Principal chemist vs product development chemist

Differences between principal chemist and product development chemist duties and responsibilities

Principal chemist example responsibilities.

• Accomplish ISO and CFR certifications for laboratory operations.
• Ensure compliance with regulate standards to comply with FDA regulations.
• Train individuals on dissolution, HPLC, and other general analytical techniques.
• Implement systems and procedures per FDA guidance, ICH requirements, and CFR regulations.
• Establish statistical quality controls in the laboratory to bring data and laboratory practices in compliance with ISO regulations.
• Evaluate efficacy of extraction solvents and dosing methodology for soil degradation studies, determining reduction of chemical compounds in control environment.
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Product development chemist example responsibilities.

• Lead a collaboration with another biotechnology company to design ELISAs for the purpose of evaluating novel reagents.
• Execute HPLC method development and method validation to provide data toward supporting specification, and testing of reference materials.
• Write and review work instructions and maintain ISO paperwork.
• Develop and implement CAPA as an outcome of investigations.
• Create validation protocols, OOS reports and final reports for test methods.
• Authore and revise operating procedures to reflect changes in the testing methods to comply with ISO requirements.
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