Experienced Analytical Chemist (Pharma)

Pace® Analytical Services•Oakdale, MN

1d•$60,000 - $70,000

About The Position

The PLS Scientist II at Pace Analytical Life Sciences, LLC is responsible for performing a variety of complex laboratory analyses, studies, and method development activities in a GxP regulated environment. This role contributes to the development and validation of analytical methods, executes testing plans, and interprets data to support pharmaceutical and biopharmaceutical product development and quality control.

Requirements

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field with 3-5 years of relevant experience in a GxP regulated laboratory environment; or a Master's degree with 1-3 years of relevant experience.
Proven hands-on experience with a variety of analytical techniques, including advanced chromatography (HPLC, GC) and mass spectrometry (LC-MS).
Strong understanding of GxP (GLP/GMP) regulations and their application in a laboratory setting.
Experience in analytical method development, optimization, and validation is highly desirable.
Proficiency in data analysis, interpretation, and technical report writing.
Familiarity with LIMS (Laboratory Information Management System) and other laboratory software.
Excellent problem-solving skills and attention to detail.
Strong communication (written and verbal) and interpersonal skills, with the ability to work effectively in a team environment.
Ability to manage multiple projects concurrently and meet deadlines.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Responsibilities

Execute complex analytical testing including but not limited to HPLC, GC, LC-MS, dissolution, spectroscopy (UV/Vis, FTIR), and wet chemistry techniques, following established SOPs and GxP guidelines.
Conduct method development, optimization, and validation activities for various analytical methods, ensuring suitability for intended purpose and compliance with regulatory requirements.
Analyze and interpret data, troubleshoot analytical issues, and provide clear, concise reports and summaries of experimental results.
Operate, maintain, and calibrate laboratory instrumentation, ensuring proper functioning and adherence to preventative maintenance schedules.
Document all experimental procedures, observations, and results accurately and thoroughly in laboratory notebooks and LIMS systems.
Participate in the investigation of out-of-specification (OOS) and out-of-trend (OOT) results, identifying root causes and implementing corrective actions.
Contribute to the drafting and revision of Standard Operating Procedures (SOPs), test methods, and validation protocols.
Work collaboratively with project teams, providing scientific expertise and support to achieve project goals and timelines.
Ensure compliance with all safety regulations, GxP standards, and internal quality policies.
Provide training and mentorship to junior scientists and laboratory personnel as needed.