We have a clear commitment: putting best-possible solutions in the hands of medical profes
sionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations. Around the world, all of us are committed to our shared endeavor: caring for life.
…+ <- Eysins · Full-time · As of now Senior Manager Analytical Method Transfer (m/f/d) With our corporate philosophy of «caring for life», we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face. In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients. Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer. Your assignments Functional Goal: Coordinate the physicochemical assays transfers, establishment and project monitoring from beginning to end between the transferring and the receiving laboratories of Drug Substance (DS) manufacturing sites Guide cross-functional teams within different geographies and companies and foster collaboration to achieve results on time CMC member of the Product Team(s) responsible for the technical aspects of compliant analytical method transfers during late-development or commercial phase Main Tasks: Establish product-specific analytical tech transfer strategy and plans with tech transfer team Oversee and guide analytical method transfer activities: Team composition definition, transfer of documentation, knowledge transfer from donor site to receiving site including analyst training, feasibility experiments, risk / gap assessment, analytical method transfer protocol, experimental execution according to method transfer approach, evaluation of results, reporting, troubleshooting Assist in definition of site resource needs and get management approval via global technology transfer manager for the analytical transfer costs (e. g. FTEs, reagents costs, investments and external costs), strategies and timelines Ensure timely availability of technical documentation pertaining to analytical transfers. Review analytical methods transfer documents as well as key project documents and coordinate technical input in relevant registration documents for accuracy and completeness as appropriate Track the progress and openly communicate updates, risks and mitigation strategies, build and sustain transparency with stakeholders and management Ensure that Fresenius Kabi guidelines, Health Authority and GMP guidelines are met Travel (15-20 %) is expected between the different FK & CMO sites Other Tasks: Initiate and own change control for method transfers. Assist CAPA and root case analysis / investigations as a technical subject matter expert Align on dossier updates with CMC Regulatory Affairs Your profile Education: Preferably PhD - otherwise Master - in biochemistry, biotechnology, pharmacy, biophysics or similar Languages: Fluency in English. Fluency / strong proficiency in Spanish would be a plus. French would be an asset Work experience: Minimum 8 years driving analytical tech transfer of in-house and compendial methods for commercial products in highly regulated markets Job Specific Competencies & Skills: Strong background in analytical science for biologics with a focus on physicochemical analytics Good understanding of cGMP requirements, audits and Health Authorities (HA) interactions Be a conductor of activities and must have the skills to influence indirectly the project teams, manage international interactions, and able to interact with technicians understanding their needs and anticipating issues in the process. The person is an individual contributor; but also, must manage a wide project team comprehensive of various internal and external stakeholders in various countries (mainly Switzerland, Italy, Spain and/or Argentina) Skilled problem solver Good interpersonal, networking and teamwork skills Excellent organizational and time management skills Proactive work style Career level: Professional Experienced Job category: Research & Development Working condition: Permanent / Full-time Business segment: Fresenius Kabi Location: Eysins / International Closing date for applications: none - we look forward to your application Apply now Share this job Print this Page Your Contact Elisa Arnaud Fresenius Kabi SwissBioSim GmbH Ref. number: 54727 At a glance Career level: Professional Experienced Job category: Research & Development Working condition: Permanent / Full-time Business segment: Fresenius Kabi Location: Eysins / International Closing date for application: none - We are looking forward to your application More information Information about the application process Our offer at a glance We welcome diversity At Fresenius all job applicants are welcome - regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics. All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse). All references to persons in this job advertisement apply equally to all genders (male, female, diverse). #careerswithapurpose at Fresenius Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png 2023-03-14T11:07:58.900Z FULL_TIME EUR YEAR null 2023-01-13 Eysins 1262 46.381576 6.2088848