US-MA-Marlborough: Sr. Director Clinical Bioanalytical Chemistry

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Date: 26-Feb-2008

Sr. Director Clinical Bioanalytical Chemistry

Responsibilities The primary objective of this position is to the development and validation of bioanalytical methods in human biological matrices. The incumbent will also be responsible for assuring successful implementation of these validated bioanalytical methods in support of all clinical pharmacokinetic programs and reporting of the bioanalytical results. This position will have supervisory responsibilities It is also expected that the incumbent will maintain a state of the art awareness of new developments in the field of bioanalytical chemistry and apply them to the development process where appropriate. The incumbent will also be responsible for human ADME studies.

Experience required 7 - 10 Years Experience and other requirements The primary objective of this position is to the development and validation of bioanalytical methods in human biological matrices. The incumbent will also be responsible for assuring successful implementation of these validated bioanalytical methods in support of all clinical pharmacokinetic programs and reporting of the bioanalytical results. This position will have supervisory responsibilities It is also expected that the incumbent will maintain a state of the art awareness of new developments in the field of bioanalytical chemistry and apply them to the development process where appropriate. The incumbent will also be responsible for human ADME studies.

ESSENTIAL FUNCTIONS REQUIRED FOR JOB

1. Work with contract research organizations (CRO) to develop and validate bioanalytical method in human biological matrices.

2. Maintain a high level of quality and timely delivery of all bioanalytical validation reports in human biological matrices.

3. Assure successful implementation of these validated bioanalytical methods at one or more CRO’s in support of all assigned clinical studies (including documentation of sample receipt and analysis)

4. Provide bioanalytical data and bioanalytical report from clinical trials on a timely basis and assure that all bioanalytical quality control specifications as described in the validation protocol/ SOP’s have been documented and met. Assure compliance with all internal and external procedures/SOP’s in the conduct of supporting clinical studies including regulatory requirements.

5. Responsible for supervising preparation of bioanalytical data bases for standard pharmacokinetic analysis. Supervise quality assurance of the bioanalytical data base and appropriate documentation.

6. Supervise the bioanalysis and reporting of human ADME data.

7. Work with CRO to provide exploratory in vivo metabolic profile of new chemical entities in man using LC/MS/MS analytical methodology on an as needed basis

8. Maintain a state of the art awareness of new developments in the field of bioanalytical chemistry. Apply this knowledge to novel Sepracor development projects.

9. Represent clinical pharmacology group on selected project teams

Sr. level:

10. Act as a mentor to more junior scientists within the group

11. In conjuction with direct reports, develop a career growth and development plan

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BioTech FYI Center
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