Senior Biochemistry Consultant

Kelly Science is seeking a Senior Chemistry Consultant for a contract position for a growing company located near Princeton, NJ. The Senior Chemistry Consultant with be responsible for assay validations, method transfers and quality control testing of biological products.

Employment Type: 6 month contract with possible extension

Job Duties:

Perform quality control chemistry assay validation and transfer activities.

Lead method transfer and method validation activities which include protocol preparation and execution and report preparation.

Testing of drug substance and drug product release and stability samples and reporting results in support of manufacturing operations.

Provide support with general laboratory operations including instrument qualifications and maintenance, writing new SOPs and revising existing SOPs, determining and revising existing specification requirements, and documentation of testing records.

Take lead on laboratory investigations such as OOS, OOT, deviations, invalid assays, and associated corrective actions.

Assist with internal and external audits when needed.

Qualifications:

Bachelor's degree in chemistry, biochemistry or a scientific related field

5+ years of experience with analytical methods for biological products, experience with monoclonal antibodies specifically is a strong plus.

Experience with analytical instrumentation such as HPLC, UPLC, Container Closure Integrity (CCIT), UV Spectrophotometer for quantification, assay validation and transfer activities.

Strong knowledge of cGMP, USP/EP and ICH guidelines.