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

Octapharma-Plasma; Heidelberg; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Modern workspace

Training opportunities

30 days vacation

Restaurant on-site with subsidies

Free beverages

Commuter support

International team

Collaborative culture

Zusammenfassung

Octapharma Biopharmaceuticals GmbH in Heidelberg is seeking a Senior Expert (m/f/d) to join the 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

Qualifikationen

• 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 hand-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

Aufgaben

• 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

Kenntnisse

Protein formulation

Parenteral formulations

DoE & QbD

Cross-functional collaboration

Data-driven formulation

Biophysical characterization

Regulatory awareness

Advanced drug delivery

Ausbildung

PhD or MSc in Pharmaceutical Sciences, Biochemistry, Chemistry, or related field

Jobbeschreibung

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

Job ID: 62794

Location: Heidelberg, DE

Job Level: Professionals

Job Category: Research and Development

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.

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 hand-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

It´s in our blood

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.

Do you have any questions? Then get in touch with your contact person.

Dorothee Schaupp

Octapharma Biopharmaceuticals GmbH

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 200 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.