PLS Scientist III

Job 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.
• Carry out 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.
• Investigate 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.
• Collaborate 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.

Job Qualifications

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

Physical/Mental Requirements

• Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time.
• Erecting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects.
• Vision to read printed materials and computer screens.
• Hearing and speech to communicate in person or over the telephone.

Benefits

• Competitive salaries.
• Medical, dental, vision, and disability insurance.
• 401K retirement savings plan (100% vested immediately in the employer match).
• Life and disability insurance.
• Voluntary benefits.
• Paid time off for holiday, sick and vacation days.
• HSA.
• Wellness program.
• Flexible spending accounts.
• Tuition reimbursement.
• Employee Assistance program.
• Parental leave.
• Optional legal coverage and ID theft protection.

About the Role

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.

Qualifications

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

Skills

• Data analysis.
• Chromatographic interpretations.
• Technical report writing.
• Method development.
• Validation activities.
• Out-of-specification (OOS) and out-of-trend (OOT) investigations.
• Training and mentorship.
• Microsoft Office Suite proficiency.

Benefits

• Comprehensive benefits program including competitive salaries, medical, dental, vision, and disability insurance.
• 401K retirement savings plan (100% vested immediately in the employer match).
• Life and disability insurance.
• Voluntary benefits.
• Paid time off for holiday, sick and vacation days.
• HSA.
• Wellness program.
• Flexible spending accounts.
• Tuition reimbursement.
• Employee Assistance program.
• Parental leave.
• Optional legal coverage and ID theft protection.

Pay

$85,000 - $95,000 per year

Schedule

Full-time, onsite, Monday through Friday, 8:00 a.m. - 5:00 p.m.