FSP Scientist, Particle Imaging

What You'll Do

• Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
• Work with multiple functional groups to meet business needs.
• Plan and organize work with periodic supervision.
• Set up and maintain analytical instrumentation.
• Train in routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
• Ensure QA findings are addressed appropriately.
• Provide assistance and training for other team members.
• Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.
• Communicate project status to project leader.
• Perform work assignments accurately, and in a timely and safe manner.
• Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Education and Experience

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Demonstrated knowledge of multiple applicable techniques such as: HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC
• Proficiency in Microsoft Excel and Word
• Proven ability to interpret data by performing trend analysis
• Proven ability in technical writing skills
• Ability to independently optimize analytical methods
• Proven problem solving and troubleshooting abilities
• Good written and oral communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team