Senior Principal Scientist Ocular Drug Delivery/IVT Full-time

Senior Principal Scientist Intravitreal Dosage Forms

Join our dynamic Development Team for intravitreal dosage forms (IVT) at Boehringer Ingelheim's Biberach site as a Senior Principal Scientist! You'll play a pivotal role in the people's leadership and in parallel 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. 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 scientific people leadership and in parallel 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 open for a hybrid setup with at least 2-3 days per week on site.

Tasks & Responsibilities

In your new role, you will:

• Develop strategic concepts for formulation and analytical development of extended-release ocular Drug Delivery dosage forms.
• Lead the full end-to-end development from early formulation feasibility concept, through scale-up, transfer, validation and registration work packages.
• Develop and implement strategies for formulation development, including scouting and implementing innovative formulation and process technologies.
• Manage external collaborations with CDMOs for the development of formulations and innovative technologies as well as 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.
• 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.
• Prepare, review, and approve manufacturing documentation, specifications, internal CMC reports, and SOPs.
• Contribute to regulatory submissions (IMPD/IND, MAA), respond to health authority queries, and support patent applications in collaboration with the intellectual property department.
• Drive innovation by scouting and implementing cutting edge technologies, leading scientific collaborations, enabling internal scientific training, and advising on complex development challenges.
• Actively contribute to Boehringer's internal scientific network by fostering cross-functional knowledge exchange, and furthermore represent the company externally through collaborations with authorities, partners, and scientific organizations while initiating and leading scientific exchange forum.

Requirements

We are looking for a candidate with:

• PhD in pharmaceutical technology with long-standing (minimum 10 years) scientific experience for pharmaceutical development especially with a focus on ocular drug delivery technologies with sustained release.
• Deep expertise in PLGA polymer selection and characterization as well as in biopharmaceutical development aspects like in vitro – in vivo relationship/correlation.
• Deep expertise in end-to-end development from early formulation feasibility concept, through scale-up, validation, regulatory aspects and registration work packages paired with deep expertise in rational formulation design (e.g., DoE and QbD).
• Good knowledge in MS-Office as well as common laboratory software.
• Highly motivated and well-organized team player with excellent communication, presentation, and problem-solving skills, with strength in leading and collaborating in interdisciplinary teams with a strong focus on finding solutions within project timelines.
• High problem-solving competence for technical and organizational challenges.
• Fluent in English for handling a multitude of interfaces, as well as sound technical writing and documentation competencies in English.

Ready to contact us?

If you have any questions about the job posting or process – please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com