Job Title: Research Scientist Analytical R&D

Work Location: Bucks County, Pennsylvania

Summary:

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.
• Knowledge of cGMP and ICH requirements.

Published Category: Analytical & Process Development