Bioanalytical Scientist

Vor 7 Tagen

Basel, Schweiz Sobi Vollzeit

**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.**

**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 Basel, Switzerland.

**Reporting to**
Head of Preclinical Development and Translational Medicine

**Recruitment contact & how to apply**

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

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