PLS Scientist III

Pace® Analytical Services•Oakdale, MN

1d•$85,000 - $95,000•Onsite

About The Position

Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future. The PLS Scientist III 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 or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field with 5-10 years of relevant experience in a GxP regulated laboratory environment;
Proven hands-on experience with a variety of analytical techniques, including advanced chromatography (HPLC, UPLC, GC) and mass spectrometry (LC-MS).
Strong understanding of GxP (GLP/GMP) regulations and their application in a laboratory setting.
Proficiency in data analysis, chromatographic interpretations, and technical report writing.
Strong communication (written and verbal) and interpersonal skills, with the ability to work and lead effectively in a team environment.
Familiarity with LIMS (Laboratory Information Management System) and other laboratory software.
Excellent trouble-shooting, problem-solving skills and attention to detail.
Ability to manage multiple projects concurrently and meet deadlines.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

Nice To Haves

Experience in analytical method development, optimization, and validation is highly desirable.
Experience providing technical guidance, mentoring, or informal leadership is strongly preferred.

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 supporting coordination 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.