Scientist, Bioassay (Potency), Gene Therapy
SUMMARY OF POSITION
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.
The Scientist position will serve as a bench scientist in cell-based potency assays of the analytical development group to support the gene therapy pipeline and other programs. The role will support establishing and will routinely run the potency assays to support characterization, formulation development, process development and manufacturing of Amicus' pipeline.
ROLES AND RESPONSIBILITIES
The Scientist is responsible for:
Major activities include potency related analysis (cell based assay, others as needed) of gene therapy products to support characterization, method development/optimization, methods transfer and analytical support of process development and manufacturing
Support preparation of Master and Working cell banks with associated documentation
Support of development, qualification and validation of potency assays including tech transfer to CRO/CMOs
Author/review method development reports, SOPs, validation protocols/reports, comparability protocols and technical reports
Help build the scientific knowledge and analytical capabilities in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.
EXPERIENCE AND SKILLS
Extensive hands-on experience with development and routine testing using cell-based potency assays for biologic products including data analysis. Experience with AAV testing is a strong plus.
Experience working with various cell lines
Experience in CMC analytical and regulatory requirements, including qualification and validation of batch release assays is desirable
Familiar with other analytical methods used for biologics/gene therapy characterization including qPCR is a plus
Team oriented, flexible and able to manage multiple projects
Detail-oriented with good verbal and written communication
Amicus Therapeutics, Inc.