· 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
· 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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