Research Assoicate - Bioanalytical Chemistry
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Description
Research Associate (Bioanalytical Chemistry) – Drug Development
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules to restore or improve biological activity in cells by selectively binding to misfolded proteins caused by genetic mutations. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its lead compound, AT1001, for Fabry disease, has completed Phase 1 clinical trials of AT2101 for Gaucher disease and is conducting Phase 1 clinical trials of AT2220 for Pompe disease.
The company is headquartered in Cranbury, NJ. Amicus has a fast-paced, high-energy, entrepreneurial team environment where employees are encouraged to be innovative and resourceful. Amicus seeks high-caliber, talented individuals with a passion to succeed. Additional information on the company, product pipeline, and technology is available at www.amicustherapeutics.com.
Responsibilities
* Hands-on responsibility for all aspects of bioanalytical work to support the Company's development portfolio of small molecule therapeutics and biomarkers.
* Responsibility for various stages of LC-MS/MS assay development and application in the quantitation of drug and metabolite concentrations in body fluids and tissue samples that will support the internal discovery operation.
* Activities to include method development and validation for active drug and PD markers.
* Compile data and write protocols and reports. Communicate analytical data across scientific departments.
* Proficient in the use of automated sample preparation techniques. Ability to use standard word processing and spreadsheet applications in the finalization and reporting of final results.
* Calibrate and maintain MS instrumentation. Evaluate new and emerging analytical technology in support of development projects.
* Establish and implement laboratory systems that maximize efficiency and regulatory compliance in a growing analytical laboratory.
* Interact closely with Regulatory Affairs providing summary data and reports required for regulatory submissions.
Requirements
Education & Requirements
Our environment requires that the candidate be both a hands-on innovative scientist and an effective project manager. The candidate should have a B.S or MS in analytical chemistry or a related field with 6-8 years of relevant experience in quantitative bioanalytical techniques involving the extraction and analysis of small molecules and biomarkers from biological samples including tissue samples. Candidate should have extensive hands-on experience using the Sciex LC/MS platforms and have a thorough understanding of GLPs. Proficiency with personal computer applications for word processing, spreadsheets and graphics, as well as good oral and written communication skills are desirable. Technical writing ability and familiarity with regulatory submissions (IND, NDA, CTD format) is preferred.
Description
Research Associate (Bioanalytical Chemistry) – Drug Development
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules to restore or improve biological activity in cells by selectively binding to misfolded proteins caused by genetic mutations. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its lead compound, AT1001, for Fabry disease, has completed Phase 1 clinical trials of AT2101 for Gaucher disease and is conducting Phase 1 clinical trials of AT2220 for Pompe disease.
The company is headquartered in Cranbury, NJ. Amicus has a fast-paced, high-energy, entrepreneurial team environment where employees are encouraged to be innovative and resourceful. Amicus seeks high-caliber, talented individuals with a passion to succeed. Additional information on the company, product pipeline, and technology is available at www.amicustherapeutics.com.
Responsibilities
* Hands-on responsibility for all aspects of bioanalytical work to support the Company's development portfolio of small molecule therapeutics and biomarkers.
* Responsibility for various stages of LC-MS/MS assay development and application in the quantitation of drug and metabolite concentrations in body fluids and tissue samples that will support the internal discovery operation.
* Activities to include method development and validation for active drug and PD markers.
* Compile data and write protocols and reports. Communicate analytical data across scientific departments.
* Proficient in the use of automated sample preparation techniques. Ability to use standard word processing and spreadsheet applications in the finalization and reporting of final results.
* Calibrate and maintain MS instrumentation. Evaluate new and emerging analytical technology in support of development projects.
* Establish and implement laboratory systems that maximize efficiency and regulatory compliance in a growing analytical laboratory.
* Interact closely with Regulatory Affairs providing summary data and reports required for regulatory submissions.
Requirements
Education & Requirements
Our environment requires that the candidate be both a hands-on innovative scientist and an effective project manager. The candidate should have a B.S or MS in analytical chemistry or a related field with 6-8 years of relevant experience in quantitative bioanalytical techniques involving the extraction and analysis of small molecules and biomarkers from biological samples including tissue samples. Candidate should have extensive hands-on experience using the Sciex LC/MS platforms and have a thorough understanding of GLPs. Proficiency with personal computer applications for word processing, spreadsheets and graphics, as well as good oral and written communication skills are desirable. Technical writing ability and familiarity with regulatory submissions (IND, NDA, CTD format) is preferred.
posted by Declan Fallon at
7:31 AM
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