Analytical Chemist - Method Development & QC (cGMP)

ClinLab Solutions Group; Horsham (PA); On-site; USD 65,000 - 90,000; Full time

Job summary

ClinLab Solutions Group in Montgomery County, PA is seeking a detail-oriented Chemist to join a dynamic laboratory environment. You will perform hands-on analytical testing, develop and validate methods, and ensure compliance with cGMP and regulatory standards.

The role requires strong analytical skills, the ability to manage multiple priorities, and effective collaboration with cross-functional teams to deliver accurate results on time.

Qualifications

• Bachelor’s degree in Chemistry from an accredited US college or university.
• Minimum of 3 years of laboratory experience in a cGMP environment.
• Proficiency with analytical instrumentation such as HPLC, UPLC, dissolution, GC, KF, ICP-MS, and viscometers.
• Experience with analytical method development or validation is highly desirable.
• Familiarity with electronic laboratory systems (LIMS, ELN) and standard office software (Excel, Word).
• Strong critical thinking, problem-solving, and communication skills.
• Demonstrated stability in work history and ability to adapt in a fast-paced environment.

Responsibilities

• Conduct analytical testing of raw materials, in-process samples, stability, and finished products using HPLC, UPLC, dissolution, and other instrumentation.
• Develop, validate, and execute analytical methods, ensuring compliance with cGMP and regulatory standards (USP, ICH, CFR).
• Maintain, calibrate, and schedule laboratory equipment, ensuring operational readiness and adherence to protocols.
• Utilize electronic laboratory systems (LIMS, ELN) for data entry, documentation, and reporting of results.
• Perform stability studies, schedule testing, and support laboratory operations to meet project deadlines.
• Collaborate with team members to troubleshoot issues, prevent deviations, and continuously improve laboratory processes.
• Train colleagues in laboratory techniques and cGMP procedures, fostering a culture of quality and compliance.
• Engage in cross-functional communication to support business development, client interactions, and regulatory documentation.

Skills

Analytical testing

cGMP knowledge

Regulatory documentation

Quality control

Education

Bachelor's degree in Chemistry

Tools

HPLC

UPLC

Dissolution

GC

KF

ICP-MS

Viscometers

Job description

ClinLab Solutions Group in Montgomery County, PA is seeking a detail-oriented Chemist to join a dynamic laboratory environment. You will perform hands-on analytical testing, develop and validate methods, and ensure compliance with cGMP and regulatory standards.

The role requires strong analytical skills, the ability to manage multiple priorities, and effective collaboration with cross-functional teams to deliver accurate results on time.