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5 jobs found for biotechnology pharmaceutical

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    • basel, basel-stadt
    • temporary
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Manager, Manufacturing Project Management Location:BaselContract: Temporary for 6 monthsIn this role, the Manager, Project Management will develop strong oversight and governance mechanisms for various work streams as the international organization is set up and scales up operations. These work streams include international CMO startup, Fill/Finish capacity ramp up, Logistics and Supply Chain setup and integration with Global processes, Quality Assurance and control setup, regulatory requirement compliance, people & organization ramp up, and setup of the Finance support infrastructure Your Responsibilities: Establish, manage and lead cross-functional project teamsRepresent this project and other project sponsors for accelerated scale up of international manufacturingCreate and maintain detailed project plans to ensure clarity of deliverables and timingTrack project tasks and efforts associated with organization and process setup of multiple functions e.g. Manufacturing, Tech Transfer, Supply Chain, Logistics, Quality, Regulatory, FinanceCoordinate scheduling and facilitating meetings, sending out agendas, writing and distributing minutes, managing team documentation, and tracking goals and action items Your profile:Education: University degree in an appropriate discipline (e.g. sciences, engineering, business)Experience: 8+ years in Pharmaceutical/Biotechnology DevelopmentThe successful candidate will have demonstrated experience in leading cross-functional development programs in both early (i.e. Phase 1/IND) and late stage (Phase 3/BLA)Ability to work in a fluid environment and foster a strong collaborative spiritAbility to negotiate and sustain networking relationshipsSolid judgement with ability to make good decisionsStrong knowledge of project management tools/software, and digital solutionsStrong proficiency in English. Other languages are an added advantage.Strong presentation and communication skills.Being able to collaborate across functions Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Manager, Manufacturing Project Management Location:BaselContract: Temporary for 6 monthsIn this role, the Manager, Project Management will develop strong oversight and governance mechanisms for various work streams as the international organization is set up and scales up operations. These work streams include international CMO startup, Fill/Finish capacity ramp up, Logistics and Supply Chain setup and integration with Global processes, Quality Assurance and control setup, regulatory requirement compliance, people & organization ramp up, and setup of the Finance support infrastructure Your Responsibilities: Establish, manage and lead cross-functional project teamsRepresent this project and other project sponsors for accelerated scale up of international manufacturingCreate and maintain detailed project plans to ensure clarity of deliverables and timingTrack project tasks and efforts associated with organization and process setup of multiple functions e.g. Manufacturing, Tech Transfer, Supply Chain, Logistics, Quality, Regulatory, FinanceCoordinate scheduling and facilitating meetings, sending out agendas, writing and distributing minutes, managing team documentation, and tracking goals and action items Your profile:Education: University degree in an appropriate discipline (e.g. sciences, engineering, business)Experience: 8+ years in Pharmaceutical/Biotechnology DevelopmentThe successful candidate will have demonstrated experience in leading cross-functional development programs in both early (i.e. Phase 1/IND) and late stage (Phase 3/BLA)Ability to work in a fluid environment and foster a strong collaborative spiritAbility to negotiate and sustain networking relationshipsSolid judgement with ability to make good decisionsStrong knowledge of project management tools/software, and digital solutionsStrong proficiency in English. Other languages are an added advantage.Strong presentation and communication skills.Being able to collaborate across functions Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position 
    • lausanne, vaud
    • temporary
    Do you have several years of experience in quality in the medical industry ? Do you like to take part in multi team projects ? You should then read the following description!For one of our clients, we are looking for a Global Product Development Quality Lead, for their site in the Lausanne area. The mission is to last from 01.03.2022 until the end of Jan 2023. Tasks:Lead the Quality Management System (QMS) for Combination Products (CP) across different departments.Ensure quality of product development through Good Manufacturing Practices (GMP) or relevant requirements.Secure compliant product availability to patients and consumers for (pre-)clinical/claim studies.Reviewing/approving quality deliverables related to products in development within manufacturing facilities as well as CDMOsProviding quality expertise on GDP/GMP/ISO requirements during product early and late clinical phasesQuality representative in product development projectsProviding support for product transfers to commercial phaseEnsuring qualification of vendors used in development project Organizing/performing quality audits for products in developmentResponsible for QMS elements like IP complaints, deviations and CAPAsRegular meetings and collaboration with main stakeholders (CMC Project Managers, Regulatory, Clinical Supply Representatives, Clinical Project Managers and commercial QA)Quality Representative in MD division including following duties/responsibilities:responsible for Quality Control and Quality Assurance activities used to ensure processes are sufficient to detect and control nonconformities encountered during design and manufacturing maintaining Quality Manual, QMS policies, procedures, and work instructions for MDs and Combination Productssupervising operational quality activities (Change Controls, Nonconformities, Development Reviews….) for MD and Combination ProductsProfile:University degree in Science including Chemistry, Biology, Pharmacy, Engineering.Advanced courses on GMP/GDPExperience in the pharmaceutical/biotech/medical devices industrySolid background in QualityProject management skillsRegulatory inspection experience Those lines sound familiar and appealing to you ? Apply now!
    Do you have several years of experience in quality in the medical industry ? Do you like to take part in multi team projects ? You should then read the following description!For one of our clients, we are looking for a Global Product Development Quality Lead, for their site in the Lausanne area. The mission is to last from 01.03.2022 until the end of Jan 2023. Tasks:Lead the Quality Management System (QMS) for Combination Products (CP) across different departments.Ensure quality of product development through Good Manufacturing Practices (GMP) or relevant requirements.Secure compliant product availability to patients and consumers for (pre-)clinical/claim studies.Reviewing/approving quality deliverables related to products in development within manufacturing facilities as well as CDMOsProviding quality expertise on GDP/GMP/ISO requirements during product early and late clinical phasesQuality representative in product development projectsProviding support for product transfers to commercial phaseEnsuring qualification of vendors used in development project Organizing/performing quality audits for products in developmentResponsible for QMS elements like IP complaints, deviations and CAPAsRegular meetings and collaboration with main stakeholders (CMC Project Managers, Regulatory, Clinical Supply Representatives, Clinical Project Managers and commercial QA)Quality Representative in MD division including following duties/responsibilities:responsible for Quality Control and Quality Assurance activities used to ensure processes are sufficient to detect and control nonconformities encountered during design and manufacturing maintaining Quality Manual, QMS policies, procedures, and work instructions for MDs and Combination Productssupervising operational quality activities (Change Controls, Nonconformities, Development Reviews….) for MD and Combination ProductsProfile:University degree in Science including Chemistry, Biology, Pharmacy, Engineering.Advanced courses on GMP/GDPExperience in the pharmaceutical/biotech/medical devices industrySolid background in QualityProject management skillsRegulatory inspection experience Those lines sound familiar and appealing to you ? Apply now!
    • la chaux-de-fonds, neuchâtel
    • temporary
    Pour notre client international situé près de Neuchâtel et actif dans les équipements médicaux, nous recherchons un(e) Ingénieur(e) Packaging. Il s’agit d’une mission intérimaire de 12 mois (démarrage dès que possible). Vos tâches:Vous conduisez et participez à la qualification de nouveaux équipements et processusVous conduisez et participez aux activités de validation packaging et processus packaging (IQ OQ PQ)Vous conduisez et participez à des projets d’amélioration de processus ou de fluxVous assurez le support de production en cas de problèmes sur les lignesVous effectuez une analyse des problèmes, définition de solutions et d'actions et suivi de plans d'actionsVous traitez les NC-NR, CAPAVous prenez des décisions concernant des choix techniques sur les projets                          Vous prenez des décisions concernant les aspects Sécurité / Environnement                       Vous prenez des décisions concernant le déroulement de projet en tant que leaderVous formez des opérateurs sur les équipements et processus  Votre profil:Vous avez un Diplôme Universitaire/Bachelor ou titre jugé équivalent dans les domaines industriels suivants : Médical, Microtechnique, MécaniqueVous avez une expérience du monde médical et des validationsVous avez des connaissances de l’assurance qualitéVous avez des connaissances des normes Qualité / Sécurité / Environnement relatives à son domaine technique.Vous avez une bonne expérience dans la gestion de projet.Vous maitrisez l'anglais, parlé et écrit 
    Pour notre client international situé près de Neuchâtel et actif dans les équipements médicaux, nous recherchons un(e) Ingénieur(e) Packaging. Il s’agit d’une mission intérimaire de 12 mois (démarrage dès que possible). Vos tâches:Vous conduisez et participez à la qualification de nouveaux équipements et processusVous conduisez et participez aux activités de validation packaging et processus packaging (IQ OQ PQ)Vous conduisez et participez à des projets d’amélioration de processus ou de fluxVous assurez le support de production en cas de problèmes sur les lignesVous effectuez une analyse des problèmes, définition de solutions et d'actions et suivi de plans d'actionsVous traitez les NC-NR, CAPAVous prenez des décisions concernant des choix techniques sur les projets                          Vous prenez des décisions concernant les aspects Sécurité / Environnement                       Vous prenez des décisions concernant le déroulement de projet en tant que leaderVous formez des opérateurs sur les équipements et processus  Votre profil:Vous avez un Diplôme Universitaire/Bachelor ou titre jugé équivalent dans les domaines industriels suivants : Médical, Microtechnique, MécaniqueVous avez une expérience du monde médical et des validationsVous avez des connaissances de l’assurance qualitéVous avez des connaissances des normes Qualité / Sécurité / Environnement relatives à son domaine technique.Vous avez une bonne expérience dans la gestion de projet.Vous maitrisez l'anglais, parlé et écrit 
    • vaud, genève
    • temporary
    Do you have a strong experience with combination products ? Do you want to join a leading multinational company ? You should then read the following lines!We are looking for a DHF Manager for one of our client based in Vaud, for a 7 months contract. Your tasks:Responsible for establishing DHF structure templateResponsible to define and compile documents that needs to be included in the DHFEnsure identified documents to be part of the DHF are compliant and fit with Health Authority standard and submission needs (mostly for US and EU)Responsible for identifying the gap of the existing DHF with the compliance requirements (US and EU) and new defined DHF structure. Propose and action plan accordinglyCoordinate the remediation activities and Perform DHF documents remediation accordingly in collaboration with accountable/responsible functionsDefine mandatory sources documents and ensure their availability and appropriate quality for filing a dossier. This can be testing raw data, tests results, third party reports, qualification documents, etc.…DHF documents update, maintenance and clean-up as neededSupport on defining and combining needed output for design transfer Support the authoring of design transfer plans and/or reportsHighlight and report risks related to DHF quality or missing partsPrioritize documents update/creation and remediation activities according to project identified risks and potential impact on submissionsSupport Design Review documents completionSupport documents review (especially documents from third parties and external consultants)Responsible for DHF transfer from SharePoint to Icologiq (any new document management system)  Your profile:Bachelor’s degree (or equivalent) in an applicable Product design, Scientific/engineering backgroundDeep understanding of combination product / medical device, design control, documentation control, change control, quality system per ISO 13485, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development planStrong interpersonal and relationship building skills with the ability to establish a trusted role with the various stakeholdersSolid organizational skills including attention to detail and multi-tasking skillsProblem solver mindset; good sense of autonomy and prioritizationEffective verbal and written communicationFluent in English, both oral and written; additional languages (German or French) are an assetProject management experience is a plus. Quality engineering experience; Design Control, Experience in medical devices, EU and US submissionThose lines sound interesting to you ? Apply now and do not waste a second!
    Do you have a strong experience with combination products ? Do you want to join a leading multinational company ? You should then read the following lines!We are looking for a DHF Manager for one of our client based in Vaud, for a 7 months contract. Your tasks:Responsible for establishing DHF structure templateResponsible to define and compile documents that needs to be included in the DHFEnsure identified documents to be part of the DHF are compliant and fit with Health Authority standard and submission needs (mostly for US and EU)Responsible for identifying the gap of the existing DHF with the compliance requirements (US and EU) and new defined DHF structure. Propose and action plan accordinglyCoordinate the remediation activities and Perform DHF documents remediation accordingly in collaboration with accountable/responsible functionsDefine mandatory sources documents and ensure their availability and appropriate quality for filing a dossier. This can be testing raw data, tests results, third party reports, qualification documents, etc.…DHF documents update, maintenance and clean-up as neededSupport on defining and combining needed output for design transfer Support the authoring of design transfer plans and/or reportsHighlight and report risks related to DHF quality or missing partsPrioritize documents update/creation and remediation activities according to project identified risks and potential impact on submissionsSupport Design Review documents completionSupport documents review (especially documents from third parties and external consultants)Responsible for DHF transfer from SharePoint to Icologiq (any new document management system)  Your profile:Bachelor’s degree (or equivalent) in an applicable Product design, Scientific/engineering backgroundDeep understanding of combination product / medical device, design control, documentation control, change control, quality system per ISO 13485, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development planStrong interpersonal and relationship building skills with the ability to establish a trusted role with the various stakeholdersSolid organizational skills including attention to detail and multi-tasking skillsProblem solver mindset; good sense of autonomy and prioritizationEffective verbal and written communicationFluent in English, both oral and written; additional languages (German or French) are an assetProject management experience is a plus. Quality engineering experience; Design Control, Experience in medical devices, EU and US submissionThose lines sound interesting to you ? Apply now and do not waste a second!
    • basel, basel-stadt
    • temporary
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Senior Associate, International Manufacturing Operations Location:BaselContract: Temporary for one year. This role is an exciting opportunity to be part of a growing Supply Chain/Manufacturing group. Reporting to Director of International Manufacturing, the successful candidate will work closely with the CMO manufacturing function and Supply Chain function to ensure that the SAP operations are accurate, on track, and in line with GMP compliance and regulatory requirements.Your Responsibilities: Weekly open order book management in collaboration with Manufacturing/Supply Chain in the CMO. The objective is to ensure that the CMO is on track to deliver all released process orders, on-time and in-full. Risks, Opportunities and Issues should be raised and resolved daily.  Daily, or Weekly, Toll material reconciliation process to ensure: All usage of company-owned toll manufacturing materials, by the CMO, is reconciled and accounted for, and that investigations are performed when reconciliation results are outside pre-defined thresholds. That material usage, and inventory transactions, at the CMO are accurately reflected in the SAP system, in a timely way. This can be achieved either through company/CMO system interfaces, or through a manual toll-reconciliation process owned by the Planner.  Execute good receipt and inventory movement transactions required to ensure cross system inventory placement / inventory accuracy Execute the regular raw materials booking within the open process orders in line with CMOs information.Executed Process Orders TECO once that the process orders operations are completed  Ensure compliance with GMP and regulatory requirements (including records management) and spearheads continuous improvements for quality financial flow processes. Your profile:Bachelor level degree in Supply Chain, Business or related field  Between 2 and 3 years of experience in the manufacturing Site preferably as Batch Record Reviewer  Experience in Operation of a highly regulated industry, like Pharmaceutical or related field.  Experience executing SAP Process Orders Raw Materials consumption/Booking .  Ability to manage multiple topics in a fast-paced environment and deal with different stakeholders from different domains in the organization.  Demonstrated ability to critically think and identify solutions.  Well organized – a natural ability to be organized in how you think, communicate and conduct your work  A curious mindset that allows you to constantly learn and challenge the status quo You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position
    Do you wish to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative ?For our client, this pioneering biotechnology company, we are looking for a: Senior Associate, International Manufacturing Operations Location:BaselContract: Temporary for one year. This role is an exciting opportunity to be part of a growing Supply Chain/Manufacturing group. Reporting to Director of International Manufacturing, the successful candidate will work closely with the CMO manufacturing function and Supply Chain function to ensure that the SAP operations are accurate, on track, and in line with GMP compliance and regulatory requirements.Your Responsibilities: Weekly open order book management in collaboration with Manufacturing/Supply Chain in the CMO. The objective is to ensure that the CMO is on track to deliver all released process orders, on-time and in-full. Risks, Opportunities and Issues should be raised and resolved daily.  Daily, or Weekly, Toll material reconciliation process to ensure: All usage of company-owned toll manufacturing materials, by the CMO, is reconciled and accounted for, and that investigations are performed when reconciliation results are outside pre-defined thresholds. That material usage, and inventory transactions, at the CMO are accurately reflected in the SAP system, in a timely way. This can be achieved either through company/CMO system interfaces, or through a manual toll-reconciliation process owned by the Planner.  Execute good receipt and inventory movement transactions required to ensure cross system inventory placement / inventory accuracy Execute the regular raw materials booking within the open process orders in line with CMOs information.Executed Process Orders TECO once that the process orders operations are completed  Ensure compliance with GMP and regulatory requirements (including records management) and spearheads continuous improvements for quality financial flow processes. Your profile:Bachelor level degree in Supply Chain, Business or related field  Between 2 and 3 years of experience in the manufacturing Site preferably as Batch Record Reviewer  Experience in Operation of a highly regulated industry, like Pharmaceutical or related field.  Experience executing SAP Process Orders Raw Materials consumption/Booking .  Ability to manage multiple topics in a fast-paced environment and deal with different stakeholders from different domains in the organization.  Demonstrated ability to critically think and identify solutions.  Well organized – a natural ability to be organized in how you think, communicate and conduct your work  A curious mindset that allows you to constantly learn and challenge the status quo You would like to contribute to a fast-thinking and innovative company, changing the industry ? Apply nowPlease note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position

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