Senior Biochemistry Consultant
2 weeks ago
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.
Interested? Please apply today for immediate consideration
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