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Senior Associate Scientist

Quality & Laboratory
Cork
Siobhán Lane
Permanent
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Job Reference: JO-2006-65233_1591961375

Summary:

Responsibilities:


· 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 with teams on site & 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



Requirements:


· 11+ years of experience with BS degree in Chemistry or Biology.


· 9+ years of experience with MS degree in Chemistry or Biology.


· PhD with no post-doctoral assignment.


· 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.


· Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.



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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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