Research Scientist

ClinLab Solutions Group; Pennsylvania; On-site; USD 70,000 - 90,000; Full time

Job summary

ClinLab Solutions Group is looking for a detail-oriented laboratory scientist to support research and development activities. This role involves conducting laboratory testing, method validation, and ensuring compliance with regulatory standards.

The ideal candidate will have a BS or MS in Chemistry with 5+ years of R&D experience, proficient in HPLC, GC, and analytical techniques, and strong documentation skills.

Qualifications

• 5+ years of relevant R&D experience in analytical testing and method validation.
• Hands-on experience with routine testing of drug substances and products.
• Understanding CMC regulatory requirements for product development.

Responsibilities

• Conduct laboratory analyses ensuring accurate results.
• Document activities maintaining thorough records.
• Adhere to regulatory guidelines for laboratory compliance.
• Prepare reagents and assist with inventory management.
• Design and develop analytical methods for drug product development.

Skills

Analytical method development

Attention to detail

Regulatory compliance

Proficiency in HPLC

Team collaboration

Education

BS or MS in Chemistry or related field

Tools

HPLC

GC

TLC

Job description

Seeking a detail-oriented laboratory scientist to support analytical research and development activities. This role involves routine laboratory testing, method development and validation, and ensuring compliance with regulatory and quality standards. The position requires a strong commitment to accuracy, documentation, and laboratory best practices.

Responsibilities

• Conduct laboratory analyses using established methods and standard operating procedures, ensuring accurate and reliable results.
• Document all laboratory activities, maintaining thorough and precise records in both physical and electronic formats.
• Adhere to cGMP, GLP, and safety guidelines, supporting a compliant and audit-ready laboratory environment.
• Prepare reagents, solutions, and samples, and assist with inventory management and equipment maintenance.
• Independently design and develop new analytical methods and improve existing ones to support drug product development.
• Lead method verification, validation, and transfer activities, including collaboration with external partners.
• Author technical documents such as analytical test methods, validation reports, and protocols.
• Participate in peer review of laboratory notebooks and collaborate with project teams to meet deadlines and deliverables.

Qualifications

• BS or MS in Chemistry or a related field with 5+ years of relevant R&D experience.
• Experience in analytical method development, verification, validation, and method transfer.
• Hands‑on experience with routine testing and characterization of drug substances and products.
• Proficiency in analytical techniques and instrumentation, including HPLC, GC, TLC, in‑vitro dissolution, and physical characterization methods (e.g., DLS, TEM/SEM, zeta potential).
• Ability to work effectively in a fast-paced, multi-disciplinary environment with shifting priorities.
• Understanding of CMC regulatory requirements for pharmaceutical product development.
• Familiarity with data acquisition systems and cGMP policies and practices.