Senior Research Investigator II, Bioassay (Potency)Gene Therapy

Position Summary This position will serve as a leader and SME in potency area (qPCR, cell based assay, ELISA) of the analytical development group tosupport the gene therapy pipeline. The role will establish and routinely run the potency assays tosupport characterization, formulation development, process development and manufacturing of gene therapy products.  Roles and Responsibilities  Major activities include potency related analysis (qPCR, cell based assay, ELISA) of gene therapy products to support characterization, method development/optimization, methods transfer and analytical support of process development and manufacturing. The role requires managing CRO/ CMOs in addition to in-house work.  Serve as technical expert and SME in cross-functional team to review analytical data and provide guidance on method development and product characterization.  Author/review method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and other relevant sections of regulatory filings (IND, IMPD, BLA, etc.).  Advance Amicus scientific and regulatory approaches via active participation and leadership across industry trade groups and conferences.  Supervise, mentor and troubleshoot for junior scientists. Build the scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.  Define science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture    Requirements A PhD in molecular biology, virology, biochemistry or related field with 5+ years of relevant experience. Hands on experience in potency assays for virus products.   Experience and Skills Deep knowledge and hands-on experience with development of potency assays for virus products.  Familiar with other analytical methods used for gene therapy characterization. Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization. Experience in interacting with CROs/CMOs is preferred Team oriented and able to manage multiple projects across various development stages. Strong leadership, team building, organizational, communication and interpersonal skills. Excellent oral and writing skills.    Travel Position requires up to 10% USA and International travel 1437
Salary Range: NA
Minimum Qualification
5 - 7 years

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