For a internationally renowned pharmaceutical client in Geleen we are looking for a Senior Biochemistry Specialist. In this company you will the Subject Matter Expert (SME) concerning all biochemistry instruments
As a Senior Biochemistry Specialist you work within the Quality Control department, and ensure that all existing GMP and safety standards are met. Within the QC department you will act as a contact person for complex problem handling and complex activities that require knowledge and skills in the relevant expertise sector. As a Senior Biochemistry Specialist you will applied your scientific skills, current regulatory guidance and GMP knowledge and experience to provide advice and suggest improvements where necessary. You act as a representative of the QC department for Analytical Method Validation topics in close collaboration with Analytical Development (R&D) at team meetings, Quality Councils, client meetings as appropriate.
The position must thoroughly understand the method validation and implementation activities related to the applicable expertise, gap analysis, method readiness and other QC related issues in his/her industry.
Participates in the initial assessment of new methods to be transferred to Quality Control
SME for method specific devices
Responsible for method validation plan including protocol, data review, statistical analysis, report preparation and review.
Will also lead and participate platform method validation strategy implementation and assessment for future projects.
The technical expert is expected to provide input for problem-solving of issues within his/ hers branch
Education: Masters or higher in Biochemistry, Biotechnology, Life Sciences, Pharmaceutical Chemistry.
Experience: Preferred 10 + Years in Biologics QC/Analytical Development (minimal 5 years)
Background: Hands on experience on Analytical method Validation of physico-chemical methods
Desirable: Knowledge about ICH guidelines and other regulatory agencies. Global Audit experience.
Good knowledge and experience of analytical methods, equipment and good practices for Biological Products.
Good understanding of QC analysis e.g. HPLC, Capillary Electrophoresis, RTPCR, UV Spectrophotometer, Gas chromatography, ELISA, safety tests
Directly employed by the client
Salary indication: €3200-€5200 per month
Full time on site
Vacancy number: 22837