Bioanalytical Scientist

A pharmaceutical company in New Jersey is currently seeking a new Bioanalytical Scientist, GxP Bioanalytical to join their team on a contract basis. With guidance, the Bioanalytical Scientist will be responsible for performing the quantitative analysis of biological samples in support of small and large molecules clinical and/or preclinical development.

Responsibilities:

• Develop, validate, and qualify bioanalytical assays and conduct regulated bioanalysis


• Oversee the scientific quality of the bioanalytical projects in support of clinical and/or preclinical development


• Support in writing analytical reports


• Comply with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)


• Maintain a detailed laboratory notebook


• Perform other duties, as needed

Qualifications:

• 5 years of experience and progressively responsible experience in Regulated Bioanalysis of Clinical / Preclinical samples (plasma, urine, cells, etc.)


• Bachelor's, Master's and/or Ph.D. in Biology, Chemistry, Biochemistry, Pharmaceutical Science, Pharmacology, or other related Scientific discipline


• Demonstrated experience applying analytical techniques to the regulated Bioanalysis of Clinical / Preclinical samples (plasma, urine, cells etc.) using LC-MS/MS, quantitative PCR (qPCR), ELISA, Mesoscale Discovery (MSD) and flow cytometry techniques


• Applied understanding and knowledge of Bioanalytical method validation guidelines governed by FDA or other global health authorities


• Possesses detailed and expert knowledge of Scientific principles and concepts


• Proficiency with Microsoft Office. particularly MS Excel and MS PowerPoint


• Excellent verbal and written communication and skills


• Analytical thinker with excellent problem-solving skills

Desired Skills:

• Experience in writing analytical reports, laboratory operating procedures and work instructions


• Experience in working within or with a Contract Research Organization (CRO)