The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place. Areas of key responsibility include Drug Product (DP) technical support and oversight for the supply chain, planning and execution of manufacturing site activities from transfer through commercial production, and DP manufacturing site level support of new product launch. To fulfill his role the TLI is a member of several cross functional teams.


(im Bereich Produktion, Produktspezialist/-management, Regulatory Affairs)

Technische Begleitung der Integration neuer Produkte in die bestehenden Abläufe (Technology Transfer Projekte) - Entwicklung und Anwendung von produktspezifischem Wissen speziell unter Berücksichtigung des Zusammenhangs von Produkt und Anlage - Bereitstellung von Expertenwissen für neue Technologien - Proaktives Management des Lebenszyklus neuer und bestehender Produkte - Entwicklung und Anwendung von technischen Standards und Richtlinien für das interne und externe Herstellungsnetzwerk - Führungsstärke in der Umsetzung von Verbesserungsmassnahmen zeigen, unter Berücksichtigung externer beispielhafter und empfohlener Abläufe, um Produktionsausbeuten zu verbessern und Produktionszeiten zu reduzieren


(im Bereich Produktion, Qualitätssicherung/-management, Forschung & Entwicklung)

The function holder is responsible for leadership and strategic direction for the parenteral manufacturing for the clinical supply chain activities based on the Schaffhausen campus, as well as the operational management of the PDMS pilot plant and the outsourced clinical production. The product portfolio includes clinical and commercial drug product as part of the larger drug product clinical supply chain. Integral to the role is the oversight execution and scale up activities necessary to reliably meet demand for clinical materials and to advance drug product commercialization. In order to drive implementation of development standards for the parenteral platform, the function holder will develop strong networks within drug product development and the commercial supply chain and be a key advocate to build the engineering and scientific expertise related to aseptic processing.


(im Bereich Management/Business Development, Produktion, Forschung & Entwicklung)

Sie übersetzen die globale Marketingstrategie des Biomarkersbusiness in den Indikationsbereichen Infektiologie/ Pneumologie für den DACH Markt und verstehen sich als proaktive Unterstützung der Salesteams in allen Marketingthemen auch vor Ort beim Kunden. Ihre Verantwortung: Aufbau und Ausbau von Kommunikationswegen und Mitteln zur zielgerichteten Vermarktung unserer Produkte Erarbeitung und Umsetzung von unterstützenden Materialien für den Verkauf sowie Verkaufstrainings Betreuung von Meinungsbildnern und Kunden im Feld Kontinuierliche Marktanalyse im Indikationsbereich mit Schwerpunkt DACH Region Erstellung von Marketingplänen unter Berücksichtigung der strategischen Unternehmensausrichtung für DACH Konzeptgestaltung für Kongresse und Fortbildungsmaßnahmen


(im Bereich Marketing/Public Relations, Produktspezialist/-management)

Leitung der SGU-Abteilung Leitung der Notfallorganisation (Ereignisdienst, Betriebsfeuerwehr, Betriebssanität) Verantwortung für die betriebseigene Abwasserreinigungsanlage und das Abfallmanagement


(im Bereich Projektmanagement, Qualitätssicherung/-management, Regulatory Affairs, Training / Schulung)

Aim of the Position Responsible for all quality matters related to the activities performed in the production or handling of the assigned products at the site Crucell Berne Assure that assigned products are manufactured according to cGMP requirements Together with the Quality Compliance Team Leader, support operations and / or development with cGMP guidance on all strategic decisions related to the assigned product Duties Support the team leader in his task to ensure that assigned products are manufactured according to cGMP requirement Review and approval of quality documents, Change Controls, event and deviation reports CAPA Management Support Quality Compliance team leader in evaluation of PTCs and ADRs related to the assigned product Support in compilation of the PQRs Establish and update GMP related guidelines and SOP`s Support inspection team during preparation, execution and follow up of inspections and audits


(im Bereich Produktion, Qualitätssicherung/-management)

Support key stakeholders within EMEA businesses with project and improvement activity that supports performance excellence Project management and leadership in transformational improvement projects Manage and support project teams by: aiding the project definition and prioritization process conducting regular reviews and taking action as appropriate providing suggestions and tools that could be adopted undertaking statistical analysis and helping with the interpretation of data providing advice and counsel on the process improvement process (DMAIC) Act as a change agent to help drive improvement within the EMEA, especially on cross-boundary activity Co-ordinate activity relating to common improvement programs (e.g. CIP or 5S) across multiple sites, mainly in Switzerland and Germany. Facilitate/lead group sessions Coach and mentor individuals participating or leading improvement activity Deliver training on continuous improvement related topics Provide technical expertise to internal and external customers as requested Spread best practice and proven improvement activity with relevant stakeholders


(im Bereich Management/Business Development, Projektmanagement, Technischer Service / Kundenservice)

Accountability for meeting new business targets Territory anaIysis and identification of new clients within the given territory Analysis of clients‘ clinical trial pipelines / requirements Generation of fully costed, commercially viable, clinical supply chain solutions Management of contractual processes / agreements Project handover to the service delivery groups/project management Reporting/provision of account status reports Continuous improvement thinking to improve customer satisfaction


(im Bereich Management/Business Development, Verkauf / Vertrieb)

Biomolecular Interactions in Basic Research, Biotechnology and Pharmaceutical Industry Locations: Munich based, Territory: Europe COMPANY NanoTemper Technologies develops, produces and sells innovative instruments for the field of biomolecular interaction analytics serving basic research as well as industry. The company, with headquarters in Munich, Germany, is rapidly expanding globally. The high quality instruments are based on the proprietary and unique Microscale Thermophoresis (MST) technology. NanoTemper successfully introduced the Monolith NT.115 instrument in Europe, North America and Asia in 2010. In summer 2012 a new instrument, the Monolith NT.LabelFree has been introduced. To meet the increasing demand for sales and support in the european market, the company is expanding its sales force. We are searching for Sales Representative and Field Application Specialist. RESPONSIBILITIES As a member of our dynamic, international sales team, you will be supporting pre- and post-sale technical activities in the European market. Your responsibilities include: Finding high potential, customer, explain customers the MST theory, demonstrate applications with customer samples and finalizing of sale.  Participation at international trade fairs is an important part of your responsibilities. POSITION REQUIREMENTS PhD degree in Biochemistry, Biophysics, Biology, Molecular Biology, or a related field. PhD is strongly preferred. 3 years or more of experience is a plus. Excellent technical skills and experience in state-of-the-art biomolecular interaction technologies are important. Excellent experimental skills for setup of biomolecular interaction assays are crucial. Ability to navigate accounts in broad geography effectively and advance the capital equipment process consistently is very important. An excellent ability to work independently, with strong communication skills and networking ability is a merit for this position. Highly proficient experimental and organizational skills, ability to manage multiple simultaneous experiments and ability to travel 60% with multiple overnight stays are required. WORKING CONDITIONS Travel will be required (60%). The employee must occasionally lift heavy items. Location: Munich based, territory Europe. We offer competitive compensation, a thrilling technology platform and the opportunity to be a part of and contribute to a dynamic and growing team. APPLICATIONS: Please send your resume via E-mail to job@nanotemper.de CONTACT Dr. Stefan Duhr NanoTemper Technologies GmbH (www.nanotemper.de) Floessergasse 4 81369 Munich Email: job@nanotemper.de Phone: +49 (0)89 45 22 895-0


(im Bereich Verkauf / Vertrieb, Training / Schulung, Technischer Service / Kundenservice)

Als Fachspezialist/ in Safeguards repräsentieren Sie die Schweiz und sind verantwortlich für die nationale Aufsicht über Kernmate­rialien, die der Kontrolle der IAEA unterstehen. Ihnen obliegt die Leitung von nationalen Inspektionen. Sie führen die nationale Kernmaterial-Buchhaltung und erstellen Berichte an die IAEA. Sie bearbeiten Anfragen zur Exportkontrolle und wirken als Vertreter/ in des Amtes in der Exportkontrollgruppe des Bundes mit. Ferner sind Sie Ansprechperson für Fragen im Bereich Kern­brennstoffkreislauf und Nukleartechnologie und sind an der Aus­arbeitung von Antworten auf parlamentarische Anfragen im Kernenergiebereich beteiligt.


(im Bereich Qualitätssicherung/-management)

Planning and performance of process development, scale up and manufacturing of CTM material under GMP within the downstream processing unit Establishment and Review of process related documents (Batch Records, Standard operation procedures, Reports,…) Sample organization within the Downstream Processing (DSP) area including reception and evaluation of data Taking over of Room and Equipment Responsibilities Planning and performance of process support activities (buffer preparation, equipment preparation, autoclaving, waste removal) Support Qualification and Validation activities related to DSP processes, equipment, rooms Taking over of assigned projects within the DSP area


(im Bereich Produktion, Forschung & Entwicklung)

Responsible for the safe and on-time delivery of investment (sub-)projects of up to approximately €1 million Responsible for preparing the users´ functional and technical requirements and support Procurement in negotiations with contractors and vendors Prepare cost estimates, vendor quote analyses together with Procurement Create purchase requisitions and process invoices Supervise construction and machine installation (at supplier, on site) Responsible vendor follow-up, clearance for shipment (FAT), and site acceptance (SAT) Responsible for organising the commissioning and qualification Prepare project reports on progress, issues, cost, and hours consumed Support in the preparation of operating and maintenance instructions and procedures within the realm of the project Prepare technical documentation for hand-over to Maintenance Dept.


(im Bereich Projektmanagement)

Verantwortung für das Lieferanten-Qualifizierungssystem Qualifizierung neuer und bestehender Lieferanten Überwachen und bewerten von kritischen Lieferanten Planung, Durchführung und Nachbearbeitung von Lieferanten-Audits Erstellung und Vereinbarung von Qualitätssicherungs-Vereinbarungen Verantwortung für das Lieferantenreklamationswesen Unterstützung des Einkaufs, AVOR und Entwicklung bei Spezifikations-Vereinbarungen mit Lieferanten Führen und regelmässiges Berichten der relevanten Kennzahlen Durchführen von internen Audits


(im Bereich Qualitätssicherung/-management)