Planning, monitoring, and improvement of manufacturing processes and product approvals in cooperation with external manufacturers
Management of product documentation, packaging, and logistics for Proclarix®
Quality management, i.e., maintenance, documentation, and training on quality guidelines to meet our quality standards (e.g., EN ISO 13485) and to comply with legal requirements
Definition and monitoring of business processes and process performance
Responsibility for ordering and timely delivery of products to customers
Your profile
Degree in biochemistry or biotechnology with laboratory experience, preferably a doctorate
2 to 3 years of experience in the in vitro diagnostics industry and/or quality management
Excellent German and English skills for effective communication
Confident use of common and innovative IT applications
Entrepreneurial thinking, professionalism, pragmatism, discipline, and reliability
Your advantages
Part of a growing team in a biotech company with short decision-making processes and innovations that directly contribute to improving patient care
Rapid learning in the workplace and broad experience development within a short period of time
High level of responsibility and independence in the development of simple work processes
High flexibility in terms of working hours and the option to work remotely part of the time
Our customer
Proteomedix AG (an Onconetix company) is a commercial diagnostics company whose main product is Proclarix® for the early detection of prostate cancer. Proclarix® is CE certified in Europe in accordance with the In Vitro Diagnostic Medical Devices Regulation (IVDR) and is to be marketed in the US as a lab-developed test (LDT).
We are looking for a Head of Operations to join our team, who will play a crucial role in the quality and delivery of our product and the long-term success of the company. As part of the management team, you will report directly to the CEO and ensure the efficiency and quality of external manufacturing, product ordering and delivery, and all company processes in general, including quality management and regulatory compliance. You will define and monitor operational processes and workflows to meet productivity, quality, and risk standards. Location: Schlieren or Basel
