Analytical Chemist III: cGMP & Drug Development Lead

Sharp Packaging Solutions, part of UDG Healthcare plc; Bethlehem (Northampton County); On-site; USD 85,000 - 110,000; Full time

Job summary

Sharp Packaging Solutions in Bethlehem, PA seeks an Analytical Chemist III to perform routine and non-routine analysis on raw materials, drug substances, reference materials, and drug products using diverse chemistry techniques.

The role includes leading analytical testing projects on a limited basis, authoring protocols and reports, mentoring junior chemists, and ensuring compliance with cGMP, FDA and ICH guidelines while maintaining lab documentation.

Qualifications

• BS or BA in Chemistry or related physical science with 5+ years of analytical drug development in a pharmaceutical lab.
• MS in Chemistry or related field with 2 years of analytical drug development experience preferred.
• PhD in Chemistry or related field with at least 1 year of analytical drug development experience preferred.
• Experience in HPLC analysis, dissolution, and moisture determination preferred.
• Excellent oral and written communication skills.
• Experience interpreting cGMPs, ICH, FDA, DEA and OSHA guidelines.
• Ability to work effectively and independently.
• Proficiency with MS Office including Word, Project, and Excel.

Responsibilities

• Perform routine and non-routine analysis on raw materials, drug substances, reference materials and drug products using a variety of instrumental and wet chemistry techniques.
• Independently design and execute method development and validation activities for pharmaceutical drug product development on a limited basis.
• Author protocols and reports as needed.
• Serve as a dedicated project leader and subject matter expert for analytical testing requirements for drug development and regulatory submissions on a limited basis.
• Mentor and guide junior chemists on a limited basis.
• Attend client project meetings related to analytical testing timelines on a moderate basis.
• Conduct laboratory testing in accordance with methods, protocols, SOPs and cGMP guidelines.
• Prepare and review documentation such as laboratory notebooks, validation and analysis reports, SOPs, methods and monographs.
• Develop systems that are cost effective and increase efficiency.
• Interface with all departments as necessary.
• Adhere to set safety standards.

Skills

HPLC analysis

Dissolution testing

Moisture determination

Communication skills

cGMP knowledge

Regulatory knowledge

Independent work

Project leadership

Excel proficiency

Team mentorship

Education

Bachelor's degree in Chemistry or related physical science

Master's degree in Chemistry or related physical science

PhD in Chemistry or related physical science

Tools

HPLC instrumentation

Microsoft Word

Microsoft Project

Microsoft Excel

Job description

Sharp Packaging Solutions in Bethlehem, PA seeks an Analytical Chemist III to perform routine and non-routine analysis on raw materials, drug substances, reference materials, and drug products using diverse chemistry techniques.

The role includes leading analytical testing projects on a limited basis, authoring protocols and reports, mentoring junior chemists, and ensuring compliance with cGMP, FDA and ICH guidelines while maintaining lab documentation.