Head of R&D Hillerød
About the client
SSI Diagnostica provides innovative products for disease surveillance, diagnosis, outbreak investigation, and quality control in three specialized segments: gastric, respiratory, and bloodborne diseases, including rapid diagnostic tests, QC testing for vaccine products, antisera, and several other in vitro diagnostic products. The company serves a multitude of laboratories, clinics, and pharmaceutical manufacturers around the globe.
Until 2016, SSI Diagnostica was part of Statens Serum Institut, which was founded in 1902 and is renowned globally for its very solid foundation in research and proud traditions. In 2016, SSI Diagnostica was bought by Adelis Equity – a change of ownership, which has led to value creating acquisitions and increased investment in and focus on R&D activities, the commercial department as well as the manufacturing facilities and equipment. Today, the company is headquartered in Hillerød, Denmark, has two sites in USA and one in China and the company employ over 660 employees globally.
SSI Diagnostica’s overall mission is to improve l diagnostics for the benefit of both patients and society as a whole. They do that by supplying better and quicker diagnostics, working closely with their many customers, focusing on providing high-quality products based in their long history and expertise.
SSI Diagnostica is ISO 13485 certified and has taken out several patents based on the products developed by their R&D department.
About the role
Currently, SSI Diagnostica is seeking a skilled and dedicated professional, who possess experience in R&D within diagnostics development. The ideal candidate must have a proven track record of managing business complexity, technical ability, exhibit a high level of independence, innovation, and initiatives. Furthermore, the person should be business and customer oriented, have a value-adding approach, and the ability to work both independently and in cross-functional groups. Understanding patients’ needs and being able to develop solutions and products to tackle those challenges is key for the company. Strong commitment to delivering high-quality work is also considered an essential attribute for this role.
The Head of R&D Hillerød will become part of the global R&D team consisting of about 65 team members globally, of which 11 team members are located at the HQ in Hillerød.
Role Title: Head of R&D Hillerød
Reporting To: Head of Global R&D
Location: Hillerød, Denmark
- Product development of in vitro diagnostics products launched on schedule and to agreed technical quality
- Compliance with IVDR (EU-regulation 2017/746), US FDA and ISO standards (ISO 13485)
- Clear, visible and transparent leadership of the Hillerød team that ensures intensity, job satisfaction and engagement
- Support knowledge sharing and collaboration in the R&D team and across R&D teams in SSI Diagnostica Group
- Continuously developing the R&D team (both professional and collaborative)
- Continues the developing of the R&D team towards a high-performing team
- Ensures the development of the team members professional and personal competencies and qualifications
- Ensures the correct team composition to be able to execute accordingly to agreed plan. This includes e.g.:
- Organizational planning, assessment of team dynamics, organizational review, hiring/dismissals
- Promotes collaboration across geographies and functional areas
- Provides communication of SSI Diagnostica Group’s vision and strategy, translating it into scope and priorities for R&D
- Engages in a proactive dialog regarding future competence and development needs
- Provides impact throughout the products journey, from optimisation through to translation into a regulatory cleared and scalable product
- Ensures clear prioritization of tasks to achieve delivery as agreed
- Manages personnel administration, including planning, follow-up and registration of absence/holiday/leave etc.
- Ensures product development projects are completed on time and in the right technical quality
- Understands, sets boundaries and provides sparring regarding the product development process
- Understands, and provides sparring in relation to Assay development
- Report regularly (and in a timely manner) on the sum of technical R&D matters
- Ensure and maintain compliance with all quality requirements
- Responsible for R&D Hillerød Design Control System (Product Lifecycle Management)
- Provides profound understanding of diagnostic products – and can ask the right questions
Competencies – relevant experience and personal skills:
- Ability to work in a team-orientated, highly collaborative environment
- Ability to build effective relationships with internal and external stakeholders
- Genuinely cares about the people on their team, while setting a high bar for performance
- Embraces curiosity and has a problem-solving mindset
- Adopts a commercial mindset when evaluating concepts and progress throughout the product lifecycle
- Ability to organize own work with minimal supervision and prioritize own work in response to deadlines
- Diligent and proactive – Ability to identify and report potential problems accurately and early, and to find creative solutions to these problems with a hands-on approach
- Enthusiastic about progress in the diagnostics industry
- Flexible attitude towards work and ability to work in a fast-paced environment
- Discipline and regard for confidentiality, security, health and legal compliance at all times
- Enjoys a challenge, driving positive disruption in the industry
Qualifications – educational background and personal qualifications:
- An educational background in Biology, Chemistry (or related) with proven scientific and laboratory experience
- Experience in product development of diagnostic solutions
- Experience in immunoassay design and development is preferred
- Experienced user of IT with flair for new systems
- Languages – fluent in English (written and verbal)
- Experience and knowledge of transfer to manufacturing
- Experience with relevant regulatory standards, such as IVDR
- Experience with CA/CE marking process, as well as CLIA and FDA pathways
- Experience of managing a product through from concept to optimization and validation
To apply for this role, simply click on the Apply Now button on top, or send your CV to firstname.lastname@example.org
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