Cell based Assay and Ligand Binding Principal Investigators

The Cell based assay position requires cell-based assay with cell culture experience. The other requires ELISA method development, ADA, PK, NAB experience.

The PI is responsible for the conduct of studies and serves as point of contact for clients. Ideal candidates should have experience interpreting, analyzing and reporting the results of data for method development and validation of biopharmaceutical products.

Essential Position Responsibilities:

•             Responsible for client interaction and the conduct of studies.

•             Responsible for data interpretation, analysis, and reporting of results for method development and validation of biopharmaceutical products.

•             Responsible for the data interpretation of biologics, vaccines, and analysis of preclinical and clinical samples.•               

 Ligand-binding assays (ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies is required or cell based assay experience.

•             Must understand contract immunoanalytical business objectives and is expected to be

•             familiar with regulatory, and GLP requirements, FDA guidelines and industry standards for bioanalytical method validation.

•             Knowledge of Watson LIMS a plus.

Job Requirements:

•             Bachelors degree in Biology (or related field) and a minimum of 10 years of relevant experience in CRO industry or related field,

•             Advanced degree in Biology or related field and at least 5 years of relevant experience.

•             Knowledge of GLP regulations and regulatory guidelines.

•             Excellent communications skills, both oral and written.

•             Strong leadership and organization skills.

•             Proficient in the use of basic computer applications such as MS Word and Excel.

•             Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.

•             Proficient in time management and resource planning.

•             Ability to initiate and implement self-development efforts.

•             Ability to effectively interact with clients and regulatory personnel.

•             Ability to make decisions and complete assignments with minimal supervision.

Suzette Grimm, Sage Staffing, 732-974-9600

Send resume asap. Interviewing now.