Core Technician I

Katalyst CRO; Houston (TX); On-site; USD 50,000 - 75,000; Full time

Job summary

Katalyst CRO in Houston seeks an Environmental Monitoring Core Technician to perform EM tasks in support of GMP production and aseptic processing of clinical grade products. The role includes maintaining and stocking clean room environments and collaborating with QC EM teams.

You will operate EM equipment (Solairs, ApexZ50), draft batch records and EM forms, and assist with buffer prep and sterilization. A strong background in aseptic techniques, cell culture, and lab documentation is required;

Qualifications

• Aseptic technique and hands-on experience with cell culture and serological methods preferred.
• Computer skills including Microsoft Office, strong organization, recordkeeping, and ability to manage multiple projects.

Responsibilities

• Participates in the Environmental Monitoring process as part of GMP production of viral therapies
• Cell culture and product purification using aseptic technique when required
• Coordinates EM equipment needs with QC EM team for Manufacturing processes
• Drafting, completion and revision of manufacturing documents including Batch Records and EM forms
• Buffer and component preparation including operation of steam autoclave
• Operation of manual, semi-automated and automated equipment in support of routine clinical production
• Operating Environmental monitoring equipment such as Solairs, ApexZ50, active counters

Skills

Aseptic technique

Cell culture

Serological methods

MS Office

Recordkeeping

Time management

Communication

Teamwork

Independent work

Lab experience

Education

Bachelor's degree in Life Sciences

High school diploma

Intermediate lab experience

cGMP clinical production experience

Tools

Solairs

ApexZ50

Job description

Job Description

The Environmental Monitoring (EM) Core Technician will be responsible for conducting EM tasks in support of production and aseptic processing of clinical grade products. The core tech will also be responsible for maintaining, stocking, and set-up of clean room environment.

The Environmental Monitoring (EM) Core Technician will be responsible for conducting EM tasks in support of production and aseptic processing of clinical grade products. The core tech will also be responsible for maintaining, stocking, and set-up of clean room environment.

Responsibilities

• Participates in the Environmental Monitoring process as part of GMP production of viral therapies
• Cell culture and product purification using aseptic technique when required
• Coordinates EM equipment needs with QC EM team for Manufacturing processes
• Drafting, completion and revision of manufacturing documents including Batch Records and EM forms
• Buffer and component preparation including operation of steam autoclave
• Operation of manual, semi-automated and automated equipment in support of routine clinical production
• Operating Environmental monitoring equipment such as Solairs, ApexZ50, active counters

Requirements

• Aseptic technique and experience in cell culture and serological methods preferred
• Able to pass Class 10,000 gowning qualification
• Computer software skills including Microsoft Office, organization skills, recordkeeping skills, ability to manage multiple projects, time management skills.
• Written and oral communication skills, team oriented, independent work skills, strong work ethic
• 1-3 Years Experience
• Basic Lab experience with a Bachelor's degree or Intermediate Lab experience within a cGMP clinical production environment and a High School Diploma.
• Lab experience preferred.
• Bachelor's Degree in Life Sciences preferred