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.

Duties:

  • 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

Qualifications:

  • 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

with us on Facebook , LinkedIn and Twitter .

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.