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QA Project Manager CMC Development for APIs (f/m/d) 100%

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.  
Bachem. Leading Partner in Tides 

In order to continue our organic growth, we are constantly looking for talent.

Your responsibilities 

In the Quality Assurance department, we are looking for a well-organized and highly motivated Project Manager API (drug substance) development. In this newly created position you will be responsible to support innovative customer projects with regard to all quality related topics. This encompasses the definition of a control strategy and general project life cycle strategy from early GMP development, to process validation in the later phases until support of the commercial manufacturing phase. The QA Project Manager works to resolve GMP issues, that arise in close collaboration with colleagues from manufacturing, quality control, regulatory affairs and business development. You are therefore a core project team member, that interacts with multiple departments , actively coordinates project related work within our QA departments and communicates efficiently with international stakeholders. The responsibility of this function includes also the review and approval of GMP-relevant documents, decision making on GMP topics as well as review and approval of change control and deviation records in the electronic quality management system.

 

Your qualifications

You have a Master degree or Ph.D. in Chemistry or an equivalent qualification in natural sciences, and at least two years of experience in the chemical or pharmaceutical industry. You possess a very good GMP knowledge and ideally practical experience in drug substance development.  and project management. You work service-minded, task-oriented, structured, with good organizational skills and very good interpersonal skills. This includes proficient verbal and written communication skills in English and basic knowledge of German. Good command of German is a plus, as well as the willingness to learn.   As a strong team player you provide guidance on GMP related topics and support multiple, inter-divisional project teams in QA-related decisions. You achieve suitable solutions with internal stakeholders and customers,  using good negotiating skills and pragmatic approach.

 

We offer

We offer an exciting and challenging job in a dynamic and growing environment, which guarantees diversity and personal advancement. In this position, you have the opportunity to support the development of new drug substances until their market approval. You will be integral part of a team of experts and will be able to develop personally. In addition, we offer the opportunity to work in an innovative environment and a motivated team. The company grants attractive social security benefits, a modern and flexible home office option and an engaging corporate culture.    If this appeals to you, we look forward to receiving your application.

 

Are you interested? Please submit your application with full supporting documents. We only consider direct applications.