About This Role
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.
Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 PM – 6:00 AM ET)
Internal Shift Details: Black Nights rotating schedule
Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them.
Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP).
This role’s primary focus is on Upstream Cell Culture operations:
Mammalian cell culture & harvest:
Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L
Performing thaws and splits utilizing Aseptic technique
What You’ll Do
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
Who You Are
You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.
Required Skills for a Manufacturing Associate II: $23.56 - $30.77 Pay Range
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 direct experience
A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of direct experience
A High School Diploma (or equivalent) and at minimum of .5 years of direct experience
Previous experience in a GxP 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 Skills for a Manufacturing Associate III: $25.96 - $34.13 Pay Range
The following combination of academic and/or relevant experience may be considered: Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience
A High School Diploma (or equivalent) and at minimum of 1.5 years of direct 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 Delta V, Syncade, or similar systems
Experience performing bioreactor preparation, inoculation, and monitoring is preferred
Hands-on experience with mammalian cell culture operations is preferred
Preferred Skills
Bachelor’s degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited…