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30 days old

Bioprocess Engineer

Kelly Services
Gaithersburg, MD 20898
Every day, Kelly Scientific Resources connects scientific professionals with opportunities to advance their careers, and we currently have a direct-hire opening for an Bioprocess Engineer near Gaithersburg, MD.



Responsibilities:




+ Perform process risk assessments and design and execute characterization studies

+ Identify Design space and define Process control ranges for viral vector production

+ Draft characterization study protocols/reports and work with Development, Analytical, and pre-Clinical manufacturing team members to ensure a robust, scalable production process and control strategy

+ Utilize JMP Statistics software

+ Technical writing in support of CMC decumentation





Requirements:




+ B.S. or advanced degree in life sciences or chemical engineering

+ 5+ years experience in late stage biologics development

+ Knowledge of FDA, EMA, GMP, and ICH regulatory requirements

+ Demonstrates expertise in biologics process characterization and validation preferred

+ Knowledgeable in Quality-by-Design (QbD) and previous experience incorporating QbD principles

+ Experienced creating and updating risk assessments due to new processes or changes that potentially impact product

+ Experience in one or both of the following areas:

+ Bioreactor based production of biologics incorporating batch, fed-batch, or perfutison modes

+ Purification methods that include clarification, chromatography, and Tangential flow filtration

+ Familiar with analytical methods (ELISA, Flow Cytometry, qPCR, ddPCR, Western-blot, HPLC, Nanoparticle analysis)

+ Strong documentation, organizational, and technical writing skills

+ Capable of writing summaries and reports with little direct oversight










**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-12-25 Expires: 2021-01-25

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Bioprocess Engineer

Kelly Services
Gaithersburg, MD 20898

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