Python Job: Group Head Analytical Development and Quality Cont

Please note: temporary contract (3 years )

Pharma Technical Development Biologics Europe 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 biotech 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 Position

The department 'Analytical Development and Quality Control' is responsible for analytical method development, validation and quality control testing for biopharmaceuticals from pre-IND stage (Investigational New Drug application) to BLA (Biologics License Application) and launch.

The Group & Project Lead is responsible for:

• Direct leadership responsibility for a lab team of approx. 4-6 members performing analytical method development, method validation and quality control testing for biopharmaceuticals
• Representation of Analytical Development and Quality Control in global technical development teams including the coordination of all necessary analytical activities
• Coordinate & oversee GMP quality control testing for biopharmaceutical investigational medicinal products and batches used in preclinical and clinical studies
• Setting of specifications and shelf life for investigational medicinal products and support of IND and BLA filings
• Evaluation, implementation, and further development of new technologies & test methods to ensure state of the art analytics, including publication in peer-reviewed journals and on conferences
• Creation of prerequisites for securing a competent, efficient GxP conform analytics in due time and keeping the current GxP guidelines as well as the relevant SOPs
• Establish close and trustful collaborations and relationships across cooperating functions within Pharma Technical Development Biologics Europe

Who you are

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 Analytics, Biochemistry, Pharmacy, or similar scientific qualification
• 3-5 years of experience in biopharmaceutical industry with focus on protein analytics (i.e. HPLC, CE) and characterization (glycosylation analytics and mass-spectrometry experience appreciated), preferably in a GMP environment, and/or pharmaceutical development of biotherapeutics
• Experience in development of new technologies and methods for biophysical/biochemical 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, pro-active, responsible, result-oriented and an excellent team player
• Excellent communication and negotiation skills in German and English
• Statistics expertise, experience with statistical models and their assessment and application is preferred
• Programming skills in a programming language are a plus (e.g. R, MatLab, Python)

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.