Bioanalytical Scientist

vor 1 Woche

Basel, Basel-Stadt, Schweiz Sobi Vollzeit

Role & Function

Key Responsibilities

  • Responsible for development and validation of bioanalytical assays with outsourcing partners (CROs) in the areas of pharmacodynamic, immunogenicity and biomarkers for measurement of human clinical samples
  • Participate in CROs selection and give input to the Clinical Study team
  • Liaise with CROs to setup the fitforpurpose methods, ensure compliance to applicable guidelines and appropriate documentation before study starts
  • Closely followup the CROs to ensure delivery of critical bioanalytical data in a timely manner and proper reporting
  • Ensure method troubleshooting if required
  • Perform raw data monitoring by random check of runs to ensure that data quality is fit for the intended purpose, and document appropriately
  • Responsible for the quality and the timely filing of the final bioanalytical regulated documents in the designated repository
  • Liaise with internal and external stakeholders to set and refine the strategy for bioanalytical endpoints and better define the context of use
  • Acting as Bioanalytical SME within the Clinical Study Teams and the regulatory submission Teams for assigned projects
  • Provide updates within the Clinical Study Team on timelines and identified bottlenecks
  • Participate in the review of key clinical SOPs, laboratory manuals, clinical protocols, clinical study reports, CROs contracts
  • Writing and revision of bioanalytical sections of regulatory documents in support of Global filings Worldwide (e.g module)
  • Acting as SME for questions on submission dossiers, Q&A and inspections from regulatory authorities for Bioanalytical Sciences function
  • Interacts where required with external consultants or experts in the Bioanalytical field
  • Ensure alignment within the PDTM department and within the project teams on budget, timelines and accruals

Qualifications

  • Ideally a PhD in Biology, Immunology or Bioanalytical Sciences with minimum 5 years of relevant experience as Bioanalytical Subject Matter Expert
  • Knowledge of regulations and guidance relevant to GCP and GCLP, as applicable to laboratories, and nonclinical sample testing
  • Ability to represent the bioanalytical group in project teams, drive the scientific discussion and rationale for all bioanalytical endpoints
  • Ability to influence teams to ensure bioanalytical data generated is of the highest quality
  • Ability to communicate with a wide range of internal stakeholders including Research Scientists, Non-Clinical Safety, Clinical Pharmacologists, Clinical Scientists, Clinical Operations, IT and Quality Assurance colleagues
  • Knowledge of a range of bioanalytical techniques including immunoassay to support the analysis of pharmacokinetic, biomarker and immunogenicity endpoints
  • Experience in LC-MS/MS methods is a plus
  • An understanding of pathology and therapies underlying immunological and oncology diseases
  • Experience in managing CROs to ensure the appropriate level of scientific and technical content is provided to support of clinical development

Personal attributes

  • Well organized, structured approach to work with demonstrated ability to focus on details
  • Capable of communicating complex scientific information clearly and concisely
  • Advanced level in spoken English, with the ability to clearly articulate technical/scientific issues
  • Demonstrated interpersonal skills including teamwork, negotiation, problem solving and decision making
  • Advanced level in written English with ability to write and review scientific/technical reports, review QA documents and prepare poster and Powerpoint presentations
  • Critical thinking and problemsolving skills
  • In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

Location
The position will be based in Switzerland.

Reporting to
Head of Preclinical Development and Translational Medicine

Why Join Us?


We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate.

With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity.

Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here.

If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by

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