will ensure the operational coordination of national and international clinical trials in compliance with regulations, deadlines and budget.Your Responsibilities: Arranging monitoring visits at appropriate time intervals and document according to SOPs,Arranging close-out visits with sites and organizing on-site or off-site archiving; document activities as per SOPs, standard operating procedure. Follow-up and resolve any issues arising from monitoring visits,Writing visit reports and filing and collating trial documentation and reports,Ensuring all unused trial supplies are accounted,Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV),Track completed CRFs sent to data management/locked EDC forms; track issued and resolved data queries.About youYour Profile:Medical related scientific degree (Bachelor, Master, Nursing qualifications or similar degrees and/or experience),1 year experience as a CRA, Clinical Research Associate, ideally in the medical device industry,Your background has allowed you to develop your technical knowledge in onco-surgery, histopathology. You demonstrate an excellent knowledge of the regulatory and ethical environment of Clinical Studies. Knowledge of the medical devices sector and strong scientific understanding,Experience Strong working knowledge and understanding of ICH-GCP, ISO14155, MDD / MDR, Swiss laws and regulations governing clinical trials, Excellent clinical trial monitoring skills with a high level of attention to detail and strong, organizational ability, excellent interpersonal skills and a good level of communication. A sense of responsibility and a spirit of initiative will be necessary qualities. Computer skills (MS Office) and experience in eCRF system for Clinical Research, CTMS Systems, as well as eTMF Software,English and French fluent written and spoken, German and Italian is a plus,Willingness to travel as required. We offer you:An autonomous position in an international context,A position rich in contacts and interaction,A different daily routine every day,You are joining a start-up company in full development.
    • 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
    • eysin
    • temporary
    Are you an expert in mass spectrometry and characterization of monoclonal antibodies or proteins? Are you recognized for your analytical an organizational skills?Are you available immediately or soon and looking for your next challenging position?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 Scientist Mass Spectrometry(1 year temporary contract - to start ASAP) MAIN TASKS:Accountable to provide scientific and strategic expertise to CMC Development Teams in Mass Spectrometry.Responsible for mass spectrometry data generated in support of process and analytical teams.Develop platforms to perform:- LC-MS and LC-MS/MS routine testing techniques such as: Amino AcidSequencing, Post-Translational Modification Analysis, Intact Molecular Weight Analysis, Glycosylation Mapping, Disulfide Bonding Pattern Analysis, and Characterization and Semi-Quantification of Host Cell proteins.Develop reporting tools ensuring data traceability within the R&D IT infrastructure (use of eLN/LIMS, put in place and monitor SST for each LC-MS method, etc).Approve study plans, protocols and reports for work done internally.Propose and implement analytical outsourcing strategy, balancing opportunities and risks. Oversee work done in collaboration with CROs for process-related contaminants quantification.Keep abreast of technical development to maintain a state-of-the-art technology platform.Manage budget, resource allocation, and resource forecasting, and monitor and control expenditures against the department budget.Coordinate planning in MS laboratories to provide results and data interpretation to project teams.QUALIFICATION PROFILE:EDUCATION:Master’s degree in analytical biochemistry or equivalent studies. Bachelor's degree can be considered if 10 years of experience in mAbs and LC-MSWORK EXPERIENCE:At least three years of relevant experience in mass spectrometry and monoclonal antibodies.JOB SPECIFIC COMPETENCIES & SKILLS:Solid experience in mAb analytics in the pharma or biotech industry.Proven ability to support analytics for cell line and upstream/downstream process development.Entrepreneurial way of thinking.Ability to ensure and maintain a creative and highly motivating working atmosphere.Results orientation and strategic thinking.Excellent communication, presentation, and interpersonal skillsLANGUAGES:Fluency in English essential, both oral and written; French would be an assetif you recognize yourself in this ad, don't wait any longer and apply now!This ad was posted by Angèle, your Senior Recruiter from Randstad Geneva.Do you want to know more about her? Take a look at her video introduction by clicking here. 
    Are you an expert in mass spectrometry and characterization of monoclonal antibodies or proteins? Are you recognized for your analytical an organizational skills?Are you available immediately or soon and looking for your next challenging position?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 Scientist Mass Spectrometry(1 year temporary contract - to start ASAP) MAIN TASKS:Accountable to provide scientific and strategic expertise to CMC Development Teams in Mass Spectrometry.Responsible for mass spectrometry data generated in support of process and analytical teams.Develop platforms to perform:- LC-MS and LC-MS/MS routine testing techniques such as: Amino AcidSequencing, Post-Translational Modification Analysis, Intact Molecular Weight Analysis, Glycosylation Mapping, Disulfide Bonding Pattern Analysis, and Characterization and Semi-Quantification of Host Cell proteins.Develop reporting tools ensuring data traceability within the R&D IT infrastructure (use of eLN/LIMS, put in place and monitor SST for each LC-MS method, etc).Approve study plans, protocols and reports for work done internally.Propose and implement analytical outsourcing strategy, balancing opportunities and risks. Oversee work done in collaboration with CROs for process-related contaminants quantification.Keep abreast of technical development to maintain a state-of-the-art technology platform.Manage budget, resource allocation, and resource forecasting, and monitor and control expenditures against the department budget.Coordinate planning in MS laboratories to provide results and data interpretation to project teams.QUALIFICATION PROFILE:EDUCATION:Master’s degree in analytical biochemistry or equivalent studies. Bachelor's degree can be considered if 10 years of experience in mAbs and LC-MSWORK EXPERIENCE:At least three years of relevant experience in mass spectrometry and monoclonal antibodies.JOB SPECIFIC COMPETENCIES & SKILLS:Solid experience in mAb analytics in the pharma or biotech industry.Proven ability to support analytics for cell line and upstream/downstream process development.Entrepreneurial way of thinking.Ability to ensure and maintain a creative and highly motivating working atmosphere.Results orientation and strategic thinking.Excellent communication, presentation, and interpersonal skillsLANGUAGES:Fluency in English essential, both oral and written; French would be an assetif you recognize yourself in this ad, don't wait any longer and apply now!This ad was posted by Angèle, your Senior Recruiter from Randstad Geneva.Do you want to know more about her? Take a look at her video introduction by clicking here. 
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