Research Associate II

SUMMARY OF POSITION

The Analytical R&D 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 Research Associate II is responsible for performing the analytical testing of pharmaceutical products supporting development of new products, and analytical support of product life cycle management. The 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 samples.

ORGANIZATION STRUCTURE

The Analytical R&D Research Associate II reports to the Principal Scientist or Research Fellow, Analytical R&D.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Conducts laboratory testing with high degree of accuracy and precision including but not limited to quantitative weighing, pipetting, titration and dilution, sample handling and processing, instrumental analysis using HPLC, GC, dissolution, UV-visible spectrophotometry, Karl Fischer, physical property evaluation equipment, and other techniques as required.
• Perform routine sample testing with a minimum of supervision to support development of pharmaceutical products, including assay, related compounds testing, dissolution, uniformity, residual solvents and physical testing following for raw materials, finished products, and/or stability samples.
• 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 analysis with a practical understanding of the test procedure and instrument operation. Evaluates data to ensure conformance with specifications, expectations, and trends. Identifies and investigates unexpected results.
• Works through problems with method installation / acts quickly, efficiently, and relentlessly until root cause is determined and solution is found.
• Conduct pre-validation of analytical methods to expedite method validation at the GMP site. This includes evaluating validation/verification/transfer requirements, equipment acquisition/installation, reference standards/reagents, preparing and executing study plan, evaluating the outcome, and optimizing the method as required.
• Works in conjunction with senior staff to provide scientific contributions toward improvement, troubleshooting, method development and validation.
• Provides training and guidance to junior staff on specific techniques as directed by management and specified training plans.
• Peer review experimental documentation, calculations, and results generated by other staff for conformance with established procedures and scientific integrity.
• Organize work schedule to complete assigned tasks efficiently and on schedule.
• Maintain accurate record of analysis, following all company good documentation practices.
• Complies with laboratory procedures and SOPs. Perform job functions in a safe manner consistent with site safety practices and regulatory (e.g. - OSHA) requirements. 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
• Other duties as assigned

QUALIFICATIONS

• BS or MS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
• 1-3 years experience for MS or 2-4 years experience for BS in a pharmaceutical development laboratory environment
• 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.
• Understanding of cGXP requirements preferred
• Strong analytical aptitude, ability to apply knowledge and experience analytical techniques to solve problems
• Advanced computer skills specifically in Microsoft Word, Excel
• Strong organization, communication and interpersonal skills. ability to manage and complete assigned projects on time

GMP DECISION-MAKING AUTHORITY

Responsible for decisions related to:

• When laboratory management must be notified to determine whether an investigation is warranted.
• Whether they have been trained to perform a GMP task.
• Suitability of analytical equipment/instruments for use.

We are an EEO Employer, including disability & vets.