Juridische vacatures Barneveld

Director, Biologics – Formulation, Safety & Performance (Combination Products)

Department: Research
Reports to: VP R&D
Location: Bilthoven, The Netherlands
Fulltime

About Kuros Biosciences

Kuros Biosciences is a Swiss‑listed life science company specializing in orthobiologics for spinal fusion surgery. With locations in Switzerland, the USA, and the Netherlands, we manufacture our bone repair products in Bilthoven and sell them worldwide. We are seeking an experienced RA Officer to join our growing team in Bilthoven.

Position overview

We are seeking an experienced Director of Biologics to lead early formulation development for implantable combination products containing biologically active components.

In this role, you will define and execute the feasibility program from concept through proof‑of‑performance, ensuring that formulations are compatible with device materials, safe for intended use, and capable of delivering the required biological effect.

This position requires deep expertise in biomaterials, biocompatibility & safety, release kinetics, and combination products, combined with strong cross‑functional leadership across engineering, regulatory, clinical, and quality teams.

Key Responsibilities 1. Formulation Strategy & Development

You will lead the scientific direction and feasibility work for biologic formulations used in implantable or device‑integrated delivery systems.

Your responsibilities include:

• Lead formulation feasibility and early development for implantable or device‑integrated combination products
• Establish formulation strategies addressing stability, materials compatibility, usability, and manufacturability
• Define Critical Quality Attributes (CQAs) linked to activity, potency, aggregation, and degradation pathways of the active component
• Evaluate interactions between the active component and biomaterials, including adsorption, encapsulation, binding, and release behaviour
• Assess the impact of sterilization on formulation stability and integrity

You will also lead the execution of feasibility, performance, and safety studies.

• Manage a team of scientists and technicians
• Coordinate studies conducted internally and with external partners
• Collaborate closely with the Design & Development and Product Development teams to ensure formulation candidates meet user, quality, regulatory, and manufacturability requirements

2. Safety & Biocompatibility Leadership

In this role you will own the safety strategy for the biologically active component within the implantable system.

Key responsibilities include:

• Define and drive the safety strategy for the active component and its interaction with the device
• Perform formulation‑specific risk assessments
• Collaborate with (pre)clinical and toxicology experts to design and interpret in vivo safety and bioactivity studies
• Guide the development of analytical methods used to assess safety‑related attributes

You will ensure that safety considerations are fully integrated into:

• Design control processes
• Risk management activities
• Regulatory documentation

3. Product Performance & Release Profile

You will define how the biologically active component performs within the final combination product.

This includes establishing performance criteria and leading studies that demonstrate the intended biological effect.

Your work will include:

• Defining product performance criteria for the active component
• Leading in vitro testing, in vivo performance studies, and stability studies
• Collaborating with the Clinical team to support the development of the clinical strategy
• Evaluating alternative delivery concepts to optimize release kinetics and biological performance

4. Cross‑Functional Technical Integration

Success in this role requires strong collaboration across disciplines.

You will work closely with Development, Quality, Regulatory, and Clinical teams to ensure formulation, safety, and performance considerations are integrated throughout feasibility.

Key activities include:

• Driving cross‑functional collaboration across technical teams
• Leading joint experiments supporting feasibility and GMP manufacturability
• Ensuring feasibility outputs are traceable, risk‑based, and ready for transfer to the Product Development team

5. Regulatory & Quality Responsibilities

You will play an important role in shaping the early regulatory and development strategy for combination products.

Together with Design & Development, Clinical, and Regulatory Affairs, you will support early interactions with the FDA and other regulatory bodies.

Your responsibilities include contributing to:

• Pre‑submission packages
• Briefing books
• Early CMC roadmaps
• Risk management documentation

You will ensure compliance with relevant regulatory frameworks, including:

• 21 CFR 210/211 for biologics
• 21 CFR 4 for combination products
• Directive 2001/83/EC and Regulation 726/2004/EC (Medicinal Products)
• ISO 13485 Quality Management Systems
• ISO 14971 risk management
• ISO 10993 biocompatibility standards

Additionally, you will support preliminary regulatory designations and early scientific guidance discussions.

6. Leadership, Partnerships & Program Management

As Director of Biologics, you will lead the biologics function within the feasibility program and ensure alignment with broader development objectives.

Your leadership responsibilities include:

• Leading and developing a team of scientists and technicians
• Managing external partners supporting formulation and analytical development
• Building feasibility plans, budgets, timelines, and decision gates tied to safety and performance attributes
• Presenting feasibility results and risk‑mitigation strategies to executive leadership and governance bodies

Qualifications Required

• PhD in (Medical) Biology, Biochemistry, Pharmaceutical Sciences, or a related field
• 5+ years of experience in biologics formulation or drug delivery development
• Experience with combination products or implantable systems

Demonstrated expertise in:

• Formulation, stability, and degradation pathways
• Sterilization impact on biologics
• ISO 10993 biocompatibility
• Extractables and leachables
• In vitro and in vivo release characterization

You also bring:

• Strong cross‑functional leadership experience in early‑stage development environments

Preferred experience

• Experience with sustained‑release formulations
• Knowledge of biomaterials such as ceramics, synthetic and natural polymers, and bone grafts
• Experience supporting regulatory submissions or scientific advice interactions
• Experience with performance testing of implantable combination devices

Why Kuros Biosciences?

Join an international, innovative company with a diverse and energetic team. At Kuros, you’ll work in a positive and collaborative environment, contributing to the development of life‑changing products. We offer great benefits, a competitive salary, and opportunities for career growth.

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