RESEARCH INVESTIGATOR I
Job Responsibilities:
1.Responsible for technical support for the inprocess, release, and stability
methods for bulk and or drug products. Perform troubleshooting to solve
analytical related problems during in process, release, and stability testing
to determine remedial steps to correctly resume testing, while guaranteeing
compliance. 2.Serve as a liaison between Quality Control and other support
groups, e.g. QA, Validation, and Analytical Research, to assure that current
laboratory method issues are being properly addressed. 3.Design, evaluate, and
execute Analytical Method Transfer protocols. Execute transfer and start up of
new and existing methods into the Quality Control ensuring that critical assay
parameters are clearly communicated to the receiving site. 4.Design, execute
and evaluate method development protocols to ascertain the required degree of
validation for new and existingmethods guaranteeing implementation of a
feasible, efficient, rugged, and robust method. Hands on development,
validation, and improvement of analytical methods as needed. 5.Support
technical aspects of test method ruggedness and robustness processes. Work with
the Analytical Ruggedness Project Manager and Quality Control to gather
information on investigations, troubleshooting, method deviations, method
optimization, and method change control. 6.Provide timely and
efficienttechnical support. Write comprehensive technical reports to document
all analytical improvement or investigation projects. 7.Coordinate projects to
assure succe ssful and timely execution, issuance and updating of detailed time
and event schedules. Manage special analytical projects as needed to accomplish
company goals and objectives. 8.Manage project time tables for new and ongoing
analytical projects. 9.Evaluate analytical method deviations with respect to
their causes andcorrective actions to prevent recurrence. 10.Evaluate and
appraise method and instrument changes in regards to regulatory requirements.
Job Requirements/Education:
PhD degree in Chemistry, or Master in chemistry with at least two years
experience in pharmaceutical industry in method development and method
transfer, or BS in chemistry, with eight years experience in pharmaceutical
industry with at least two years experience in method development and method
transfer.Experience in method improvement and troubleshooting. Literacy of
pharmaceutical industry analysis of Bulk Products and finish dosage forms.
Technical writing and oral communication skills, English Spanish. Project
management skills. Knowledge of Statistical Process Control, and Design of
Experiments with demonstrated analytical and problem solving Skills. Experience
with HPLC, HPLC MS, GC, GC MS, IC, NMR, XRay Diffraction, DSC, TGA, FTIR, FT
Raman. Available to work at diferent BMS sites.Main work location BMS Humacao.
Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D
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