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.