Manufacturing Associate III / IV, Cell Culture (Days)
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. Shift Details : This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET) Internal Shift Details : Red Days Rotation Our Manufacturing Associates perform processing steps and manufacturing support activities in our Large Scale Manufacturing 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 at minimum .5 years of direct experience OR A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience OR A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience
- Previous experience in a cGMP environment.
- Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP).
- Experience or understanding of working in an aseptic or cleanroom environment.
- Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.).
- Previous pipetting experience in a laboratory or manufacturing environment preferred.
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience OR A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience OR A High School Diploma (or equivalent) and at minimum of 3 years of direct experience
- Demonstrated troubleshooting skills on Incubators, Laminar Flow Hoods, Bioreactors, and Single Us Systems.
Nice To Haves
- Previous pipetting experience in a laboratory or manufacturing environment preferred.
Responsibilities
- Work in and help maintain a safe working environment
- Perform and monitor critical upstream processes and troubleshoot operational and equipment problems
- Help maintain cleanliness and audit readiness of process area
- Perform, document, and review cGMP manufacturing activities according to standard operating procedures, solution lot records and batch production records, both paper and electronic
- Perform in-process sampling and sampling analysis (pH, Osmolarity, Cell Counts, etc.)
- Production and filtration activities
- Upstream bioreactor processing
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
