Manager, Translational Sciences | BioNJ Talent Services

Manager, Translational Sciences

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHART™) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The Translational Sciences department is a key contributor to Amicus’ process of clinical development for rare and orphan diseases. Translational Sciences has oversight over all specialty lab contract research organizations (CROs) that support both clinical studies, as well as providing support for non-clinical GLP toxicology studies. The Manager in Translational Sciences will be responsible for interfacing with internal scientific experts and with external CROs to manage bioanalytical assay development and validation under applicable regulations and guidances to support specialty lab measurements in early and late stage pivotal clinical trials. Responsibilities will include setting up vendor contracts, participating in vendor audits, and managing all aspects of the method development, validation, study sample analysis, and reporting of data.

Roles and Responsibilities
The Manager in Translational Sciences will be responsible for interfacing with internal scientific experts and with external CROs to manage bioanalytical assay development and validation under applicable regulations and guidances to support specialty lab measurements in early and late stage pivotal clinical trials.
Responsibilities will include setting up vendor contracts, participating in vendor audits, and managing all aspects of the method development, validation, study sample analysis, and reporting of data.

Qualifications: 

Requirements
PhD degree or equivalent education and/or experience in a bioanalytical, biological, or biochemical field
A minimum of 5 years of experience in a biotech, pharma, or CRO.

Experience and Skills
Experience must include a combination of laboratory and project management skills, including managing CROs for assay development and validation.
Scientific expertise in assessing immune responses, particularly neutralizing antibody (NAbs) immunogenicity of protein therapeutics is required.
Technical expertise with a wide variety of technical platforms to assess NAbs that may include complex sample handling and preparation procedures (e.g., LC-MS/MS, enzymatic assays, ligand-binding assays, cell-based assays, etc… from serum or plasma samples) is required.
Demonstrated expertise in GLP compliance of sample handling, bioanalytical assay validation and performance, sample analysis, and laboratory operation procedures and processes is required.
Ability to clearly and proactively communicate assay development and validation work in real-time to internal scientific experts and to appropriately incorporate feedback in a timely fashion is required.
Ability to conduct on-site visits to CROs to review core capabilities and lab processes, raw data, etc… to ensure GLP compliance and assay data quality, and/or to evaluate and assess the capabilities of new CROs, is required.
Ability to manage project resources and timelines for deliverables is required.
A demonstrated sense of urgency and ability to work independently and under tight deadlines is required.

Travel
0-25%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Clinical Operations