Scientist Regulated Bioanalysis

vor 2 Monaten

Basel, Schweiz Roche Vollzeit

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 Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

In Roche´s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

pRED's Pharmaceutical Sciences (PS) group enables discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation, continuously improve the accuracy of our predictions and accelerate the development of tomorrow's medicines. PS supports discovery and development across the whole value chain from target assessment to on-market and beyond.

This position is located in the Regulatory Bioanalysis and Biosample Operations chapter within PS, which is accountable for developing efficient end-to-end (E2E) patient-centric biosample strategies ensuring maximum utilization of every sample comprising PK, immunogenicity, safety and PD (soluble target and biomarkers) endpoints and ensures assay readiness, data context enabling decision making and ultimately deliver robust and fit for purpose regulatory filings.

The Opportunity

This position is an excellent opportunity for a talented Scientist to integrate into a dynamic lab team dedicated to the support of pre-clinical and clinical projects when complex bioanalytical assays or time-critical data are required. As part of the pRED organization you continuously participate in improving processes.

  1. You have full accountability as Validation Study Director for the validation of bioanalytical assays to quantify novel therapeutic proteins / soluble targets/biomarkers or to detect anti-drug antibodies fulfilling project requirements and international guidances.
  2. You support the bioanalytical phases of GLP Tox studies and clinical phase I/II/III studies as Principal Investigator / Responsible Scientist through timely delivery of high-quality bioanalytical data.
  3. You provide validation reports and bioanalytical reports in a timely manner using document templates.
  4. You promote an efficient, state-of-the-art and GLP/GCP-compliant laboratory by continuous process improvement and inform the laboratory head of any technical and/or analytical needs.
  5. You participate in laboratory audits and inspections.
  6. You maintain trustful relationships and effective collaboration with internal stakeholders (e.g. Lab Specialists, Bioanalytical Managers, assay development laboratories) and external partners (e.g. Contract Research Organizations).
Who you are
  1. You have an M.Sc. degree or equivalent education in Biology, Biochemistry, Pharmaceutical Sciences and over 3 years of experience with quantitative ligand binding assays (e.g. ELISA) as a responsible scientist in a regulated environment.
  2. You are authoring pertinent study documentation in a timely manner (e.g. bioanalytical plans and reports) and are proficient in the use of laboratory information management systems (e.g. Watson LIMS).
  3. You are experienced with assay troubleshooting and lab process improvement (e.g. lab automation).
  4. You have a good command of English, both written and spoken. Knowledge of German is a plus.
  5. You are dedicated to establishing a culture of mutual support, cross-training, continuous learning and self-organization to meet project and functional goals. You are resourceful and flexible in problem-solving and in working in a collaborative and inclusive manner. You can identify your top deliverables and finalize projects to achieve results whilst assuming personal responsibility for outcomes.

Unwavering focus, collaborative teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together, we can be transformative.

If you are passionate about contributing to a committed team and have the dedication to partnership and innovation, Roche is the place for you Every role at Roche plays a part in making a difference in patients’ lives. Apply now and join us in making an impact

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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