Manager(f/m) Combination Product Development & External opportunities
Boehringer Ingelheim
Ingelheim, Palatinate, Rhineland, DE
vor 8 Tg.

Manager(f / m) Combination Product Development & External opportunities-1814659

As Manager for Drug-Delivery Device Development you lead internal and external sub-teams (project leadership, no direct reports) for the device development of biopharmaceutical combination products (CP) and parenteral drug-

delivery technologies, also with a focus on external opportunities including digital health.

Tasks & responsibilities

  • 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 decision 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.

    Moreover, you work on early stage technology exploration and resulting external opportunities, especially in the electronics and digital health space (software and hardware)

    Requirements

  • PhD or master's degree in pharmacy, engineering or IT
  • At least 5 years experience in the medical device industry for biopharmaceutical drug-delivery devices, combination products and digital health is required
  • Experience in manufacturing, automation, electronics and digital applications is of advantage. Experience with in-vitro diagnostics, especially electronics based is also welcome
  • Additional experience with coordination of activities at third party manufacturers, vendors and service provides is preferred (purchasing controls)
  • Broad expertise around regulatory requirements for parenteral combination products is preferred (mainly 21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366 and other guidelines for CP development and required quality system regulations).
  • Experience with regulatory requirements for In-Vitro Diagnostics, software as a medical device, electronics (e.g. IEC 62304 & 60601) would be a plus

  • Fluent in English with excellent organization and communication skills as well as sound technical writing and documentation competencies
  • Our benefits

  • Good compatibility of work and private life
  • Good development opportunities with in-house education and various training options
  • Gym and variety of company sports groups
  • Health center with occupational medicine
  • Competitive salary plus bonus payments
  • Who we are

    At Boehringer Ingelheim we create value through innovation with one clear goal : to improve the lives of patients. 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 are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture.

    Learning and development for all employees is key, because your growth is our growth.

    Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

    We look forward to receiving your online application!

    Contact

    For further information please contact Recruiting Services :

    Mrs. Susann Voigtländer, Tel : +49 (0) 6132 77 142235

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  • Research & Development
  • Primary Location

  • Europe-DE-Rhineland-Palatinate-Ingelheim
  • Organization

  • DE-Boehringer Ingelheim Pharma GmbH&Co.KG (Germany)
  • Full-time
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