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Bioassay Project Lead
vor 3 Monaten
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The PositionPharma Technical Development Europe Biologics brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, analytics, formulation, device and packaging. Our daily work includes authoring of regulatory documents and the transfer of development projects to the commercial organization.
We are striving for a caring and sensing network organization, which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise, passion and "getting it done" mentality. The benefit for the patient is in the center of our thoughts and efforts.
The bioassay groups as part of the department Analytical Development and Quality Control Biotech Europe are responsible for Analytical Development, Quality Control and Compliance for Biopharmaceuticals from pre Investigational New Drug (IND) to Biological Licence Application (BLA) and Launch.
Your contribution- Evaluation, implementation, and further development of new technologies/ test methods to ensure the biological activity of our Biopharmaceuticals
- Quality control for investigational medicinal products and batches used in preclinical and clinical studies
- Preparation and support of IND and BLA filings
- Creation and securing an efficient GxP conform environment in accordance with the current GxP guidelines and relevant SOPs
- Matrix leadership responsibility for a project team of approx. 4-8 lab associates
- Establish close and trustful collaborations and relationships
You are someone who wants to influence your own development. You are looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. Additionally to that, we are looking for the following qualifications and experience:
- PhD in life science as Biology, Biochemistry, Pharmacy or similar scientific qualification with several yrs of experience in biopharmaceutical industry with focus on cell based assays. Experience in a GMP environment is a must.
- Experience in development of new technologies -in particular surface plasmon resonance- and methods for biological analysis and characterization of proteins
- Excellent leadership skills and proven track record in people management and collaboration
- Excellent verbal and written communication skills with success in building trustful relationships
- Self-motivated, proactive, responsible, result-oriented and an excellent team player
- Good communication and negotiation skills in English, German is a plus
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
