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.
Responsabilit\\xc3\\xa9s
Act as a single point of contact for inquiries from other BBIO functions concerning his components
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
Qualifications
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