Senior Manager Life Cycle Project Management (m/f/d)

14.04.2021

Daten dieser Anzeige

Job-ID: 021229942
Senior Manager Life Cycle Project Management (m/f/d)

Fresenius Kabi

Germany

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Manage Life Cycle and Insourcing activities for the FKSBS Biosimilar portfolio: Manage LCM and Insourcing meetings Ensure visibility of plans and changes of all LCM and Insourcing activities Ensure detailed timelines and budgets are established and respected through negotiation with project stakeholders Coordinate with functions leads (RDMS, Quality, Regulatory Affairs, IP, Sites functions) to ensure timely execution of work packages Establish & manage LCM and insourcing documentation (work-package reports, minutes of internal and external meetings, risk assessments) Act as point of contact for Insourcing & LCM activities Support the organization in the setup of LCM activities with external partners (SoWs, budgets, SME review) Support functions in defining the LCM and insourcing strategy and related stakeholder management Manage LCM budget (actuals, accruals, forecast, short & long term planning): Work in close collaboration with the controller Provide LCM and Insourcing teams with early warnings on possible budget variances. In case of major variations inform team according to established governance guidelines Challenge team members on their functional project activities to ensure efficient and cost conscientious development Create state-of-the-art project management tools for LCM and insourcing activities (budget, KPIs and resource mapping) Other relevant activities as required

About Fresenius / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Senior Manager Life Cycle Project Management (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. Your assignments Manage Life Cycle and Insourcing activities for the FKSBS Biosimilar portfolio: Manage LCM and Insourcing meetings Ensure visibility of plans and changes of all LCM and Insourcing activities Ensure detailed timelines and budgets are established and respected through negotiation with project stakeholders Coordinate with functions leads (RDMS, Quality, Regulatory Affairs, IP, Sites functions) to ensure timely execution of work packages Establish & manage LCM and insourcing documentation (work-package reports, minutes of internal and external meetings, risk assessments) Act as point of contact for Insourcing & LCM activities Support the organization in the setup of LCM activities with external partners (SoWs, budgets, SME review) Support functions in defining the LCM and insourcing strategy and related stakeholder management Manage LCM budget (actuals, accruals, forecast, short & long term planning): work in close collaboration with the controller Provide LCM and Insourcing teams with early warnings on possible budget variances. In case of major variations inform team according to established governance guidelines Challenge team members on their functional project activities to ensure efficient and cost conscientious development Create state-of-the-art project management tools for LCM and insourcing activities (budget, KPIs and resource mapping) Other relevant activities as required Your profile Qualification profile:  B.Sc., M.Sc., PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline Minimum 7 years of relevant biologics R&D and/or CMC experience in a Pharma/Biotech industrial setting Experience in biosimilar development and/or commercialization is a plus Strong project management skills and master state-of-the-art multi-projects & program management tools & techniques Competencies: excellent planning and organizational skills, excellent communication skills, customer orientation, problem analysis and solving, results-oriented, teamwork-oriented Familiarity with current GMP guidelines Some knowledge and/or exposure to regulatory requirements and submissions (IMPD/IND/BLA) and quality requirements from the industry (GMP; FDA; ICH) Experience with managing and overseeing a budget Practical experience or theoretical knowledge in some of these fields would be a strong asset: process development, analytics, technology transfer, process scale up, process validation, GMP manufacturing in the Biotech industry Fluent English is required; French is an asset Apply now  Share by email  Print this page Your Contact Svenja Reith Fresenius Kabi SwissBioSim GmbH Ref. number: 43165>  fresenius-kabi.com At a glance Career level: Professional Experienced Job category: Project Management Working condition: Permanent / Part-time Business segment: Fresenius Kabi Location: Eysins / International Closing date for applications: none - we look forward to your application About Fresenius Over 300,000 people across the globe work at Fresenius to provide better medicine for 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.>  career.fresenius.com >  fresenius.com One of Fresenius' strengths: our corporate culture for "entrepreneurs in an enterprise" where you can quickly take on responsibility. The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. >  More reasons >  More benefits Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png 2021-06-12T14:26:34.062Z FULL_TIME YEAR null Eysins 1262

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Forschung & Entwicklung

Sonstige Branchen

Medizintechnik/ Optik

Projektleitung/ Stabstelle/ Spezialist

Vollzeit