AR&D Chemist: Method Development & Validation

Formulated Solutions; Largo (FL); On-site; USD 85,000 - 115,000; Full time

Job summary

Formulated Solutions in Largo, FL, is seeking an AR&D Chemist to develop, transfer, and validate analytical methods for raw materials, in-process and finished products, and stability samples using HPLC, GC, ICP, and AA.

This role ensures cGMP compliance, data integrity, and thorough documentation, and provides mentoring to Chemist I/II while collaborating with QA, Validation, and other SMEs to resolve analytical challenges.

Qualifications

• Bachelor’s degree in Chemistry or a related scientific discipline.
• Minimum of three years of experience in an analytical laboratory within an FDA-regulated industry.
• Hands-on experience with analytical method development, transfer and validation.
• Demonstrated knowledge of cGMP and data integrity principles.
• Experience with USP/Ph. Eur./JP testing expectations.

Responsibilities

• Develop, transfer, and validate analytical methods for raw materials, in-process samples, finished products, and stability samples.
• Prepare, review, and revise analytical test methods, protocols, SOPs, and technical reports.
• Execute approved protocols and document conclusions and deviations.
• Troubleshoot analytical methods and instruments with cross-functional support.
• Support cleaning validation activities through analytical testing and validation.
• Maintain complete, accurate laboratory records for data integrity and compliance.
• Investigate out-of-spec results and contribute to CAPAs and root-cause analyses.
• Provide technical guidance and mentoring to Chemist I and II, and collaborate with QA and Validation teams.

Skills

Analytical method development

Transfer & validation

cGMP knowledge

Good Documentation Practices

Data integrity

Analytical instrumentation

Troubleshooting

Documentation & reporting

Communication skills

Mentoring

Education

Bachelor's degree in Chemistry or related

Tools

HPLC

GC

ICP

AA

UV-Vis spectroscopy

IR spectroscopy

Job description

Formulated Solutions in Largo, FL, is seeking an AR&D Chemist to develop, transfer, and validate analytical methods for raw materials, in-process and finished products, and stability samples using HPLC, GC, ICP, and AA.

This role ensures cGMP compliance, data integrity, and thorough documentation, and provides mentoring to Chemist I/II while collaborating with QA, Validation, and other SMEs to resolve analytical challenges.