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1+ months

Analytical Development Contractor-ELISA, Immunoassay, PCR

Kelly Services
Pennington, NJ 08534
**Kelly Services is currently assisting our client fill a temp-to-permanent Analytical Development Contractor role in Pennington, NJ**


The Contract, Analytical Development, Molecular Assays - Gene Therapy 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.


The incumbent works cross-functionally with internal departments and external resources as appropriate on analytical development-related issues.


The Contract, Analytical Development, Molecular Assays - Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.


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**Job Description:**


+ 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.


**KNOWLEDGE/SKILLS/ABILITIES REQUIRED**


* Minimum level of education and years of relevant work experience.


+ PhD in molecular biology, virology, biochemistry or related field OR a Masters 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.


* Special knowledge or skills needed and/or licenses or certificates required.


+ 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.


**APPLY NOW!**


**For immediate consideration please send your resume in a WORD document to Gauri at gaut985@kellyservices.com**


\#TJP2021_SPEC


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-24 Expires: 2021-11-25

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Analytical Development Contractor-ELISA, Immunoassay, PCR

Kelly Services
Pennington, NJ 08534

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