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AC Immune SA

Favori

22/07/2024

AC Immune SA

Drug Product Process Development Engineer

  • AC Immune SA

  • Lausanne

  • 22/07/2024

  • Emploi permanent 100%

Emploi permanent 100%

Lausanne

Drug Product Process Development Engineer Description Function Drug Product Process Development Engineer Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne hr@acimmune.com Percentage 100 % Reporting Line DP Manufacturing Science and Technology Group Leader Overview AC Immune is a clinical-stage Swiss Biotech Company focused on the development of innovative therapeutics and diagnostics for Alzheimer’s and other neurodegenerative diseases. Job description The Drug Product Process Development Engineer will assist the technology transfer, process optimization and scale-up for all drug product manufacturing development activities to contract manufacturing organizations. The candidate will also assist build- up of in-house vaccine manufacturing capabilities to facilitate industrialization of newly developed processes. Key responsibilities Assist technology transfer and scale-up of all manufacturing activities until GMP production. Carry out risk analyses and PFMEA on manufacturing processes Liaise internally within AC Immune and externally with CMOs to fill identified gaps and/or mitigate risks to ensure successful technology transfers Plan and monitor the engineering runs. Carry out process performance analysis Assist initiation of GMP manufacturing activities Ensure mirroring of manufacturing processes between AC Immune and CMOs Identify pilot-scale equipment suitable for in-house manufacturing activities, contact external vendors, carry out RFI/RFP process to assess equipment/system suitability to build these capabilities Contribute to maintenance of inventory of materials and consumables used by the MFG team Support budget preparation related to in-house operations Qualifications Qualifications: Bachelor or MSc in process engineering, pharmaceutical engineering, systems engineering, mechanical engineering or similar Has at least 5 years of industrial experience, with expertise in multiple types of industrial equipment and processes (mixers, filtration, purification devices). Has proven expertise in failure mode analysis and process performance analysis. Has demonstrated ability to solve complex engineering challenges in highly dynamic environments with internal and external stakeholders Has demonstrated ability to analyze data and generate reports Personal features include: Strong technical acumen Ability to integrate and learn fast Strong interpersonal skills for efficient collaboration with all colleagues Fluency in spoken and written English
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Favori

22/07/2024

AC Immune SA

Quality Control Lead

  • AC Immune SA

  • Lausanne

  • 22/07/2024

  • Emploi permanent 100%

Emploi permanent 100%

Lausanne

Quality Control Lead – NEW Description Function Quality Control Lead Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne careers@acimmune.com Percentage 100 % Reporting Line Analytical Development & Quality Control (ADQC) Group Leader Overview AC Immune is a clinical-stage Swiss Biotech Company focused on the development of innovative therapeutics and diagnostics for Alzheimer’s and other neurodegenerative diseases. AC Immune is seeking a highly qualified Quality Control Lead to support its CMC product development programs. The candidate must possess a strong background in Analytical Chemistry or equivalent and must have extensive Quality Control experience, preferably in the (bio)pharmaceutical industry and in the interface with Quality Assurance and Regulatory Affairs functions. Job description •Lead and manage analytical method transfer, qualification and/or validation activities to/at external partner(s) or Contract Research Organizations (CROs), including revision and approval of required documentation, for Drug Products, APIs and raw materials Ensure that Release, Characterization and Stability testing by partners or Contract manufacturing Organizations (CMOs) and CROs is performed in compliance with cGMP/GLP/ICH/USFDA/ISO guidelines and aligned with internal and industry quality standards. Manage and/or support the OOS/OOT/OOE and any other analytical related Deviations, CAPAs, Change Control, etc in close collaboration with QA /RA department and ADQC team. Prepare, review and evaluate internal and third party SOPs, WIs, procedures and guidelines Ensure high quality analytical documentation for submission to Health Authorities Train regularly the ADQC team on quality control measures and requirements regarding analytical testing procedures, equipment qualification, data recording, laboratory management, etc Qualifications •Ph.D. or equivalent in Analytical Chemistry, Biochemistry or related discipline applied to the analysis of large molecules Quality Control or analytical QC-related expertise (≥ 10 years) in the pharmaceutical/biotech field preferably interacting within multi-disciplinary teams Deep working knowledge of method development and validation of analytical methods for New Biological Entities Successful record of interaction with Regulatory Affairs and expertise in applicable regulations in the field of analytics (i.e. Ph.Eur./USP monographs and chapters, and cGMP/GLP/ICH/USFDA/ISO guidelines) Personal features include: Team spirited with strong organizational, problem-solving and analytical skills Autonomous with good judgment and ability to make decisions in a timely manner Demonstrated ability to manage multiple tasks at once Strong interpersonal skills to build efficient relationships and communication within the team and at the interface with other departments Proven Leadership ability and project management skills Good spoken and written English are required Would be a plus: Expertise in the Quality Control of New Chemical Entities Experience in Quality Assurance
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Favori

15/07/2024

AC Immune SA

Director Quality Assurance

  • AC Immune SA

  • Lausanne

  • 15/07/2024

  • Emploi permanent 100%

Emploi permanent 100%

Lausanne

Description Function Director Quality Assurance AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne Location / Contact E-Mail schreiben Percentage 100% Reporting Line The Director QA reports directly to the Senior VP Regulatory Affairs & QA Company Profile - AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases. - 160+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ - AC Immune SA is a progressive, equal opportunity employer Job description AC Immune is seeking a Director QA responsible for providing strategic direction and leadership for the global QA function and drive for continuous improvement through embedding a quality culture across the company. A proven expert in the field, the Director QA will lead the continued development of the QA function in support of the company's activities and be responsible for the quality and compliance activities for its chemical and biological products which are in clinical phases. Key responsibilities Lead the QA team Develop the annual quality plan. Monitor progress via Quality Councils. Lead the continuous development and maintenance of the QMS in collaboration with other Functions, including the development and review of procedures Support concerned departments with the implementation of processes to ensure full GxP compliance (internal audit) Review and approve quality related documentation (protocols, reports, technical agreements, specifications, change controls, deviations and CAPAs, CSV documentation ) Oversee the vendor qualification and monitoring activities (external audits) Represent QA on Project teams by providing GxP QA expertise to Clinical, Technical Operations and Research Lead and manage inspection readiness, including hosting inspections Monitor the evolving regulatory/quality landscape Oversee archiving activities at the company level Required: Qualifications & skills The candidate must have the following qualifications: Graduate degree in pharmacy, chemistry or equivalent education in a technical/scientific subject. At least 15 years of proven experience in QA in the Pharmaceutical Industry GxP environment for chemicals and/or biologicals: - Expertise of GMP, GCP and GLP standards July 2024 Experience in the Research and Development environment, including laboratory, analytical or manufacturing technical background Good understanding of drug substance / drug product development, manufacturing process, quality control, packaging and distribution of Investigational Medicinal Products Strong experience in GMP manufacturing and quality control of New Biological Entities Knowledge of (Bio)-analytical method qualification and validation Conduct of internal / external audits - Personal features include: Demonstrated ability to synthesize, analyze and communicate key information Strong interpersonal skills for building networks with key experts and ensuring the interface with internal departments Ability to adapt priorities to meet company needs while maintaining effectiveness Leadership and project management skills Good spoken and written English are required Would be a big plus: Knowledge/expertise of Computer System Validation Experience in the manufacture and testing of radiolabeled product for human use July 2024
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Favori

15/07/2024

AC Immune SA

Quality Assurance Archiving Administrative Assistant

  • AC Immune SA

  • Lausanne

  • 15/07/2024

  • Emploi permanent 100%

Emploi permanent 100%

Lausanne

Description Function QA Archiving Administrative Assistant Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage 40 % Reporting Line Corporate Company Archivist Company Profile AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA is a progressive, equal opportunity employer AC Immune is seeking a Quality Assurance Archiving Administrative Job description Assistant to assist the Corporate Company Archivist with the coordination and processing of archives. The archiving assistant will be responsible for ensuring compliance of the archiving activities with the internal processes. Key Responsibilities Liaise and coordinate with department and project archivists Perform archiving activities including indexing, formatting, editing, scanning, protecting, and tracking documentation Perform Quality Check on documents to be archived (e.g. verifying that nomenclatures are applied) Support dispatch with external archiving facilities Qualifications & Skills Required: Administrative background Fluent in English and/or French (or at least C1 level in English) Good organizational and communication skills Demonstrate attention to detail and multi-tasking abilities Good command of Microsoft suite Ability to adapt priorities to meet company needs while maintaining effectiveness Experience in working for an international organization
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Favori

14/07/2024

AC Immune SA

QA Archiving Administrative Assistant 40%

  • AC Immune SA

  • Lausanne

  • 14/07/2024

  • Emploi permanent 40%

Emploi permanent 40%

Lausanne

Description Function QA Archiving Administrative Assistant Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne careers@acimmune.com Percentage 40 % Reporting Line Corporate Company Archivist Company Profile •AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer’s and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA is a progressive, equal opportunity employer Job description AC Immune is seeking a Quality Assurance Archiving Administrative Assistant to assist the Corporate Company Archivist with the coordination and processing of archives. The archiving assistant will be responsible for ensuring compliance of the archiving activities with the internal processes. Key Responsibilities •Liaise and coordinate with department and project archivists Perform archiving activities including indexing, formatting, editing, scanning, protecting, and tracking documentation Perform Quality Check on documents to be archived (e.g. verifying that nomenclatures are applied) Support dispatch with external archiving facilities Qualifications & Skills Required: Administrative background Fluent in English and/or French (or at least C1 level in English) Good organizational and communication skills Demonstrate attention to detail and multi-tasking abilities Good command of Microsoft suite Ability to adapt priorities to meet company needs while maintaining effectiveness Experience in working for an international organization
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Favori

09/07/2024

AC Immune SA

Clinical Lead

  • AC Immune SA

  • Lausanne

  • 09/07/2024

  • Emploi permanent 100%

Emploi permanent 100%

Lausanne

Clinical Lead Description Function Clinical Lead Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne hr@acimmune.com Percentage 100 % Reporting Line Head of Clinical Development Company Profile •AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer’s and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA (ACIU) is a progressive, equal opportunity employer Job description Clinical Lead takes responsibility to lead the clinical development activities of one or more clinical programs. Current clinical programs focus on neurodegenerative diseases (eg., Alzheimer’s disease, Parkinson disease). She/He develops the clinical development plans and clinical project strategy, including a translational biomarker strategy. The Clinical Lead participates notably to the clinical study team and core team, representing the clinical development. As a key contributor she/he takes responsibility for developing study plans and protocols according to the agreed company’s strategy. The Clinical Lead is responsible to implement the clinical and biomarker development strategy notably based on data from the competitive landscape and from the most recent state of the art, medical and scientific knowledge. She/He takes part in and supervises all the key steps related to the preparation, the conduct and the completion of the clinical studies, including the medical and safety monitoring, associated to the related clinical program sponsored by ACIU. She/He also provides appropriate support to the clinical operations team and other key stakeholders. Key Responsibilities •Leads the direction, planning, execution and interpretation of assigned clinical trials, with a focus in neurodegenerative diseases. Takes part in the elaboration of clinical strategy and clinical communication, with a leading role in neurodegenerative diseases. Leads the development of the assigned clinical development program and 5-year clinical plans in alignment with ACIU strategy. Ensures/supervises the interpretation of the data from internal clinical trials and from competitors. Establishes/reviews clinical study designs and implement clinical protocols, data collection systems and final clinical study reports. Supervises, in respect with GCP, adherence to protocols and to clinical reports including medical/safety aspects. Supervises/takes part in the medical and safety monitoring and reports promptly serious adverse events or any safety concerns considered of medical significance according to internal SOPs. Takes part in the DSMB blinded meetings. Prepare/takes part in investigator’s meetings. Generates presentations, publications and interfaces with KOLs, external experts, advisory boards, and health authorities. Provides medical support to due diligences associated with in-licensing, acquisitions, and co-development agreements, under supervision of the head of clinical development and the CMO. Clinical Lead Ensures/handles clinical interfaces with external partners. Ensures competitive intelligence in the related field in order to implement a state-of-the-art approach for the related clinical development program and clinical studies. Supervises/provides support on the preparation, the review and the finalization of key clinical documents including, but not limited to, clinical development plan, clinical protocols and related amendments, clinical study reports, investigator’s brochures, DSURs, and other key study documents as appropriate. Provides support to the clinical operation team and other stakeholders as needed. Qualifications & Skills Required: MD or MD/PhD Expertise or training in Neurosciences. Experience in clinical development programs in Central Nervous System Diseases, Neurodegenerative Diseases. 5+ years of experience in clinical development (academic and/or pharmaceutical or biotech companies) including preparation of key clinical study documents (e.g., but not limited to clinical study protocols, investigator’s brochures). Knowledge of clinical development process and related guidelines, GCP, ICH. Experienced in the establishment and the maintenance of communication with KOLs, external experts and regulatory authorities. Advanced communication skills, verbal and written. Team player. Demonstrated ability to synthesize, analyze and communicate key information. Strong interpersonal skills for building networks with key experts and ensuring the interface with internal departments and project team members. Ability to adapt priorities to meet company needs while maintaining effectiveness. Leadership and project management skills. Good spoken and written English. Would be a big plus: Neurologist Experience in pharmacovigilance. Experience in translational sciences.
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Favori

30/06/2024

AC Immune SA

Clinical Project Manager

  • AC Immune SA

  • Lausanne

  • 30/06/2024

  • Emploi permanent 100%Gestion/Cadre

Emploi permanent 100%

Gestion/Cadre

Lausanne

Description Function Clinical Project Manager (CPM) Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne hr@acimmune.com Percentage 100 % Reporting Line Head of Clinical Operations (HCO) Company Profile •AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer’s and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA is a progressive, equal opportunity employer Job description The Clinical Project Manager will be responsible, under the supervision of the HCO, of the management of regional and/or international studies, alone or in collaboration with a Lead CPM, according to time, cost and quality standards. Key Responsibilities •Manage international clinical studies according to time, cost and quality standards Negotiate, implement and maintain contracts with study partners (study vendors, sites) Manage activities of study partners, support clinical CRO in managing the sites Review and approve submission packages for submission to Ethics Committees/Institutional Review Boards Supply proper documentation to the Regulatory department for submission to Regulatory Authorities Contribute to the generation of SOPs/WIs Participate in clinical study design Create and maintain operational plans Prepare study budgeting and forecasting Global budget management of studies Ensure the accurate planning and ordering of clinical study drug supply Lead study protocol development Write and update clinical study documents Participate to review and approval of the Clinical Trial Report Be responsible for the Trial Master File Participate in study specific core team meetings Qualifications & Skills Required: A scientific degree is required as well as the ability to work in a start-up environment, handling multiple demands and strong planning and organizational skills Minimum of 4 years of experience in clinical research (preferably with 2 years coordinating international or leading regional studies) Knowledge in international standards (GCP/ICH) as well as in international (FDA/EMA) and local regulations Hands on experience in writing clinical study documents Good spoken and written English Personal features include: Advanced understanding of timelines, budget and resource management Planning, tracking and solving skills for maintaining project timelines Networking skills Working both independently and in a cross-functional team setting
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