Description:
Global Pharmaceutical company based in Cork, Ireland - looking for Senior Analytical Scientist.
The successful candidate will be responsible for analytical operations in support of clinical programs, formulation development, quality control testing to support our GMP operations and includes a function which supports preparation of regulatory submissions.
The Job:
- Executes assigned experiments and lab tasks efficiently, consistently, with high quality and suggests improvements.
- Maintains familiarity with scientific literature, regulatory requirements and applies appropriately to research projects.
- Recommends alternatives, research new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems.
- Prepares and executes study protocols and reports.
- Selects appropriate methods and techniques, in collaboration with Supervisory personnel, to perform method development.
- Interprets and analyses data from experiments for both accuracy and impact.
- May create API or drug product specifications as well as test methods and study protocols / reports.
- Prepares reports based on analysis and interpretation of data.
- May have a specific area of specialization such as a study type or specific technology in lab.
Skills & Expertise:
- Develops skills in data analysis and ability to evaluate quality of data.
- Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects.
- Uses strong communication skills (both verbal and technical) and interpersonal skills to communicate objectives and results.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- Working knowledge of GMPs, pharmacopeial, regulatory requirements for analytical testing, phase appropriate standards for method validation.
- Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.