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BOBoehringer Ingelheim

Principal Scientist IVT Drug Product Development(m/w/x)

Biberach
Part-timeOn-siteExperienced

Optimizing manufacturing processes for extended-release ocular dosage forms and IVT systems for human and animal health, including DOE-based screenings. PhD in pharmaceutical technology and IVT long-acting dosage form knowledge essential. International project team collaboration.

Requirements

  • PhD in pharmaceutical technology or related discipline
  • Several years of relevant professional experience
  • Experience in partial project leadership in matrix organization
  • Knowledge of long-acting dosage form development (preferably IVT), biodegradable polymers, and API solid-state behavior
  • Advantageous expertise in biopharmaceutical development (in vitro – in vivo relationship/correlation)
  • Comfort with uncertainties of innovative drug delivery dosage forms
  • Technical writing and documentation competencies in English
  • Fluent English and German
  • Experience in project leadership in matrix organization
  • Asset: International exposure
  • In-depth knowledge of long-acting dosage form development (preferably IVT), biodegradable polymers, and API solid-state behavior
  • Advantageous deep expertise in biopharmaceutical development (in vitro – in vivo relationship/correlation)

Tasks

  • Develop extended-release ocular dosage forms.
  • Coordinate and plan pharmaceutical technologies for sustained-release formulations.
  • Conduct DOE-based formulation screenings.
  • Optimize, implement, and characterize manufacturing processes for IVT systems.
  • Represent the DPC department in international project teams.
  • Plan, execute, and coordinate pharmaceutical development for NCE projects.
  • Manage external collaborations for formulation development.
  • Manage external collaborations for technology development.
  • Coordinate DPC functions to achieve milestones and deliverables.
  • Apply QbD and QRM principles throughout development.
  • Scout and implement cutting-edge technologies.
  • Lead scientific collaborations.
  • Enable internal scientific training.
  • Advise on complex development challenges.
  • Prepare, review, and approve manufacturing documentation.
  • Prepare, review, and approve specifications.
  • Prepare, review, and approve internal CMC reports.
  • Prepare, review, and approve SOPs.
  • Contribute to regulatory submissions (IMPD/IND, MAA).
  • Support patent applications with intellectual property.

Work Experience

  • approx. 1 - 4 years

Education

  • Doctoral / PhD

Languages

  • EnglishFluent
  • GermanFluent

Tools & Technologies

  • IVT
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