Senior PLS Scientist – Method Development & QC (Onsite)

RXinsider LTD.; Oakdale, Northern (MN, KY); Hybrid; USD 85,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

401K retirement plan

Paid time off

Life insurance

Disability insurance

Tuition reimbursement

Employee assistance program

Job summary

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.

Our Scientist III role conducts complex laboratory analyses in a GxP environment, develops and validates analytical methods, executes testing, and interprets data to support product development and quality control, onsite in Oakdale, MN.

Qualifications

• Bachelor's or Master's in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5–10 years in a GxP lab.
• Hands-on experience with HPLC, UPLC, GC and LC-MS in regulated environments.
• Strong knowledge of GLP/GMP/GxP regulations.
• Experience in method development, optimization, and validation is desirable.
• Proficient in data analysis and technical reporting.

Responsibilities

• Perform complex analytical testing including HPLC, GC, LC-MS, Dissolution, spectroscopy, and wet chemistry per SOPs and GxP.
• Develop, optimize, and validate analytical methods.
• Analyze data, troubleshoot issues, and report results clearly.
• Operate, maintain, and calibrate laboratory instruments and perform preventive maintenance.
• Document experiments thoroughly in notebooks and LIMS.
• Investigate OOS/OOT results and implement corrective actions.
• Contribute to SOPs, test methods, and validation protocols.
• Collaborate with project teams to meet timelines.
• Ensure compliance with safety, GxP, and quality policies.
• Provide training and mentorship as needed.

Skills

Analytical testing

Chromatography

Data analysis

Technical reporting

Team leadership

Problem solving

Microsoft Office

LIMS familiarity

Education

BSc/ MSc in Chemistry / Biochemistry / Pharmaceutical Sciences

Tools

LC-MS

HPLC/UPLC/GC

LIMS

Job description

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.

Our Scientist III role conducts complex laboratory analyses in a GxP environment, develops and validates analytical methods, executes testing, and interprets data to support product development and quality control, onsite in Oakdale, MN.