Industrialization Manager

For Biocartis as an organization, it is important to have the people in place who can make the company’s strategy happen. The Industrialization Manager plays a pivotal role in orchestrating this.

The key mission of the Industrialization Manager II is

• to develop a ’functional powerhouse’ with highly capable resources, and
• to operate as the process owner of efficient and effective business processes.

The Industrialization Manager II also provides expert input to programs and coaching to the employees and teams.

The Industrialization Manager’s primary role is talent, competence and resource management. He/she is an expert in his/her respective discipline.

In this way, the Industrialization Manager II will make sure that his/her function performs at the best of its ability by having talented and trained resources and effective and efficient processes in place.

Accountabilities

The role includes, but is not limited to, the following accountabilities:

• Accountability for leadership of the industrialization team incl. amongst other establishing a resource and competence plan in line with the company strategy, product roadmap, company objectives and budget;
• Managing, overseeing and balancing resource allocation; makes sure that the projects are equipped with strong people;
• Leading all operational aspects of the function while continuously striving for performance improvement and effectiveness;
• Liaising with project and functional leads to deliver competence and capacity according to business demand and budget;
• Operate as the process owner of efficient and effective business processes of the industrialization team:
  • The Industrialization Manager oversees overall cartridge manufacturing process development activities in support of assay development projects, and ensures establishment of related design and development processes in line with IVD regulations
  • The Industrialization Manager oversees overall QC method development and validation activities in support of assay development projects, and ensures establishment of related design and development processes in line with IVD regulations
  • The Industrialization Manager manages the stability strategy in view of shelf-life determination/extension of raw materials, intermediate and finished products and ensures establishment of related design and development processes in line with IVD regulations
  • He/she acts as a leader for and advises in view of manufacturability and/or QC issue resolution for on-market products
• Accountability for financial monitoring of the industrialization team in collaboration with the Departmental budget holder;
• Cascading company objectives within the industrialization team;
• Reporting and/or escalating to the appropriate governance body;
• Providing expert input into programs and acting as independent technical reviewer;
• Leading the industrialization team ensuring continuous growth and development of team members via coaching, on-the-job learning and training.

Profile requirements

• Master degree in Science- or technology-related study domains or equivalent through experience
• Minimum 5 years of work experience in an industrial setting, of which 3 years in a people management role
• Well-developed people management skills, including experience with (senior) scientific profiles
• Knowledge of the technologies and chemistries that are applied in the molecular diagnostic market, including qPCR and/or NGS technologies
• Experience with manufacturing process and QC development activities in a GMP environment
• Planning and organization:
  • Team and project planning; stakeholder management – plans ahead, monitors results and adapts plans
  • Manages the allocation of resources/allocated resources in relation to business needs and budget.
• Steering:
  • Sets direction to the team: is able to motivate, guide and direct staff members in reaching their business goals;
  • Monitors and/or evaluates performance, provides balanced feedback and ensures support to develop the required competencies
• Resilience:
  • Maintains self-control, direction and effectiveness in high pressure situations.
  • Maintains team’s effectiveness, quality and morale during difficult times
• Support and facilitates change – enables and shapes change, helps others to understand the need for change and adapt to it
• Strategic Thinking – translates Biocartis vision and strategy into SMART plans for the team and programs.
• Coaching & development - Provides ongoing feedback, creates development opportunities and plans to meet employees’ needs and aspirations
• Legislation and regulation:
  • IVD Directive and new IVDR
  • 820CFR
  • ISO13485
  • ISO14971
  • ICH
  • USP/EP
• PC skills: applied knowledge of MS Office (Excel, PowerPoint, Word, Outlook)
• Languages: fluent in English and Dutch, both written and spoken.

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.