Summary: The Associate Scientist – Analytical Method Transfer (AMT) will function collaboratively and productively in a team devoted to ensuring the quality of effective analytical methods at FDBT. The individual should possess experience with several bioanalytical techniques that are used to assess viruses and proteins as well as strong technical writing skills.
The AMT group is a protocol-driven group which will primarily perform Tech Transfer, Qualification, and Validation of test methods coming out of the FDB analytical groups and transition them into our Quality Control group. The position will primarily focus on executing analytical method protocols, summarizing data, coordinating instrumentation needs, finalizing test methods and ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success. The candidate will be expected to follow cGMP documentation practices.
The ideal candidate will have knowledge and expertise relevant to viral and protein analytics and protocol-based method evaluations.
This position will not have direct reports.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: