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Principal Scientist IVT Drug Product Development(m/w/x)
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
- English – Fluent
- German – Fluent
Tools & Technologies
- IVT
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Principal Scientist IVT Drug Product Development(m/w/x)
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
- English – Fluent
- German – Fluent
Tools & Technologies
- IVT
About the Company
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
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- Boehringer Ingelheim
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Praktikum Stöchiometrische Modellierung von Säugetierzelllinien in der pharmazeutischen Entwicklung(m/w/x)
Full-time/Part-timeInternshipOn-siteBiberach - tw.con. GmbH
Apotheker(m/w/x)
Full-time/Part-timeOn-siteNot specifiedNeuried - Viselle Augenzentrum Erlangen GmbH
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Full-time/Part-timeOn-siteExperiencedEttenheim