Small Molecule Regulated Bioanalytical Leader, Principal Scientist, or Senior Principal Scientist, Northeast Pharmaceutical Company, Position 440

POSITION DESCRIPTION:

The small molecule bioanalytical leader (regulated bioanalysis) will provide GLP bioanalysis support for toxicology and clinical PK studies.

RESPONSIBILITES:

· Develop and Validate LC/MS/MS assays for drugs and metabolites in biological matrices

· Support sample analysis for TK and clinical studies as needed

· Review and approve data and reports

· Ensure compliance with the regulations and SOPs

· Provide scientific and technical leadership to the group

· Proactively collaborate with partners and customers to achieve continuous process improvement

· Manage resources and study timelines for projects.

· Provide scientific and technical leadership, mentoring and guidance to the staff

· Advance bioanalytical science and technology

· Integrate existing and implement new technologies into routine bioanalysis, including laboratory automation, robotics and novel separation and sample preparation techniques.

· Lead the continuous enhancement of productivity via process and technology improvements

· Conduct external and internal presentations

QUALIFICATIONS:

MINIMUM:

· PhD in Pharmaceutical Sciences, Analytical Chemistry or related discipline with 3+ years of experience or equivalent

· Deep knowledge and experience in the area of GLP and familiar with regulatory requirement on conducting regulated bioanalysis

· Provide scientific and technical leadership to the group

· Proactively collaborate with partners and customers to achieve continuous process improvement

· Excellent communication and interpersonal skills are required

DESIRABLE:

· Experience with managing resources and project timelines

· Experience with assay transfer and troubleshooting with CROs, assessment and
interpretation of the scientific data generated by CRO

· Strong publication records

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