Kelly Services Process Engineer - Gaithersburg, MD in Gaithersburg, Maryland
Kelly Scientific Resources has an exciting opportunity as an Process Engineer to support the development and characterization of lentiviral vectors manufactured for pre-clinical studies and clinical gene therapy products.
Statistical design/analysis software experience will allow you to utilize JMP Design of Experiment (DoE) and Statistics software to analyze previous data and perform studies to identify critical and non-critical process parameters as well as execute scale-down model qualifications.
Perform risk assessments and FMEA, identifying TPP based critical and non-critical performance parameters.
Identify design space and define control ranges for existing and new methods of viral vector production
Draft characterization study protocols/reports and work with Development, Analytical, and pre-Clinical manufacturing Process Development team members to ensure a robust, scalable production process
B.S.(+6 yrs), M.S. (+4 yrs), or Ph.D. (+2 yrs) in life sciences or chemical engineering and late stage biopharm industry product development experience
In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
Knowledgeable in Quality-by-Design and previous experience incorporating QbD principles into product development
Experienced creating, reviewing, and updating FMEA risk assessment due to new processes or changes that potentially impact product
Experienced in one, or both, of the following areas:
Bioreactor based production of biologics incorporating batch, fed-batch, or perfusion modes
Purification methods that include Harvest clarification, chromatography, Tangential flow filtration (TFF, UF/DF)
Familiar with analytical methods used in the characterization of Lentiviral vectors (ELISA, Flow Cytometry, qPCR, ddPCR, Western-blot, HPLC, Nanoparticle analysis (NTA, FFF, TRPS, etc.)
Superb documentation, organizational, and technical writing skills, capable of providing summaries and reports with little direct oversight
Highly motivated, independent, detail-oriented team player. Good organization, initiative, and a collaborative attitude are essential
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.