This role actively contributes to, and provides scientific Subject Matter Expertise (SME) for, assays (qPCR, ddPCR, cell-based, immunoassay) in support of the gene therapy analytical development group. This involves collaborating with scientific leadership within the analytical development organization to help establish, and routinely run, the characterization assays necessary to support the discovery, formulation development, process development and manufacturing of gene therapy products..
location: Pennington, New Jersey
job type: Contract
salary: $50 - 55 per hour
work hours: 9 to 5
- Actively contributes to the development and execution of the product characterization analyses (qPCR, cell-based assay, immunoassay) required to support method development activities associated with the process development and manufacturing of gene therapy products.
- Contributes to the scientific advancement of activities conducted in-house or by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs).
- Provides technical expertise within the analytical development team to review and trend analytical data for product characterization.
- May contribute to authoring and/or reviewing method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and other relevant sections of regulatory filings. These include, but may not be limited to, INDs, IMPDs and BLAs.
- Assists in advancing scientific and regulatory capabilities by maintaining and actively advancing his/her knowledge regarding relevant topics. S/he may also participate in industry trade groups and conferences.
- May oversee or mentor junior scientists. This includes providing scientific and technical support to help troubleshoot and solve scientific challenges.
- Builds the scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.
- Actively contributes to, and assures the development of, science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
- Performs other tasks and assignments as needed and specified by management.
- PhD in molecular biology, virology, biochemistry or related field OR a Master's degree in these same disciplines and a minimum of 5 years of relevant and progressively responsible experience in biologics and/or gene therapy analytical roles.
- Hands-on/applied experience with the development of analytical assays for virus products.
- Demonstrated understanding of other analytical methods used for gene therapy characterization.
- Experience in CMC analytical and regulatory requirements are preferred - including the determination of product specifications and extended analytical characterization.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development.
- Experience in interacting with CROs/CMOs.
- Small company and/or start-up experience.
skills: Molecular Biology, Assay Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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