Clinical Assay Laboratory Analyst

Exciting opportunity for experienced Clinical Assay Laboratory Analyst to join a clinical-stage biotech company developing innovative bacteriophage therapies addressing the global crisis of antibiotic-resistant bacterial infections. 

The Clinical Laboratory Analyst will participate in the performance of clinical testing related to APT products under GLP/GCLP conditions in the Clinical Assay laboratories. Conduct clinical testing (viral plaque assays, clinical specimen processing, neutralizing antibody testing, phage and bacterial quantification, genomic extractions, PCR). Assist in the conduct and reporting of clinical testing including phage susceptibility, antibiotic susceptibility, antibiotic-phage interaction, and phage-phage interaction in planktonic and biofilm-associated bacterial species. This testing will directly support APT's expanded access programs and APT's sponsored clinical trials (Phase 1-3).  Assist in assay transfer, qualification, and validation activities.

Responsibilities

• Performs clinical assay testing related to APT products under GLP/GCLP conditions.
• Performs sample management activities, e.g., receipt/log-in, storage, and retrieval for samples submitted to the Clinical Assay Lab.
• Performs preparation and shipment of samples to external contract testing laboratories.
• Reports and participates in the investigation of Clinical Assay Lab related deviations and out-of-specification results.
• Write technical documents such as reports, change controls, and SOPs.
• Participates in testing for analytical method qualification/validation.
• Maintains the Clinical Assay Lab and equipment in a clean and organized state.
• Other duties as assigned.

Qualifications

• Microbial cell culture and aseptic technique under BSL-2 conditions.
• Understanding of GLP/GCLP compliance in the Clinical Assay Lab.
• High level of attention to detail.
• Ability to manage multiple priorities with a sense of urgency to meet timelines.
• Adaptable to change.
• Comfortable working in teams and independently.
• Bachelor of Science degree / equivalent in life sciences or related field.
• 1-3 years of experience in pharmaceutical or biotechnology Clinical Assay Lab.
• Experience with viral plaque assays is a plus.
• Working knowledge of GLP/GCLP regulations.
• Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint)

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