Kincellbio

Manufacturing Associate I - Contingent

Gainesville, FL. Posted a month ago

The role

The Manufacturing Associate I will support manufacturing operations using Microsoft Office applications. The role involves aseptic processing, cell culture, and cell therapy manufacturing within a cGMP-regulated environment.

What you will do

  • Utilize Microsoft Word, Excel, and PowerPoint to support manufacturing operations.
  • Apply knowledge of aseptic processing, cell culture, and cell therapy manufacturing in a cGMP environment.
  • Maintain strict adherence to personal protective equipment requirements.
  • Collaborate with cross-functional teams to draft, revise, and maintain SOPs.
  • Perform Quality Control evaluations for in-process and final product assessments.
  • Demonstrate understanding of material flow and disinfection procedures for cleanroom areas.
  • Maintain a safe work environment and complete assigned training on time.
  • Partner with the Investigation team to support root cause analysis and corrective/preventive actions.
  • Apply GXP principles to daily operations.
  • Execute cleaning and sanitization procedures for equipment and cleanroom facilities.

Required qualifications

  • High school diploma or equivalent
  • 0–2 years of relevant education and/or experience in a related field
  • Ability to work 40 hours per week, including weekends as needed
  • Ability to work independently and maintain focus in a fast-paced environment
  • Strong attention to detail
  • Effective verbal communication skills
  • Ability to work collaboratively within a team-oriented environment
  • Consistent, reliable performance and attendance
  • Adaptability to change
  • Proficient in basic math, including unit conversions
  • Understanding of significant figures and proper rounding practices
  • Physically capable of lifting and pushing loads of 50+ pounds

Nice to have

  • Bachelor’s degree in Natural Sciences (e.g., Biology, Chemistry) or Engineering (e.g., Chemical, Biomedical) with 0–2 years of relevant manufacturing experience
  • Hands-on experience working in a cGMP-compliant cleanroom setting
  • Familiarity with cell and gene therapy manufacturing processes, including use of the metric system and laboratory scales

About the company

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers. They provide GMP infrastructure across autologous and allogeneic therapies.

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