Research Associate II

SUMMARY OF POSITION

The Method Development and Analytical Services (MDAS) Research Associate II is an experienced resource in performing sample testing and validating the methods necessary to support development and commercialization of pharmaceutical products. The MDAS Research Associate II is responsible for performing the bench chemistry testing of pharmaceutical products supporting development of new products, incoming transfer of existing products, and analytical support of product life cycle management. The MDAS Research Associate II will assist in performing method development, transfer, validation, and/or verification for methods related to analyzing raw materials, semi-finished/finished products, and stability. Customer communication and active participation as the analytical chemistry expert on work teams may be required.

ORGANIZATION STRUCTURE

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

RESPONSIBILITIES

• 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).
• Validate analytical methods necessary for commercialization of pharmaceutical products. This includes evaluating validation/verification/transfer requirements, equipment acquisition/installation, reference standards/reagents, drafting protocols, methods/reports, training, specification development, and other steps as required.
• Authoring and reviewing 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.
• 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.
• Works in conjunction with senior staff to provide scientific contributions toward improvement, troubleshooting, method development and validation.
• Works through problems with method installation / acts quickly, efficiently, and relentlessly until root cause is determined and solution is found.
• Provides training and guidance to junior staff on specific techniques as directed by management and specified training plans.
• Interacts with project teams as required to obtain information, influence decisions, and drive the project forward. Serves as the analytical expert and contributing member on project teams.
• 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 to receive training from a qualified laboratory or provide training to a receiving laboratory. International travel may be required.

QUALIFICATIONS

1. BS in Chemistry or related science, plus 4 years experience in a pharmaceutical development or QC laboratory (Equivalent combination of experience and education will be considered; ex. PhD in chemistry with analytical laboratory experience).
2. Familiar with GMP regulations and ICH guidelines
3. Extensive experience with expertise in the majority of the following: HPLC, GC, dissolution, UV-Vis, X-ray Diffraction, Karl Fischer, IR, PSD, wet chemistry, and USP/EP compendial test procedures.
4. Experience with chromatographic data acquisition systems such as Empower, ChemStation etc. (Empower greatly preferred)
5. Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems.
6. Advanced computer skills specifically in Microsoft Word, Excel.
7. Refined written and verbal communications and presentation skills.
8. Strong organizational skills, ability to manage and complete assigned projects on time.

GMP DECISION-MAKING AUTHORITY

The Research Associate II has authority to perform work as assigned supporting the laboratory function or supporting development and validation of analytical procedures. This includes following approved procedure and guidance received from supervisors.

"An Equal Opportunity Employer, including disability/vets."

"This role will offer a base salary that commensurate with experience and demonstrated skills with a range of $62,000 - $65,000.00.