18 days old

Analytical Development, Molecular Assays

Kelly Services
South Plainfield, NJ 07080
**Kelly Services is seeking a Contract, Analytical Development, Molecular Assays - Gene Therapy for a 6month assignment, which has the possibility to extend or convert.**

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.

**Primary duties/responsibilities:**

+ 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 and justification of specifications.

+ 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.

+ 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.


Minimum level of education and years of relevant work experience.

+ PhD in molecular biology, virology, biochemistry or related field OR a Master s degree in these same disciplines and a minimum of 2 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


**For immediate consideration please send your resume to**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-16 Expires: 2022-10-17

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Analytical Development, Molecular Assays

Kelly Services
South Plainfield, NJ 07080

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