Scientist, Bioassay (Potency), Gene Therapy

Amicus Therapeutics, Inc. Cranbury , NJ 08570

Posted 2 months ago

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.

REQUIREMENTS

  • BS or equivalent in molecular biology, virology, biochemistry or related field, and minimum of 7-10 years related lab experience, or MS and 5-7 yrs experience or, equivalent combination of education
  • experience

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

TRAVEL

  • Up to 5% travel
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