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 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 approximately $10,000 per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
