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24 days old

Analytical Development Sr. Scientist - San Diego, CA

Kelly Services
San Diego, CA 92108
**Analytical Development Sr. Scientist - San Diego, CA**



**Job Description:** Position Summary:

This position will be responsible for leading and executing the analytical development strategy for our preclinical and clinical scale candidates in development. The candidate will be expected to work in collaboration with our internal research group, process development group, as well as our external manufacturing and analytical development partners to identify, develop, and implement appropriate analytical methods to characterize AAV based gene therapy products across our pipeline. The successful candidate will be a subject matter expert in contemporary analytical methods used to support biological products and will be required to identify and mitigate quality risks to enable successful product development. The successful candidate will also contribute to the preparation of quality sections of INDs and other regulatory documents. As an early stage startup this position will require flexibility, creativity and a can-do attitude to enable efficient execution of company objectives. The level of the position will be commensurate with experience.



**Key responsibilities:**

Contribute to the development and qualification of analytical methods for the release and characterization of AAV gene therapy products, in process controls, and starting materials in support of early phase clinical development

Optimize and execute test methods to support of AAV based process development activities (e.g. viral genome titer, capsid titer, cell-based potency, SDS-PAGE, residual impurity characterization)

Identify, evaluate, and implement novel analytical technologies for finished products, in process methods, and starting materials.

Participate in the writing/reviewing method qualification protocols to ensure compliance with regulatory guidances.

S/he will be highly communicative and function at a high level in a matrixed management environment.


**Key Requirements:**

Degree in Biochemistry, Cell and Molecular Biology, Genetics or related discipline. Scientist level applicants should have a PhD in Biochemistry OR a Masters degree with >5 years of relevant experience; Senior Scientist level applicants should have a PhD, a post-doc, and >2 years of relevant experience

Hands-on experience optimizing and executing AAV testing and characterization techniques such as: ddPCR, qPCR, SDS-PAGE, ELISA, Western blots, Capillary Electrophoresis, Analytical Ultracentrifugation, HPLC and cell- based potency and infectivity assays

Experience working with viral vectors for gene therapy and with contract research or manufacturing organizations is ideal



**_For immediate consideration apply today!_**



**_Questions? Please reach out to Dustin at DUSG877@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: 2021-04-19 Expires: 2021-05-20

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Analytical Development Sr. Scientist - San Diego, CA

Kelly Services
San Diego, CA 92108

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