Manufacturing Associate II & III – Cell Culture (Nights)

Role Summary

Manufacturing Associate II & III – Cell Culture (Nights) supports Upstream Cell Culture operations in the Drug Substance facility in Research Triangle Park (RTP). The role works in a 24/7 manufacturing environment with 12-hour night shifts on a 2-2-3 calendar rotation (6:00 PM – 6:00 AM ET), operating under cGMP and SOPs.

Responsibilities

• Perform inoculation thaws, splits, and pools using aseptic technique with WAVE bags and ITV cans
• Prepare bioreactors by executing automated CIP/SIP recipes using DeltaV
• Standardize and calibrate pH and DO probes during bioreactor preparation
• Perform inoculation of bioreactors across multiple scales
• Support cell growth operations, including media feeds and process additions
• Conduct routine sampling and in-process testing to monitor product quality
• Standardize and maintain laboratory and manufacturing equipment, including:
  • Vi-Cell Blu/XR
  • Osmometer
  • pH meters
  • RapidPoint BGA
  • Conductivity meters
  • Biosafety cabinets
  • Small-scale centrifuges
• Accurately document activities in accordance with cGMP and SOP requirements
• Maintain a clean, safe, and compliant manufacturing environment
• Collaborate cross-functionally with Manufacturing, MSAT, Quality, and Engineering teams

Qualifications

• Required: Manufacturing Associate II:
  • The following combination of academic and/or relevant experience may be considered:
  • Bachelor’s degree from an accredited college or university, STEM preferred and 0+ years of related experience
  • A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of related experience
  • A High School Diploma (or equivalent) and at minimum of 1 year of related experience
• Previous experience in a cGMP environment
• Ability to follow SOPs and work effectively on shift schedules if required
• Demonstrated documentation and data integrity skills
• Understanding of aseptic technique and cleanroom practices is preferred
• Required: Manufacturing Associate III:
  • The following combination of academic and/or relevant experience may be considered:
  • Bachelor’s degree from an accredited college or university, STEM preferred and 2+ years of related experience
  • A BioWorks Certificate or associate's degree, STEM preferred and 2.5+ years of related experience
  • A High School Diploma (or equivalent) and at minimum of 3 years of related experience
• Previous experience in a cGMP environment
• Ability to follow SOPs and work effectively on shift schedules if required
• Demonstrated documentation and data integrity skills
• Knowledge of aseptic technique and cleanroom practices
• Exposure to DeltaV, Syncade, or similar systems
• Experience performing bioreactor preparation, inoculation, and monitoring is preferred
• Hands-on experience with mammalian cell culture operations is preferred

Education

• II: Bachelor’s degree (STEM preferred) with 0+ years related experience; BioWorks Certificate or associate’s degree (STEM preferred) with 0+ years; High School Diploma with at least 1 year related experience
• III: Bachelor’s degree (STEM preferred) with 2+ years related experience; BioWorks Certificate or associate’s degree (STEM preferred) with 2.5+ years; High School Diploma with at least 3 years

Skills

• Aseptic technique and cleanroom practices
• DeltaV, Syncade, or similar systems (experience preferred)
• Documentation and data integrity