Senior Analytical Chemist for Drug Development & Validation

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 85,000 - 110,000; Full time

Job summary

Sharp Clinical Services seeks an Analytical Chemist III to independently perform routine and non-routine analyses on drugs and materials using instrumental and wet chemistry techniques.

The role includes leading projects, developing methods, authoring reports, and mentoring junior staff within a cGMP-regulated laboratory environment. Collaboration with cross-functional teams and adherence to SOPs are essential.

Qualifications

• BS or BA in Chemistry with 5+ years analytical drug development experience.
• MS in Chemistry with 2+ years analytical drug development experience.
• PhD in Chemistry with at least 1 year analytical drug development experience.

Responsibilities

• Perform routine and non-routine analysis on raw materials, drug substances, reference materials and drug products using various instrumental and wet chemistry techniques.
• Independently design and execute method development and validation activities for pharmaceutical drug product development.
• Author protocols and reports as needed.
• Serve as a dedicated project leader and SME for analytical testing requirements for drug development and regulatory submissions.
• Mentor and guide junior chemists and participate in client project meetings.

Skills

HPLC analysis

Dissolution testing

Moisture determination

Analytical drug development

Project leadership

Documentation & cGMP

Oral and written communication

Education

Bachelor's in Chemistry

Master's in Chemistry

PhD in Chemistry

Tools

HPLC instrumentation

Dissolution apparatus

Moisture analyzers

Job description

Sharp Clinical Services seeks an Analytical Chemist III to independently perform routine and non-routine analyses on drugs and materials using instrumental and wet chemistry techniques.

The role includes leading projects, developing methods, authoring reports, and mentoring junior staff within a cGMP-regulated laboratory environment. Collaboration with cross-functional teams and adherence to SOPs are essential.