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)
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
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!
For further information please contact Recruiting Services :
Mrs. Susann Voigtländer, Tel : +49 (0) 6132 77 142235
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Research & Development
DE-Boehringer Ingelheim Pharma GmbH&Co.KG (Germany)