Principal Scientist IVT Drug Product Development Part-time NEW

The Position

Join our dynamic Development Team for intravitreal dosage forms (IVT) at Boehringer Ingelheim's Biberach site as a Senior Scientist or Principal Scientist. You'll play a pivotal role in the development of groundbreaking ocular Drug Delivery Technologies, contributing to the entire drug product development cycle of the Therapeutic Area Mental Health, Eye Health and Emerging Areas. Your work will directly impact patient care, tailoring our products to their needs. This role will offer you an exceptional opportunity to broaden your professional horizon, gain valuable experience in the global New Chemical Entities (NCE) development, and work in intradisciplinary CMC teams. Embrace new challenges and deepen your insights into innovative formulation approaches with us!

This position is part time eligible with 80%.

Tasks & Responsibilities

In your new role, you will develop extended-release ocular Drug Delivery dosage forms for clinical trials and toxicological studies.

You will coordinate and plan state-of-the-art pharmaceutical technologies for sustained-release formulations (e.g., hot melt extrusion, co-extrusion, spray drying), including DOE-based formulation screenings.

You will optimize, implement and scientifically characterize manufacturing processes for intravitreal drug delivery systems, e.g., automation or semi-automation of manual manufacturing processes.

Additional Tasks for Principal Scientist

• You will represent the Department Drug Product Development NCE (DPC) as Team Member Drug Product in international project teams, responsible for planning, execution, and coordination of pharmaceutical development activities for NCE projects.
• In addition, you will manage external collaborations with CDMOs for the development of formulations and innovative technologies.
• You will coordinate all involved functions within DPC, ensuring timely achievement of project milestones and deliverables while applying Quality by Design (QbD) and Quality Risk Management (QRM) principles throughout product and process development.
• Furthermore, you will drive innovation by scouting and implementing cutting edge technologies, leading scientific collaborations, enabling internal scientific training, and advising on complex development challenges.
• Moreover, you will prepare, review, and approve manufacturing documentation, specifications, internal CMC reports, and SOPs. You will also contribute to regulatory submissions (IMPD/IND, MAA), and support patent applications in collaboration with the intellectual property department.

Requirements

• PhD in pharmaceutical technology or related discipline with several years of relevant professional experience.
• Experience in partial project leadership within a matrix organization
• Knowledge on long-acting dosage form development (preferably IVT), biodegradable polymers and solid-state behavior of APIs in processed polymers.
• Expertise in biopharmaceutical development aspects like in vitro – in vivo relationship/correlation is an advantage.
• You should feel comfortable with the uncertainties of highly innovative and cutting-edge drug delivery dosage forms.
• Technical writing and documentation competencies in English.
• Fluent in English and German for handling a multitude of interfaces.

Additional Requirements for Principal Scientist

• Experience in project leadership within a matrix organization, with international exposure considered an asset.
• In-depth Knowledge on long-acting dosage form development (preferably IVT), biodegradable polymers and solid-state behavior of APIs in processed polymers.
• Deep Expertise in biopharmaceutical development aspects like in vitro – in vivo relationship/correlation is an advantage.