Excellent Associate Scientist role with a global biotech based in Cork
Excellent role in with an American Biotechnology company based in Cork. This is an Associate Scientist role working as part of the Analytical Operations team. This role is also open to those who have completed a PhD with no post-doctoral assignment, and those who have 9+ years industry experience. If you are interested, please apply below.
- Applies advanced level of understanding of analytical methods.
- Selects appropriate methods and techniques in performing methods development.
- Independently plans and executes experiments that support routine & non-routine development activities and project goals.
- Collaborates within & contract test labs to develop & validate methods.
- May design new experiments to support development of drug substances and drug products or techniques to test such substances.
- May create API or drug product specifications.
- Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
- Collation of data and technical writing for submissions for regulatory filings.
- Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
- Operates as part of a global sub team as an AO lead
- Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Works independently and determines methods and techniques on new or difficult assignments.
- Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
- Acts as a resource for other employees within the department.
- Task management of junior employees may be required
- Manage group with multiple areas of responsibility and may lead a component of a project within the job family.
- Identifies and introduces new technology and/or methods to the organization and trains junior staff.
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.
- Has scientific expertise and ability to think ahead to the next step in drug development process.
- Working knowledge of GMPs, pharmacopoeial, regulatory requirements for analytical testing, phase appropriate standards for method validation.
- Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
- Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.
Typical Education & Experience
- 11+ years of experience with BA or BS degree in Chemistry or Biology.
- 9+ years of experience with MS degree in Chemistry or Biology.
- PhD with no post-doctoral assignment.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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