Senior Expert (m/f/d) R&D Developability and Formulation
Job ID: 62794
Location: Heidelberg, DE
Job Level: Professionals
Job Category: Research and Development
Employment Type: Permanent position

Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

Octapharma Biopharmaceuticals GmbH with more than 200 employees is a subsidiary of the Octapharma group founded in 1997 and successfully expanding. Our core business is the development of recombinant proteins produced in human cell lines for therapeutic use in humans. We strive for effective treatments with an improved tolerability and convenience for our patients.

Join us in shaping our vision to provide new health solutions advancing human life.

We are looking for a Senior Expert (m/f/d) to join our state-of-the-art R&D Developability and Formulation group in Heidelberg. In this role, you will be responsible for developing robust drug product formulations for protein therapeutics from early development through clinical stages.
You will lead formulation strategy and development activities for injectable biologics, including liquid and lyophilized products, while supporting CMC and regulatory activities. Working closely with cross-functional teams and external partners, you will help advance our pipeline and contribute to next-generation drug product and delivery technologies.
Develop and define formulation strategies for protein drug candidates across all development stages, including stability assessment, excipient selection, and container-closure compatibility
Lead formulation development programs, taking strong scientific ownership and coordinating external partners (e.g., CROs and CDMOs), while ensuring cross-functional alignment and data-driven decisions
Plan, design, conduct, and critically review complex experimental studies, integrating advanced and risk-based approaches (e.g., DoE, QbD, stability modeling)
Support scale-up and technology transfer to clinical manufacturing, ensuring robust translation into GMP production with internal teams and external partners
Playing a leading role in CMC activities, including authoring, reviewing, and shaping documentation for regulatory submissions
Drive innovation by leveraging scalable approaches, device and packaging solutions, and emerging technologies
Mentor colleagues and contribute to scientific excellence, knowledge sharing, and continuous improvement
Actively contribute to the department’s scientific goals, innovation efforts, and cross-functional discussions, with a proactive and collaborative mindset

PhD or MSc in Pharmaceutical Sciences, Biochemistry, Chemistry, or related field, with proven industry experience in biologics formulation development
Proven track record of advancing protein formulations through clinical development, ideally including late-stage or commercial products
Strong expertise in parenteral formulations, including formulation design and excipient selection
Experience in development subcutaneous drug product and lyophilization development is a strong plus
Solid background in data-driven formulation development, applying DoE and QbD principles, with hands-on experience in biophysical and analytical characterization
Sound understanding of ICH/GMP requirements and experience preparing CMC documentation for regulatory submissions (e.g., IND, CTA, BLA/MAA)
Strong ability to drive scientific decisions, collaborate effectively in cross-functional teams (e.g., Analytics, Pilot Production, CMC/Regulatory stakeholders), and operate in a dynamic R&D environment
Experience in advanced drug delivery approaches (e.g., oral delivery, sustained-release systems) is considered a plus

A permanent...