Manufacturing Associate II & III – Cell Culture (Nights)
About The Position
This requisition represents multiple open positions in our manufacturing organization. The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to prospective candidates to discuss current and future opportunities. 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 nights (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.
Requirements
- Previous experience in a cGMP environment
- Ability to follow SOPs and work effectively on shift schedules if required
- Demonstrated documentation and data integrity skills
Nice To Haves
- Understanding of aseptic technique and cleanroom practices is preferred
- 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
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
