Manufacturing Associate III / IV, Cell Culture (Days)

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 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).

• 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

• 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.
• 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.

• 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 2 years of direct experience
  • A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience
  • A High School Diploma (or equivalent) and at minimum of 3 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 working in an aseptic or cleanroom environment.
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.).
• Demonstrated troubleshooting skills on Incubators, Laminar Flow Hoods, Bioreactors, and Single Us Systems.

• Ability to climb ladders, work in tight spaces, and lift/move equipment up to 50 lbs.
• Must be comfortable working in cleanroom environments with required gowning and able to stand for up to 3 hours at a time.

• 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