Position: Mid-Senior level

Job type: Full-time

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Job content

The Position

Pharma 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 organisation.

We are striving for a caring and sensing network organisation, 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 centre of our thoughts and efforts.

The Position

The department ’Analytical Development and Quality Control Biotech Europe’ is responsible for Analytical Method Development, Quality Control and Compliance required for Analytics of Biopharmaceuticals from pre IND (= Investigational New Drug) application to BLA (Biologics License Application) and Launch.

The Head of Particle Laboratory is a Scientist/Senior Scientist position and is responsible for:
  • Leading a group dedicated to characterisation of sub-visible and visible particles in biopharmaceutical dosage forms during pharmaceutical development and drug product quality control/stability studies
  • Serving as particle expert for all development projects including the coordination of all necessary particle characterisation activities using cutting-edge technologies to ensure efficient project support
  • Support particle-related root-cause analyses and investigations
  • Facilitating visual inspection training and ensuring availability of compliant and up-to-date particle-testing/characterisation SOPs
  • Evaluation, implementation, and further development of new technologies for particle characterisation in biotechnological dosage forms including publication thereof

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.

In addition, 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 particle characterisation, protein analytics, and/or pharmaceutical development of biotherapeutics
  • Experience in development of new technologies and methods for particle characterisation in biotechnological dosage forms
  • 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 at least one programming language are a plus (e.g. R, MatLab, Python)

The next step is yours.

Who we are

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.
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Deadline: 05-05-2024

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