Currently, we experience a significant increase in demand. So, we plan to complement our CMC Project Management Team based in Basel, Switzerland with a
(Senior) Project Manager
ideally with extensive experience in late stage / commercial CMC regulatory affairs.
What you will do as Project Manager at Celonic…
As Project Manager you will be directly responsible and accountable for the commercial success of the company within allocated CMC development projects.
You will be responsible for planning and accurately executing projects in close collaboration with both your customers and internal Celonic departments (such as CLD, process and analytical development, QA/ QC and manufacturing and the management team). Celonic’s setting is very dynamic and entrepreneurial which will require your flexibility, experience and ability to fastly judge and react. You will be the single point of contact for your customers in all matters. You will have to communicate often, appropriately and precisely with those stakeholders, prepare presentations, reports and project controlling (budget and milestone tracking). Leadership of CMC project teams will be part of your daily job. In addition you will lead the project risk management (risk assessments (QbD) and implementation).
In addition, you will be the primary contact in the company for CMC regulatory questions and will contribute to regulatory submission dossiers (such as the CMC part for IMPDs) for different clinical trial applications of Celonic customers.
Who you are
You ideally have a PhD or advanced degree (like Master of Science) in a relevant scientific discipline (such as biochemistry, biotechnology, pharmaceutical sciences etc.). You have at least 10 years experience in managing biopharmaceutical development/ manufacturing and / or commercial projects. You accumulated extensive CMC – Regulatory Affairs experience of therapeutic biopharmaceuticals such as monoclonal antibodies (NBE / biosimilars). In particular you are familiar with regulatory requirements for late clinical stage biopharmaceutical Projects (clinical phase 3 and commercial application). We primarily look for regulatory experience with the European area, experience with the US regulatory environment is a plus.
You are an excellent communicator, fluent in English and ideally have a good command of German. You are a strong strategic thinker and able to devise implement workable solutions for complex situations. You are very empathetic and listen actively instead of making assumptions. You consider yourself a project team motivator and you are able to advocate your projects in front of your stakeholders. You can keep a strategic overview of your project portfolio and focus on constructive solutions with other parties. You have in depth knowledge of at least one of technical disciplines of biopharmaceutical manufacturing (USP, DSP, Analytics etc.).
Celonic is a dynamic and entrepreneurial company where you will be able to grow and develop. As a project manager you will have direct impact on the company’s results with a young and flexible team.
Our employees are important to us! We strive for a constructive and amiable climate. It’s expected that you contribute outside of your project to optimization of business processes, the general organisation, but rest assured that your initiative is needed and will be appreciated.
Are you interested applying for this challenging position at Celonic? If so, please send your application (preferably by email) to:
CH - 4051 Basel
Tel +41 (0) 61 5649-150