Senior Expert (m/f/d) R&D Developability and Formulation

Octapharma AG; Heidelberg; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

30 days vacation

Modern working environment

Ongoing training

Restaurant with subsidies

Free drinks (coffee, tea, water)

Job ticket or parking

International team

Collegial environment

Zusammenfassung

Octapharma AG in Heidelberg is seeking a Senior Expert (m/f/d) to join our R&D Developability and Formulation group. You will be responsible for developing robust drug product formulations for protein therapeutics from early development through clinical stages.

The role combines leadership of formulation programs, external partner coordination, and data‑driven decision making in a GMP/CMC context, with a strong focus on innovation and collaboration.

Qualifikationen

• PhD or MSc in Pharmaceutical Sciences, Biochemistry, Chemistry, or related field with industry experience in biologics formulation development.
• Proven track record advancing protein formulations through clinical development.
• Strong expertise in parenteral formulations and excipient selection.
• Experience with subcutaneous formulations and lyophilization a plus.
• Hands-on in DoE and QbD, and biophysical/analytical characterization.
• Knowledge of ICH/GMP; experience with regulatory CMC submissions (IND/CTA/BLA/MAA).
• Ability to drive decisions in cross-functional teams and external partnerships.
• Experience with advanced drug delivery approaches is a plus.

Aufgaben

• Develop and define formulation strategies for protein drug candidates across development stages.
• Lead formulation programs, coordinate CROs/CDMOs, and ensure cross‑functional alignment.
• Plan and review complex experimental studies using DoE/QbD and stability modeling.
• Support scale‑up and tech transfer to GMP production with internal and external teams.
• Contribute to CMC regulatory submissions and documentation.
• Drive innovation in formulation, device/packaging solutions, and new technologies.
• Mentor colleagues and promote scientific excellence and continuous improvement.
• Engage in departmental goals and cross‑functional discussions with a collaborative mindset.

Kenntnisse

Formulation development

DoE / QbD

Parenteral formulations

Lyophilization

Data-driven development

ICH / GMP knowledge

Cross-functional collaboration

Regulatory documentation

Ausbildung

PhD in Pharmaceutical Sciences / Biochemistry / Chemistry

MSc in related field

Tools

DoE software

Statistical software (JMP/Minitab)

Biophysical characterization tools

Jobbeschreibung

Job ID: 62794

Location: Heidelberg, DE

Job Level: Professionals

Job Category: Research and Development

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.

Your main tasks and responsibilities

• 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

Your expertise and ideal skill set

• 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

Thrive with us

• A permanent position in full‑time (40 hrs./week) in a dynamically growing company
• A modern, state‑of‑the‑art working environment
• Regular opportunities for further training
• 30 days vacation
• Own company restaurant with subsidies
• Free drinks such as coffee, tea and water
• Job ticket or parking space for bicycle or car
• An international team in an international corporate environment
• A collegial environment with many opportunities for activities

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application – regardless of age, gender, origin, sexual orientation, and religion. We explicitly welcome applications from people with severe disabilities and those with equivalent status.