Bioanalytical Scientist

**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 set-up the fit-for-purpose methods, ensure compliance to applicable guidelines and appropriate documentation before study starts
- Closely follow-up 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. 2.7.1 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 non-clinical 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 problem-solving 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