Project Lead Combination Product Development

☞ Boehringer Ingelheim

Vue: 170

Jour de mise à jour: 07-10-2024

Localisation: Ingelheim am Rhein Rhineland-Palatinate

Catégorie: Production/Opération Marketing / RP

Industrie: Pharmaceutical Manufacturing

Niveau: Mid-Senior level

Type d’emploi: Full-time

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le contenu du travail

Our CompanyAt Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.Tasks & Responsibilities



  • As a Lead of a device team, you are accountable for the development of a Combination Product.
  • You apply excellence in project management along the BI internal design control process to achieve development and submission in the target timeframe, in compliance with global budget requirements.
  • You plan and execute drug-delivery technology development projects in cooperation with external suppliers in time and budget.
  • Utilizing your expertise, you provide technical and project related presentations to internal and external project teams and steering committees.
  • You are part of contract negotiations with external partners for drug delivery technologies and together with subject matter experts you manage internal and external technology developments.
  • Together with subject matter experts, you ensure the compliance to internal and external regulations (US, EU) for drug delivery devices/combination products. You support and represent drug-delivery technology strategies in meetings with regulatory authorities when required.
  • If necessary, you author, contribute, review and approve relevant design control, risk management and usability engineering documentation.
  • You contribute with your experience to further improve and strengthen all structures and processes underlying a state-of-the-art drug delivery technology development, manufacturing and life-cycle management.
  • You are part of an agile team, always striving for excellence in project management and combination product development.

Additional tasks for the Manager role:



  • You provide scientifically sound and compliant proposals, concepts and results for the integration of combination product development in the overall project strategy, with the aim of a successful submission and approval of the Combination product.
  • You provide strategic concepts for Combination Product and device platform development to decision making committees.

Requirements



  • Master´s degree or PhD in Life Science, Pharmacy or Engineering
  • Comprehensive knowledge of internal quality procedures in pharma industry
  • Sound knowledge of Medical Device, Combination Product regulatory or development function
  • Strong project management skills for pharmaceutical development programs with a focus on Combination Products incl. management of complex teams and topics
  • Highly self-organized, solution oriented and proactively communication skills with a strong decision- making mentality
  • Fluent in English (both written and spoken)

Additional Requirements for Manager role:



  • Proven experience in Medical Device or Combination Product regulatory or development function

WHY BOEHRINGER INGELHEIM?This is where you can grow, collaborate, innovate and improve lives.We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area .Want to learn more about us? Visit https://www.boehringer-ingelheim.com/Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.READY TO CONTACT US?Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.JobResearch & DevelopmentPrimary LocationEurope-DE-Rhinland-Palatinate-IngelheimOrganizationDE-Boehringer Ingelheim Pharma GmbH&Co.KG (Germany)ScheduleFull-time
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Date limite: 21-11-2024

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