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Research Specialist - Bioanalytical

Job Summary:
A Research Specialist – Bioanalytical Chemistry is responsible for: validating and following established methods to quantify chemical entities according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. The individual in this role demonstrates proficiency in the use of instrumentation and laboratory techniques; effectively applies his/he experience and knowledge to conduct method validations and troubleshoot method issues. This individual contributes to the department by working independently, completing assigned projects on time, participating in process improvement initiatives, and communicating effectively with others.

Essential Functions (The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed: 
  • Isolates and quantifies compounds for routine sample analysis utilizing standard analytical and bioanalytical platforms.
  • Validates new methods for production environment.
  • Documents procedures and materials in compliance with GxP standards.
  • Operates applicable laboratory instruments, including their respective software applications, to prepare samples and quantitate sample runs.
  • Assists in the completion of laboratory investigations, assay troubleshooting, and quality observations, as needed.
  • Recognizes method and data issues and communicates them to management to minimize study impact.
  • Contributes expertise to process improvement initiatives.
  • Assists in training new staff members as applicable.
  • Performs additional work as assigned.
Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
  • HS/GED and 12 or more years of relevant experience or Associate’s degree and 6 or more years of relative experience or Bachelor’s/Master’s degree and 2 or more years of relevant experience; contract research organization experience preferred.
  • An equivalent combination of education and experience may be accepted as satisfactory substitute for the specific education and experience listed above. 
  • Demonstrated proficiency using laboratory software application, including laboratory information management systems (LIMS) and data acquisition software. 
  • Ability to communicate verbally and in writing at all levels inside and outside the organization.
  • Basic familiarity with Microsoft Office Suite.
  • Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
  • Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
  • Ability to work under specific time constraints.