Research Assistant

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3 days ago Requisition

Salary: $62,354.00 Annually

SUMMARY OF POSITION

The Method Development and Analytical Services (MDAS) Research Assistant is a technical resource in performing the analytical testing necessary to support development and commercialization of new pharmaceutical products. The MDAS Research Assistant is responsible for performing the bench chemistry testing for release, stability and product characterization. The MDAS Research Assistant will work under the supervision of more experienced technical staff.

ORGANIZATION STRUCTURE

The Research Associate typically reports to a Group Supervisor/Leader, Manager or Director.

RESPONSIBILITIES

• Hands-on laboratory bench work and sample testing supporting development of pharmaceutical products. This includes but not limited to performing assay, related compounds testing, dissolution, uniformity, and other tests to characterize and demonstrate product performance.
• Perform laboratory bench work to develop, optimize, and troubleshoot analytical methods for testing raw materials and products (semi-finished and finished) under the guidance of senior staff.
• Assist in the execution of the laboratory work necessary for commercialization of pharmaceutical products. This includes laboratory work for method validation/verification/transfer, equipment acquisition/installation, reference standards qualification, drafting methods/reports, training, and other steps as required.
• Assist in drafting method validation/verification/transfer protocols and reports compliant with cGMP regulations, industry standards, and customer direction and consistent with the developed installation strategy and project scope.
• Conducts laboratory testing with high degree of accuracy and precision including but not limited to quantitative weighing and dilution, sample handling and processing, instrumental analysis using HPLC, GC, dissolution, UV-visible spectrophotometry, Karl Fischer, and other techniques as required.
• Complies with laboratory procedures and SOPs. Follows written and verbal direction from senior chemists to execute tasks and work independently with a minimum of supervision.
• Performs administrative functions, materials sourcing, vendor inquiries, exploration of new technologies as required to effect rapid and efficient project progression.
• Works efficiently, minimizing distractions and manages time to accomplish work by expected deadlines. Provides regular reports on progress to leadership and during team meetings.
• Work in compliance of all US and international regulatory agencies and compliance requirements as they relate to analytical testing.
• Maintains laboratory equipment and facility. Performs laboratory housekeeping duties as required.
• Travel as required to outside laboratories for the purpose of receiving training from a qualified laboratory or providing training to a receiving laboratory. International travel may be required.

QUALIFICATIONS

• BS in Chemistry or related science. (1-2 years experience in analytical chemistry preferred)
• Familiar with GMP concepts
• Academic exposure and familiarity with the majority of the following: HPLC, GC, UV-Vis spectroscopy, dissolution, Karl Fischer, titration, FTIR, and wet chemistry.
• Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems.
• Advanced computer skills specifically in Microsoft Word, Excel.
• Refined written and verbal communications and presentation skills.
• Strong organizational skills, ability to manage and complete assigned projects on time

GMP DECISION-MAKING AUTHORITY

The…