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Biologie: 6 Jobs in Dachau

Berufsfeld
  • Biologie
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  • Pharmaindustrie 3
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Biologie

Organisatorische Leitung (w/m/d) Biobank

Mi. 12.05.2021
München
Ihr Universitätsklinikum im Herzen Münchens Wir sind das Klinikum rechts der Isar (MRI) der Technischen Universität München (TUM) und verläss­licher Arbeitgeber für rund 6.000 Mit­arbeiter*innen. Als Uni­klinikum widmen wir uns neben der Kranken­versorgung auch der Forschung und Lehre – entsprechend unserem Leit­bild „Wissen schafft Heilung“ – und genießen national wie inter­national einen aus­gezeichneten Ruf. Die Klinik und Poliklinik für Neurologie sucht zum nächst­möglichen Zeitpunkt in Vollzeit eine Organisatorische Leitung (w/m/d) Biobank Wir am Klinikum rechts der Isar arbeiten unermüd­lich daran, die Therapie von chronischen Erkran­kungen wie Krebs, Rheuma oder auch degenerativen oder auto­immunen neurologischen Erkran­kungen zu verbessern. Ein erster Schritt ist, die Ursachen und Ver­läufe dieser Erkran­kungen besser zu verstehen. Dafür analysieren wir große Mengen an klinischen Informationen, bild­gebenden Untersuchungen und Bio­materialien, die in verschiedenen Daten- und Biob­anken vorgehalten werden. Wir sehen darin die Grund­lage für jeden Fort­schritt in der Medizin. „Big Data“ ist die Zukunft.Organisation und Leitung des opera­tiven Geschäfts der bestehenden Bio­bank der Klinik für Neurologie, dazu gehören: Koordination der Sammlung, Auf­bereitung, Dokumentation, Lagerung und Distribution von Bio­proben sowohl für lokale als auch über­regionale und internationale Forschungs­projekte Schnittstellenmanagement mit klinischen Routine­prozessen Kommunikation mit Studien­personal, Ärzten, IT-Personal, Forschern und Firmen Beratung von Wissenschaftlern zur Biomaterial­logistik (z.B. Präanalytik, Mengen­planung, Angebotserstellung) Organisation des Qualitäts­managements und Berichtswesens Strategieentwicklung zum nach­haltigen Betrieb der Biobank innerhalb der Leitungs­struktur „Datenmanagement“ der Klinik für Neurologie Abgeschlossenes Hochschul­studium der Biowissenschaften, Medizin oder eine vergleich­bare Qualifikation Wissenschaftliche Vorerfahrung im Bereich der Bio­wissenschaften, idealerweise im Bereich Biobanken Sie beherrschen die gängigen Labor­methoden der Biowissenschaften, einschließlich der Ver­fahren zur Datenauswertung  Kenntnisse im Qualitäts­management  Verhandlungssicheres Englisch in Wort und Schrift Teamgeist und über­durchschnittliches Engagement Verantwortungsvolle, selbst­ständige und gewissen­hafte Arbeitsweise Eine mit hoher Verantwortung verbundene Tätig­keit und ein vielseitiges Aufgabenspektrum Ein aufgeschlossenes und motiviertes Team Eine gute Work-Life-Balance im Rahmen einer 38,5-Stunden-Woche ohne Wechselschichten Einen Arbeitsplatz mitten in München mit sehr guter Erreichbar­keit durch öffentliche Verkehrs­mittel sowie Vergünstigung durch Jobtickets Vereinbarkeit von Familie und Beruf durch unseren Betriebskindergarten / ‑krippe, ergänzende Kinder­betreuung im Familienzimmer und Kinderferienbetreuung Leistungsgerechte Vergütung nach TV-L zuzüglich der attrak­tiven Leistungen des öffent­lichen Dienstes Schwerbehinderte Bewerber werden bei ansonsten im Wesent­lichen gleicher Eignung bevorzugt berück­sichtigt. Vorstellungs­kosten können leider nicht erstattet werden. Aus Gründen der Lesbar­keit wurde im Text die männ­liche Form gewählt, dessen ungeachtet beziehen sich die Angaben auf Angehörige aller Gender.
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Principal Biostatistician (gn)

Mi. 12.05.2021
Planegg
MorphoSys’ mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich! We would like to fill the following vacancy as soon as possible: Principal Biostatistician (gn) Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with leading edge knowledge and the overall product strategy Lead the development of the statistical analysis plan for clinical trials and historical control comparisons Provide specifications and directions to the statistical programmers in establishing standards for clinical conduct and data collection, management and/or reporting of data Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results for CSRs / ISE / ISS Provide guidelines and standards to CROs to ensure quality of deliverables Represent Biostatistics in meetings with cross-functional project teams ensuring adherence to FDA / ICH guidelines, Good Clinical Practices and regulatory requirements Contribute to interactions with external review boards / ethics committees, external consultants and key opinion leaders Contribute in process development including writing SOPs and mentor junior members of the team Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings Masters or PhD in the field of Medical Biometry with ideally five or more years industry experience Comprehensive knowledge and prior experience of advanced statistical methodology in clinical trials that apply to Phase I-IV clinical trials, adaptive study design, Bayesian analysis and regulatory requirements relating to clinical development of drugs Ability to initiate, drive and implement novel methods and innovative trial designs, including the development and review of study related documents (e.g. Statistical Analysis Plan, Statistical part of Study Protocols, Case Report Form, Data Management Plan, IDMC Charter) Profound knowledge of statistical software “Base SAS”, “SAS Macros”, “Addplan” and “R” Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards / imple­men­tation guides, 21 CFR Part 11, and FDA guidelines Expertise in medical research, especially oncology and inflammatory diseases Experience in calculating probability of study success, modelling and simulation Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure and in a team environment to meet established deadlines Experience in working in matrix organizations Teamplayer with well-developed interpersonal abilities Excellent written and oral communication skills in English, including grammatical / technical writing skills Creative working in X-functional teams Opportunities to work in Phase 3 studies and potential submissions Open and appreciative corporate culture Multicultural environment Working in an attractive, high-quality equipped building with restaurant Free sports and language courses
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(Senior) Global Product Manager Diagnostics (m/f/d) // Life Science / DNA / RNA Extraction / Lab Automation / MDx // Remote / Home Office possible

Di. 11.05.2021
Berlin, Hamburg, München, Köln, Düsseldorf, Frankfurt (Oder), Stuttgart, Bremen, Hannover, Nürnberg
International, fast-growing company • flat hierarchies • “start-up” spirit Remote / Home Office possible – 30% travelling Our client: We are a fast-growing biotechnology company in the field of molecular diagnostics of pathogens in animals. Our customers – veterinarians, industry and authorities – value us for our first-class and innovative products as well as our high reliability. We are active worldwide and improve diagnostic possibilities with cutting-edge technology.In this position you are responsible for the entire product development process including business case and feasibility studies, R&D, transfer to production, testing, compliance and launch. You develop sales strategies, pricing schemes and competitor analyses and are responsible for the corresponding product positioning and market communication to support Sales & Marketing. Moreover, you are in constant exchange with Regulatory Affairs and support the production planning team with forecast data and market trend information. Finally, product presentations, the product training of the sales team and the distributors and visiting customers, seminars, conferences and trade-shows to understand customer needs and learn about the latest developments, new ideas and technologies are part of your tasks. In this prominent position with responsibility for an outstanding product, you report directly to the executive management.Opportunity for Product Managers with entrepreneurial spirit and international mindset Do you have a qualified scientific degree (master's or doctorate), e.g. as an engineer or in (molecular) biology, biochemistry, biotechnology?Have you already launched products in the field of life science, diagnostics or laboratory automation? Also in an international context? Additional technology know-how needs to be developed; are you interested in digital PCR and Next Generation Sequencing (NGS)? Do you have the confidence to be responsible for the P&L as "CEO for your portfolio" and to manage the entire product development process from the idea to the business case and to design, testing, production, approval and finally launch? Do you also have the persuasive power of an excellent communicator, in English and as a plus also in German? And does your private situation allow you to travel regularly (approx. 30% / post-Covid)? Then you should not miss this opportunity!
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Project Manager Biopharma Excellence Consulting (f/m/d)

Mi. 05.05.2021
München
Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity! PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world. The success of our company grows with the excellent expertise and the high motivation of our employees. If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us. To strengthen our successful Biopharma Excellence team in Munich, we are looking as of now and limited to two years for a: Project Manager Biopharma Excellence Consulting (f/m/d) Classical project management of Biopharma Excellence projects Planning, controlling and documenting projects in close alignment with Program Managers Taking over project management tasks in all project stages and areas of activity Implementing operational and strategic planning Creating and maintaining of project plans Communicating with customers and authorities Supporting quality management and training activities Capacity planning, scheduling and cost planning of projects Supporting project infrastructure at the forefront of medical innovation Supporting of International Service Coordinator Biopharma Excellence Group You have preferably successfully completed a degree in life science in a scientific or related field You have professional experience in project management You bring excellent knowledge in the relevant processes and tools of project management Experience in the field of regulatory affairs is an advantage You have a solid understanding of business administration You command a high level of social competence, communication and organizational skills You are a team player, reliable and you have a structured working style You can communicate very well in English and German You are confident with MS Excel and MS Word You adapt quickly to new tools and CRM software - experience with CRM / ERP (moco) would be highly advantageous Experience with review of client CDA/NDA or Master Service Agreements would be highly advantageous Diverse and challenging job Working in a team of internationally recognized experts Quickly taking over responsibility and making a difference Open and appreciative corporate culture Flexible working hours based on trust Possibility to work reduced number of hours Possibility to work from home Continuous development opportunities through knowledge and experience as well as training
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Biologe / Landschaftsökologe (m/w/d) Schwerpunkt Kartierung

Mi. 05.05.2021
München
AFRY ist ein führendes europäisches Unternehmen für Ingenieur-, Design- und Beratungsdienstleistungen mit globaler Präsenz. Den Wandel zu einer nachhaltigeren Gesellschaft bringen wir als Unternehmen voran. Wir sind 17.000 engagierte Experten auf dem Gebiet der Digitalisierung und in den Bereichen Infrastruktur, Industrie und Energie, die nachhaltige Lösungen für kommende Generationen schaffen.  Die AFRY Deutschland GmbH ist flächendeckend an 16 Standorten mit insgesamt mehr als 500 Mitarbeitenden präsent. Wir unterstützen unsere Kunden in den Bereichen Verkehr, Wasser, Umwelt, Industrie, Energie und Digital Services. Zur Verstärkung unseres Teams am Standort München suchen wir aktuell einen Biologen / Landschaftsökologen (m/w/d) Schwerpunkt Kartierung Job Nummer: #148276 Durchführung und Auswertung faunistischer Erfassungen (Schwerpunkt Vögel, ergänzend Säugetiere, Reptilien und Amphibien) Eigenverantwortliche Planung und Steuerung von Projekten Projektbearbeitung in einem oder mehreren der folgenden Bereiche: Artenschutzfachbeiträge (saP), FFH-Verträglichkeitsprüfungen, Landschaftspflegerische Begleitpläne (LBP), Umweltscreenings oder UVP-Bericht Umweltbaubegleitung Abstimmung mit Auftraggebern, Sachverständigen und Behörden Abgeschlossenes Studium im Bereich Umweltplanung / Ingenieurökologie, Biologie, Landespflege / Landschaftsarchitektur oder einer vergleichbaren Studienrichtung Umfassende Kenntnisse zu den planungsrelevanten Artengruppen und den Erfassungsmethoden Mehrjährige Erfahrung in der faunistischen Kartierarbeit erforderlich, insbesondere zur Artengruppe der Avifauna Gute Kenntnisse des Natur-, Umwelt-, Artenschutzes, des Planungsrechts sowie der FFH-Richtlinie Gute MS Office Kenntnisse, ArcGIS-Anwenderkenntnisse sind von Vorteil Organisationstalent, Flexibilität und Qualitätsbewusstsein Sicheres Auftreten im Umgang mit Auftraggebern und den zu beteiligenden Teamplayer, hohes Maß an Engagement und Belastbarkeit Eine spannende Position mit großer Einflussmöglichkeit in einer starken Wachstumsorganisation, die sich auf Nachhaltigkeit und zukunftsweisende Technologie konzentriert Es erwarten Sie nette, engagierte und talentierte Kollegen in einem integrativen Arbeitsumfeld. Wir fordern und unterstützen uns gegenseitig, um das Beste aus uns herauszuholen. Die Möglichkeit sich stetig in einem interdisziplinären Aufgabenumfeld weiterzuentwickeln mit vielfältigen Karrierechancen Attraktive Konditionen, betriebliche Altersvorsorge, Unfallversicherung, Entgeltsicherung im Krankheitsfall sowie Flexibilität bei der Vereinbarkeit von Beruf und Privatleben u.v.m. Angebote zur individuellen Gesundheitsförderung, u. a. Gesundheits- und Sportaktivitäten, JobRad sowie Sozialberatung und Vermittlungsservice für verschiedene Beratungsthemen​ Wir bei AFRY legen Wert auf Vielfalt. Wir respektieren und schätzen die Unterschiede der Menschen. Wir unterstützen die Chancengleichheit aller unserer Mitarbeiter und Bewerber. Klingt die Position spannend für Sie? Dann bewerben Sie sich noch heute auf die Stelle unter Angabe der Job Nummer: #148276 mit Ihren Gehaltsvorstellungen und Angaben zur Verfügbarkeit! Wir freuen uns von Ihnen zu hören!
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Senior Manager GCP Audit (m/f/x)

Fr. 30.04.2021
München
Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For our headquarter in Munich we are seeking highly qualified candidates to fill the position: Senior Manager GCP Audit (m/f/x) The Senior Manager GCP Audit will provide assurance to the Global QA GxP Audits Team that the QA GCP audits and due diligence efforts are fully functional and compliant with ICH GCP, the applicable national and international laws and guidelines and global Daiichi Sankyo written procedures. This role is responsible for the assurance to the Global Daiichi Sankyo Quality Management that all aspects of GCP regulatory inspections, vendor and clinical site by Competent Authorities / Health Authorities will be handled and managed adequately and appropriately. Roles and responsibilities: Manage assigned aspects of a fully functional QA GCP audit program as assigned by the Head Global GxP audits for Daiichi Sankyo Global phase I through IV studies of clinical development and supporting discovery phase QA activities where necessary Manage and execute the investigator site, service provider and internal systems and process audit program to assure an all acceptable state of compliance Support all aspects of GCP regulatory inspections at investigator sites, CROs, vendors and sponsor facility during preparation, conduct, coordinating responses to inspections, and to ensure supporting documentation, tracking and verification of CAPA implementation Assure that all studies managed by DSE or are performed under DSE legal responsibility are in compliance with GCP requirements and can withstand scrutiny from regulators in all countries where Daiichi Sankyo conducts clinical trials  Manage metrics and the implementation tracking of corrective and preventive actions as follow-up to audits and inspections Work with Daiichi Sankyo Japan, Daiichi Sankyo USA and other Daiichi Sankyo QA groups in developing and implementing QA GCP objectives and audit schedules with regards to development related audits of CROs, investigator sites, bioanalytical labs, etc. Collaborate and represent the Global QA group in conducting joint audits and global SOP development. Liaise and consult with Early and Late Strategy, Development Teams, Pharmacovigilance, Operational and Technical Services and others to ensure local and global compliance with regulatory requirements, good clinical practice, internal standards, and to provide pro-active integration of quality and process improvement Bachelor´s degree required - life sciences degree preferred, e.g. Biology Demonstrated expertise and specific technical knowledge of the GCP (and PV) areas subject to audit, as evidenced by at least in the pharmaceutical industry and / or biotech industry  Minimum 5 years of GCP auditing experience; additional PV auditing experience preferred  Experience in preparing, hosting and following-up of regulatory authority inspections Profound knowledge of international GCP regulations and guidelines Excellent understanding of the drug development process and end to end quality process Excellent oral and written communication skills in English, German and ideally one other European Language User knowledge in MS Office 365, Trackwise, Veeva or similar software Team player who can work interculturally and is willing to travel 30% across Europe and globally We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.
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