Bioanalytical Assay Services, Principal or Senior Principal Scientist, two positions, one for Small Molecules and one for Large Molecules, Northeast Pharmaceutical Company, Position 443

Client seeks to establish two GLP compliant bioanalytical laboratories to support sample analysis from non-clinical and clinical studies of biotherapeutics. One lab is for small molecules (using LC/MS/MS) and one for large molecules (using ELISA).

RESPONSIBILITES:

Head a GLP compliant bioanalytical laboratory, overseeing projects and ensuring timeliness and quality of sample analysis and data delivery. Assume responsibility for overseeing strict adherence to appropriate SOPs and other guidelines as they pertain to method validation, sample analysis and data analysis; ensure communication and collaboration with the development laboratories and the compliance and study logistics groups that support the laboratory infra-structure; serve as Principal Investigator for multi site studies and as validation director for assay validation studies; manage a team of associates to meet the goals of compliant sample analysis as well as to mentor their professional development.

QUALIFICATIONS:

The ideal candidate will have a Ph.D. in biological sciences with a minimum of 8-10 years experience in drug development in industry in the areas of bioanalytical assay development and sample analysis to support registration-enabling studies. Extensive and in-depth knowledge in assay methodologies used for pharmacokinetic, immunogenicity and pharmacodynamic measurements and other associated laboratory procedures is a must. Prior experience and understanding of GLP guidelines as it pertains to sample analysis and laboratory compliance is essential. Excellent oral and written communication skill is expected.

Please email your CV/Resume to cv@mspeople.net