At Vivalyx, a medical technology startup based in Aachen, we're on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to significantly improve the vitality and availability of donor organs. As we are scaling, we're seeking a Head of Production – Omnisol (m/f/d) to join us starting as soon as possible, for 32-40 hours per week.

We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.

The Head of Production – Omnisol will build and lead the production and operational setup required to ensure sufficient and reliable supply of Omnisol for patients and physicians across Europe. This role will own the development of the production model, including process design, supplier setup, production scale-up, facility build-up, validation, and operational readiness to support growing demand across the European market.

The role has a strong operations focus and requires a highly credible, hands-on senior professional who can combine strategic judgment with pragmatic execution. While quality assurance is not the core focus of the position, it is an important part of the role and must be addressed as an integrated component of production and operational decision-making.

The position sits within a regulated European medtech environment and requires close collaboration with regulatory and quality functions to ensure that production-related activities are established and maintained in line with applicable ISO standards, the European Pharmacopoeia, and the requirements of the EU Medical Device Regulation (MDR; Regulation (EU) 2017/745).

Tasks

The Head of Production – Omnisol will establish the production and operational foundation needed to supply the European market reliably and at scale. The role is responsible for ensuring that the right production capacities, processes, partner structures, and operational controls are in place so that sufficient Omnisol is available to meet the needs of patients and physicians across Europe.

This includes shaping the production setup, supporting supplier and manufacturing structures, driving validation and production readiness, and helping build an operating model that can meet the requirements of the European regulated environment**. The role requires comfort moving between strategic production decisions, cross-functional coordination, and hands-on resolution of operational issues.**

Core Responsibilities

1. Production Scale-Up and Operational Readiness

• Ensure that production structures are designed to provide sufficient Omnisol availability for demand across Europe.
• Lead the further scale-up of Omnisol production toward a more robust operating model for the European market.
• Shape the production strategy and support key decisions regarding production setup, supplier structure, and capacity development.
• Re-design and implement production-related processes required for reliable, efficient, and scalable supply across Europe.
• Steer and support investments related to production capabilities, infrastructure, and facility build-up.
• Oversee and coordinate validation activities required for production implementation and scale-up.
• Work closely with internal stakeholders to ensure that production processes and operational decisions support the requirements of the European medtech market.

1. Operations and Supply Reliability

• Take ownership of the operational setup required to ensure continuity of supply and dependable product availability across Europe.
• Monitor and improve production-related operational flows, including interfaces with suppliers, manufacturing partners, and logistics processes.
• Act as the key operational counterpart when issues arise that could affect product availability, delivery reliability, or process performance.
• Resolve operational issues with speed and ownership while identifying root causes and implementing sustainable improvements.
• Build and optimize processes that support reliable execution, scalability, and operational resilience.
• Contribute to the development of a dependable production and supply backbone for Omnisol in Europe.

1. Quality and Compliance Responsibilities

• Take responsibility for production-related quality topics as part of the broader production leadership role.
• Ensure that quality requirements are appropriately embedded in production, validation, and operational processes.
• Work closely with the quality and regulatory teams to ensure alignment with applicable ISO standards, the European Pharmacopoeia, and relevant requirements under the EU Medical Device Regulation (MDR).
• Monitor quality-critical operational topics and ensure timely escalation, resolution, and follow-up where needed.
• Support the establishment of a production environment in which quality and compliance are integrated into execution, process design, and operational decision-making.
• Ensure that external manufacturing and supply-related processes are supported by an appropriate level of quality oversight and documentation.

1. External Partner and Relationship Management

• Build strong working relationships with suppliers, manufacturing partners, and other relevant external stakeholders.
• Establish credibility quickly through sound judgment, professional presence, and practical problem-solving capability.
• Work closely with external partners and represent Vivalyx confidently in production-related discussions.
• Support the development of effective collaboration models with contract manufacturers and supply partners.
• Contribute substantial face time and relationship continuity with external partners from the outset, with scope to take on broader ownership of such relationships over time.

Requirements

The ideal candidate brings substantial experience in production, operations, and scale-up within a regulated environment and is comfortable taking responsibility in a setting where structures are still being built. The role requires a strong combination of strategic thinking, implementation discipline, and sound judgment.

This position would suit someone who is able to translate complex requirements into robust processes, navigate ambiguity without losing momentum, and work effectively across technical, operational, regulatory, and external stakeholder interfaces. A background that combines STEM or laboratory exposure with experience in structured problem-solving environments, including consulting, could be highly relevant if paired with sufficient operational credibility and implementation strength.

Required Qualifications

• Passion for working in medical technology development
• Strong sense of ownership, reliability, and attention to detail
• Confidence in identifying issues early, speaking up when needed, and driving decisions in a constructive and solution-oriented manner.
• Fluent in English, both written and spoken (German is a strong plus)
• Degree in engineering, life sciences, chemistry, bioprocessing, operations, or another relevant technical or scientific discipline.
• Significant professional experience in production, manufacturing, operations, or process scale-up in a regulated environment.
• Experience working within or alongside quality and regulatory requirements relevant to the European medtech, healthcare, or life sciences market.
• Proven experience building or scaling production-related processes and infrastructure.
• Experience working with external suppliers, manufacturers, or other critical operational partners.
• Ability to work on-site at least twice a week in our production facility next to Berlin

Preferred Qualifications

• Experience in start-up or high-growth environments.
• Experience in the European medtech, medical device, biotech, or broader regulated life sciences sector.
• Familiarity with the EU Medical Device Regulation (MDR; Regulation (EU) 2017/745) and its practical implications for production and operations.
• Familiarity with applicable ISO standards and the European Pharmacopoeia in a production-related context.
• Experience with validation, facility setup, and production investment planning.
• Experience working with CMOs or other outsourced manufacturing models.
• Experience building supply-relevant operational structures in an evolving organization.
• Previous experience in consulting may be valuable where combined with relevant technical training and clear evidence of hands-on implementation capability.

Benefits

We provide the opportunity to work on groundbreaking technology that has a meaningful impact. You'll be part of a dynamic, highly skilled, and motivated team. We prioritize flexibility, offering mobile working conditions and a flat hierarchical structure. In addition, we support professional development and career growth, along with an attractive employee participation program.