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Bruker Coorporation\\xe2\\x80\\x99s companies belong to the world\\xe2\\x80\\x99s leading analytical and measuring instrumentation manufacturers in the sector of life sciences. For the last 60 years Bruker has been fulfilling one single purpose: to deliver the best technological solution. Today, more than 8,500 employees worldwide are working on this challenge, in over 90 locations in all continents.

Bruker BioSpin, as part of the Bruker Group, is a high-tech international company and the world-leading manufacturer of comprehensive solutions in Nuclear Magnetic Resonance (NMR), Electron Paramagnetic Resonance (EPR) and Preclinical Magnetic Resonance Imaging (MRI).

For our office in Faellanden, we are searching for a Component Manager for NMR Reference Samples and Consumables (a)

As our Component Manager you will hold responsibility for all technical and regulatory aspects related to the life cycle of products within his/her portfolio. You will act as project manager for component development projects. For larger projects, you will have access to Project Managers who are responsible for ensuring that projects are carried out on-time, on-cost and on-spec, however the CM remains ultimately responsible for the realization and outcome of projects and remains responsible for the technical aspects of the component (modifications, improvements, obsolescence issues) throughout the lifecycle of a component. You will be responsible for required handshakes (and escalations) between Product Development and the divisional MM (Market Manager), PM (Product Manager), Service, Operations (Logistics, Procurement, Production) and Quality & Regulatory. Since products in the CM\\xe2\\x80\\x99s portfolio may be used in more than one division, you will align with other TPMs in order to identify synergies and design reuse at system level across product lines.

Aufgaben/Verantwortlichkeiten

• Act as a single point of contact for inquiries from other BBIO functions concerning his components
• Represent sample perspective in PLM & non-PLM R&D activities (e.g., product development, stage-gate process)
• Establish effective and efficient collaboration mechanisms for stakeholder management across divisions (PMs, MMs, Service, etc.) and other functions (Operations, Purchasing, Q&RA etc.)
• Define specs (raw materials, composition & tube), balancing manufacturability and NMR requirements resp. properties; incl. labelling and packaging, certifications and traceability (strong interface to Application Science and Development)
• Ensure implementation of Q&RA compliance strategy and inputs by executing all national & international legally required notifications and information, with signature authority
• Ensure pragmatic handling of milestones within the R&D stage-gating process, based on regulatory requirements and product type;
• Ensure a comprehensive configuration and version management for the product line

Asigned Products:

• Sample kits, calibration and reference samples across BBIO instrument portfolio using samples, from liquid and solid state NMR to CMR and EPR.
• Focus on developing new sample kits and (Bio-)Fluids in a GLP environment incl. buffer solutions, calibration and reference samples in B2B and potential future B2C (eHealth)
• NMR Consumables including sample containers (glass tubes and rotors), sample caps, sample holders and racks

Additional Information:

• Reference sample production labs in Switzerland and Germany
• Strong interface with Application Science for reference sample validation
• Profound knowledge on the methods and technologies used within assigned product lines
• Profound understanding and experience in the R&D product development process
• Special focus on of regulatory compliance and manufacturability

Qualifikationen

• Sc. and / or M.Sc. in chemistry or bio & life sciences
• Relevant trainings in GxP and compliance
• Minimum of 3 years professional experience in Component development and /or technical Product Management
• Demonstrated relevant expertise in regulatory compliance
• Excellent knowledge and professional experience on product life cycle management, with a focus on validation with application scientists
• Good knowledge in SAP
• Fluent written and spoken technical English skills (German language skills are beneficial)
• Ability to lead by example and with integrity
• Strategic and analytical thinking
• Focused and decisive working attitude
• Takes clear ownership for the product domain
• Time and self-management
• Team player in the organization
• Open, constructive and direct communication
• High degree of identification with the organization and its targets

Bruker is an equal opportunity employer. We evaluate qualified applicants based on their skills, experience, and qualifications, without regard to race, colour, religion, sex, national origin, disability, age, sexual orientation, gender identity, or any other protected characteristic. We are committed to creating a diverse and inclusive workplace and encourage applications from candidates of all backgrounds.

Please note that we only accept online applications.\\n \\n \\n \\n \\n \\n

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