Upstream Manufacturing Associate II/III

Upstream Manufacturing Associate II/III

Rockville, MD

Permanent, Direct-Hire Opportunity

Full-Time, Day-Shift

 

Position Summary: The Upstream Manufacturing Associate applies a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical and commercial stage medicines to dramatically improve the human condition through gene therapy. 

 

Responsibilities

  • Perform basic to complex activities in seed train, bioreactor, transfection and recovery operations for both suspension and adherent cultures using SOPs and Batch Production Records.
  • Document of all activities in Batch Records, Logbooks, Forms, Etc.
  • Follow verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
  • Exercise intellectual curiosity by identifying and escalating events and subtle variances that deviate from normal operation
  • Participate as needed in investigations
  • Monitor processes using automated production systems and controls with limited supervision.
  • Prepare, sanitize, and disinfect equipment to prevent microbial contamination
  • Demonstrate ability to troubleshoot basic mechanical operations.
  • Conduct training for less experienced personnel
  • May work with Process Development team and collaborate with Technology Transfer and Support group to transfer new projects into GMP
  • Perform buffer preparations, in-process sampling
  • Perform other tasks as assigned that ensures sustainable right-first-time performance and delights client customers

 

Requirements

Required Skills & Abilities:

  • Technical understanding of both suspension and adherent cell culture processes
  • Extensive hands-on experience with single-use bioreactor systems (GE XDR, WAVE at different scales) and recovery approaches (ATF, depth filtration, TFF)
  • Experience producing Master and Working cell banks (mammalian, insect, viral)

Qualifications:

  • Upstream Manufacturing Associate III:
    • Bachelor’s degree in Science or Engineering with 3-5 years’ experience with upstream biologic production processes in a GMP environment
      • High School Diploma/Associate’s with 4-10 years’ experience with upstream biologic production processes in a GMP environment
  • Upstream Manufacturing Associate II:
    • Bachelor’s degree in Science or Engineering with 1-3 years’ experience with upstream biologic production processes in a GMP environment or
      • High School Diploma/Associate’s with 2-7 years’ experience with upstream biologic production processes in a GMP environment

Desired but not required qualifications:

  • Previous work in viral or vaccine production highly desired
  • Training in Lean Six Sigma
  • Experience in biologics fill/finish
  • Previous experience in contract manufacturing

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 90 of the Fortune 100 companies and found opportunities for more than 10,000 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.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.

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