The QC Associate-Method Validation will participate in the assay performance, qualification/validation of assays and laboratory equipment, and transfer of standard protein characterization methods. Duties will be carried out in accordance with quality standards and procedures set by the company and applicable government agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Participate in qualification/validation of analytical methods.
Assist in preparation of method qualification/ validation protocols, reports and test method SOPs.
Author / execute method transfer protocols for various analytical methods for the characterization of biopharmaceutical protein products.
Work on developing and improving assays for various projects as needed.
Work under general supervision of QC scientist / manager to meet project goals in a timely manner.
Specify and source new analytical equipment as required to expand the testing capabilities of the QC Analytical Laboratory.
Assist with the overall maintenance and calibration of the QC laboratory analytical equipment as needed.
Analyze laboratory data for trending.
Support the training of new and existing laboratory personnel
Evaluates technology transfers associated with new products or processes.
Other duties as assigned.
B.S. in Life Sciences/Chemistry
2+ years of industry experience is expected. However, successful academic research experience will also be considered.
Working experience with a range of protein analytical/bioanalytical techniques including ELISA, HPLC, UPLC, enzymatic, and electrophoretic (SDS-PAGE, Western blots, IEF and CE) procedures.
Experience in a GMP Laboratory / environment is plus.
Organizational, multitasking, problem-solving, math, statistical, interpersonal, written and oral communication skills. Detail-oriented and ability to prioritize work.
Must be able to work within multifunctional teams.
Ability to function well in a fast-paced multiple project environment.
Communicates openly with development, production & quality personnel to resolve problems before or as they arise.
While performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.
While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate.