Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
3 Years
Description
- Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.
- Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.
- Draw up study plans and execute studies in strict accordance with study plan and SOPs ensuring full GMP regulatory compliance, where appropriate.
- Liaise with the Quality Department for the generation of audit responses, deviation reports and for the compilation of study reports.
- Responsible for leading laboratory investigations, where necessary.
- Responsible for reporting project progress information to Management.
- Provide technical training to scientific team, as required.
- Day to day liaison with clients regarding current and new projects.
- Involvement with regulatory and client audits.
- Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation requirement standards and guidelines.
- Generate new and update current standard operating procedures.
- Generate risk assessments for various projects as required.
Qualifications
Highest qualification: University
- Degree in relevant science discipline (e.g. Chemistry, Biochemistry Biotechnology, Immunology, Pharmaceutical Sciences, and Molecular Biology ), PhD is preferred but not mandatory.
- A minimum of 3 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Experience in study design, assay development, optimization, ICH analytical validation and project management.
- Experience in analytical techniques (e.g. HPLC (ELS, CAD, UV/Vis etc.), UPLC, ELISA, SDS-PAGE, CE-SDS, UV/Vis, GC, flame photometry, etc.) essential.
- Ability to project manage multiple studies.
- Knowledge and experience with statistical software.
- Ability to problem solve and work on own initiative.