SUMMARY OF POSITION

The Method Development and Analytical Services (MDAS) Research Associate I is a technical resource performing the analytical testing necessary to support development and commercialization of new pharmaceutical products. The MDAS Research Associate I is responsible for performing the bench chemistry testing for release, stability and product characterization. The MDAS Research Associate I performs laboratory work independently commensurate with training and experience.

ORGANIZATION STRUCTURE

The Research Associate I typically reports to a Group Supervisor/Leader, Manager or Director. The Research Associate I may guide the activities of junior staff.

RESPONSIBILITIES

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  Performs 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.
• Perform laboratory work for method validation/verification/transfer, equipment maintenance and calibration, reference standards qualification, drafting methods/reports, training, and other work as required under the guidance of senior staff.
• 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.
• Provides training and guidance to junior staff on specific techniques as directed by management and specified training plans.
• Processes sample data to determine reported result. Ensure results are reported appropriately in designated computerized systems and/or directly to stakeholders.
• Evaluates data to ensure conformance with specifications, expectations, and trends. Identifies and investigates unexpected results.
• Peer review experimental documentation, calculations, and results generated by other staff for conformance with established procedures and scientific integrity.
• Complies with laboratory procedures and SOPs. Follows written and verbal direction from senior staff to execute tasks and work 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.

QUALIFICATIONS

• BS in Chemistry or related science plus 2 years experience in a pharmaceutical analytical laboratory.
• Familiar with GMP concepts related to pharmaceutical quality control
• Practical hands-on experience with the majority of the following: HPLC, GC, UV-Vis spectroscopy, dissolution, Karl Fischer, titration, FTIR, wet chemistry and USP/EP compendial test procedures.
• Strong analytical aptitude, ability to apply knowledge and experience 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 Research Associate I has authority to perform work as assigned supporting the laboratory function. This includes following approved procedure and guidance received from supervisors.

“An Equal Opportunity Employer, including disability/vets.”