Position Summary

The Scientist II, Analytical Development demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought.  Works on complex problems in which analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Essential Functions (ES) and Responsibilities

• Develop, qualify, validate analytical and bioanalytical test methods and assays with minimum supervision, write SOPs and transfer methods to QC department as needed.
• Be familiar with regulatory guidelines pertaining to assay development/qualification/validation and support regulatory submissions.
• Design experiments and write protocols for assay qualification and development.
• Perform assays or supervise other analysts for assay qualification and validation work.
• Frequently write technical reports and present findings internally to management or to external clients.
• Analyze experimental data with appropriate statistical tools and report scientific results.
• Interpret data and adhere to strict guidelines on documentation when recording data.
• Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary.
• Analyze samples from various sources to provide information on compounds or quantities of compounds present.
• Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC), ion chromatography, spectroscopy (infrared and ultraviolet amongst others), ELISA, and potentiometry.
• Use a range of analytical techniques, instrumentation and software and serve as a subject matter expert.
• Develop new techniques for the analysis of drug products and chemicals.
• Use judgment, creativity and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
• Constantly observe current QC methods and propose areas for improvement.
• Perform risk and gap assessment and life cycle of the existing methods/systems in support of FDA’s requirement for continuous improvement.
• Propose efficiencies to existing processes and be familiar with laboratory automation.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements:     

A minimum of a Master's degree in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent is required.

Experience Requirements:   

A minimum of five years of related employment experience is required with a Master's degree. Three years of experience (may include post-doctoral experience) is required for a PhD.  Expert knowledge of scientific principles and concepts is required.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.