Manufacturing Associate II/III – Cell Culture (Nights)
About The Position
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. This role follows a 2-2-3 calendar rotation on nights (6:00 PM – 6:00 AM ET) with a rotating Red Nights 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.
Requirements
- Bachelor’s degree from an accredited college or university, STEM preferred and 0+ years of direct experience (for Associate II)
- A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of direct experience (for Associate II)
- A High School Diploma (or equivalent) and at minimum of .5 years of direct experience (for Associate II)
- Previous experience in a GxP environment (for Associate II)
- Ability to follow SOPs and work effectively on shift schedules if required (for Associate II)
- Demonstrated documentation and data integrity skills (for Associate II)
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience (for Associate III)
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience (for Associate III)
- A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience (for Associate III)
- Previous experience in a cGMP environment (for Associate III)
- Ability to follow SOPs and work effectively on shift schedules if required (for Associate III)
- Demonstrated documentation and data integrity skills (for Associate III)
- Knowledge of aseptic technique and cleanroom practices (for Associate III)
- Exposure to Delta V, Syncade, or similar systems (for Associate III)
Nice To Haves
- Understanding of aseptic technique and cleanroom practices is preferred (for Associate II)
- Experience performing bioreactor preparation, inoculation, and monitoring is preferred (for Associate III)
- Hands-on experience with mammalian cell culture operations is preferred (for Associate III)
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
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
